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Tuesday, March 25th, 2008
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* A Jan. 1 story incorrectly described the Consumer Product Safety Commission. The CPSC is an independent federal agency that has the authority to obtain product recalls, impose mandatory safety standards and ban dangerous products.
* A Dec. 18, 2000, brief incorrectly stated that Stockton Re had placed into runoff all Crowe Syndicate Management Ltd. syndicates at Lloyd’s of London except 963 and 982. Crowe’s professional indemnity and medical malpractice syndicate 1204 is not in runoff and will be capitalized by a non-Crowe corporate member in 2001 while continuing to be managed by Crowe.
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Tuesday, March 25th, 2008
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WASHINGTON: China, a traditional source of cheap goods, has become an alarmingly top exporter of tainted and dangerous products to the United States, triggering concerns among consumers and regulators.
Reports of tainted pet foods, dangerous toys, fake drugs, toxin-coated monkfish and cosmetics, drug-laced frozen eel, illicit pesticide-laden mushrooms and other products have led to recalls and bans and potentially more stringent import and food safety laws.
Thousands of cats and dogs died recently after eating food made from wheat gluten spiked with melamine, a chemical used in fertilizers, prompting one of the largest pet-food recalls in US history. Made-in-China toothpaste have also been blacklisted, fearing it may contain a potentially deadly chemical reportedly found in tubes sold in Australia and elsewhere.
The concerns were compounded by the recall last week by a US company of 1.5 million of the wildly popular “Thomas and Friends” wooden train toys manufactured in China coated with potentially poisonous lead paint. Chinese-made fireworks for the July 4 US Independence Day celebrations have also made it onto the blacklist, with reports that at least two types of such explosives have been recalled amid worries they could “travel in unexpected and dangerous directions” and pose “special hazards to eyes and bystanders.” “I think we have reached a point unfortunately where ‘made in China’ is now a warning label in the United States,” said Democratic Senator Richard Durbin, a top campaigner in the US Congress for tighter food safety laws.
The Illinois lawmaker and another senator, Rosa DeLauro from Connecticut, held joint talks with US Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach and the Chinese ambassador, Zhou Wenzhong, in Washington over the contaminated shipments of food products from China.
They secured a commitment from the Chinese government and the FDA that they would work towards a mutual agreement to improve inspections and overall safety of food products and drugs, said a statement from the two senators. “This proposed agreement between the FDA and the Chinese government is a significant breakthrough in terms of food safety- and American consumers stand to be the big winners,” Durbin said. China and the FDA currently do not have a binding agreement on food and drugs, there is no standard safety regulations between the two systems, and there are no mechanisms in place to inspect food production facilities and secure travel visas for investigations, the statement said.
The food safety problem surprisingly took center stage at the high level US-China Economic dialogue last month led by Treasury Secretary Henry Paulson and Chinese Vice-Premier Wu Yi. Following her return, China promised to overhaul its food safety rules. “The top priority for building a food safety standards system is to revise as soon as possible the rules for farm produce and processed food,” said the director of the General Administration of Quality Supervision, Inspection and Quarantine, Liu Pingjun, in Beijing this week.
More : timesofindia.indiatimes.com
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Tuesday, March 25th, 2008
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In a huge victory for the tobacco industry, the Florida Supreme Court on Thursday refused to reinstate a $US145 billion punitive damages award against major cigarette makers found liable for selling a dangerous product.
The decision lifted one of the biggest financial clouds over tobacco companies and sent their stocks up sharply.
It upheld the key part of a Florida appeals court ruling three years ago that overturned the punitive damages, one of the largest awards in a US product liability case.
The Florida Supreme Court said the award was “clearly excessive” and would “result in an unlawful crippling of the defendant companies.”
The ruling cleared one of the hurdles for Altria Group Incorporated’s plan to spin off Kraft Foods Incorporated.
But the Supreme Court also upheld key findings of the Miami trial court in the 12-year-old case known as Engle versus Liggett: among them, that cigarette smoking causes cancer, heart disease and other ailments, and that tobacco companies marketed “defective and unreasonably dangerous” products.
The Florida Supreme Court reinstated individual damage awards to two cancer patients - $US2.9 million to Mary Farnan and $US4 million to the estate of Angie Della Vecchia, who died in 1999.
But it upheld decertification of the class of plaintiffs, meaning smokers would have to sue individually, not as a group.
Individual lawsuits against tobacco companies are seen as far less likely to succeed than class actions.
Shares of Altria rose as high as $US79 afterwards. Shares of Reynolds American Incorporated hit a new high of $US120.50.
Carolina Group, the tracking stock for Loews Corporation’s Lorillard Tobacco Company, jumped to an all-time high of $US55.26.
More : tvnz.co.nz
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Tuesday, March 25th, 2008
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As a consumer correspondent, I often bring you stories of dangerous products and hazardous situations. This summer alone I’ve covered recalled beef, tainted toothpaste, skateboard injuries, barbecue grill fires, bacteria in beach waters and trampoline dangers.
And this week I would have brought you stories about laser printers emitting tiny particles that can lodge in your lungs and the presence of toxic lead in beloved toys like certain Dora the Explorer, Elmo and SpongeBob figures. Those last two stories were only pushed out of the headlines because of a more sudden and dramatic threat: collapsing bridges.
With all this doom and gloom, I often worry our viewers and readers will go numb and tune out safety advice. After all, that’s why parables like “The boy who cried wolf” and “Chicken Little” have enduring meaning. A constant clamor of alerts and warnings can have the effect of making no single message stand out. So I’m going to single one out for you: lead. More on that in a moment.
More : abcnews.go.com
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Tuesday, March 25th, 2008
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ROCKVILLE, Md. — ROCKVILLE, Md., Dec. 17 /PRNewswire/ — Consumers concerned about the quality and purity of vitamins and other dietary supplements can now look for the United States Pharmacopeia’s (USP) new DSVP certification mark on product packaging. The DSVP mark signifies that the supplement has undergone rigorous independent testing and verification from the same public health organization that has been setting medicine and dietary supplement standards since 1820.
(Photo: http://www.newscom.com/cgi-bin/prnh/20021217/DCTU011 )
“Today, USP is applying its scientific expertise and rigorous standards to the supplement industry,” explains John T. Fowler, chief operating officer at USP. “By selecting a supplement with USP’s DSVP certification mark, consumers will have greater confidence in the products they purchase.”
Dietary supplements, including vitamins, nutritional supplements and sports nutrition products, consumed by about 151 million Americans who spend about $17 billion annually. The U.S. Food and Drug Administration (FDA) regulates these supplements as foods, not medicines. USP is named in the law administered by the FDA as the nation’s official compendium for dietary supplement standards, although compliance with these standards is voluntary, and not enforced by the FDA.
USP’s Dietary Supplement Verification Program (DSVP) was first launched in November 2001 to help inform and safeguard the growing number of consumers who use dietary supplements. The program responds to the need to help assure the public that dietary supplement products contain the ingredients stated on the product label. If a product submitted to DSVP meets USP’s rigorous standards, it will be awarded the DSVP certification mark.
More : accessmylibrary.com
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Tuesday, March 25th, 2008
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Both the recent Institute of Medicine (IOM) report [1] and the article by Henningfield and Fagerstrom [2] in this issue of Tobacco Control consider the value of adding harm reduction products to the main public health strategies for dealing with tobacco use-prevention, cessation, and protection of non-smokers from tobacco smoke pollution. [3 4] Harm reducing products are those that lower total tobacco caused morbidity and mortality, even though these products might involve continued exposure to one or more tobacco related toxicants. The IOM committee developed a testing strategy to assess which products (tobacco or pharmaceutical) are truly harm reducing, along with surveillance and regulatory principles for the protection of public health. Henningfield and Fagerstrom [2] discussed the possible benefits from an uncontrolled harm reduction “intervention” in Sweden involving Snus (Swedish moist snuff) and to some extent nicotine replacement pharmaceuticals or medicinal nicotine (MN).
It will take years, if ever, before any battery of IOM-type tests will be in place. Given the probability of legal and political battles, the final form of testing and regulation may be far from adequate, leading to further decades of the promotion of ostensibly reduced risk products falsely reassuring tobacco users. Cigarette smoking remains the single leading preventable cause of death in most developed countries [5] and a major cause of current and future deaths in developing countries. [6] For health, non-smokers should never start smoking, and current smokers should become former smokers as soon as possible. Harm reduction, if done well, offers additional promise. Once it was hoped that lower tar cigarettes would have harm reducing properties and be good for the public’s health, [7] but, on current evidence, they have been a public health disaster. [8-11]
Strongly prefer harm reduction products with the largest effects to those with small effects
One harm reduction strategy is to alter cigarettes to try to reduce or eliminate toxic ingredients. Such altered cigarettes are of obvious interest to the cigarette industry. But there are serious practical challenges to assessing the impact of small changes. Scientifically, smaller effects are harder to identify than are larger effects. Reliably finding smaller effects requires more reliable measures and larger samples. [12] In other words, more expensive, longer term studies will be needed to determine, for example, if a product change has caused a 5% reduction in risk than an 80% reduction. The proposed IOM testing methods need to be applied to these new tobacco products before any recommendations can be made about novel, small change, reduced risk products; therefore, it will be years before it will be possible to assess with confidence the health risks of changes in cigarette formulations or other burned/heated tobacco products (for example, Eclipse, Accord, Advance).
More : accessmylibrary.com
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Tuesday, March 25th, 2008
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Republicans took control of Congress last January armed with a sweeping agenda to undo decades of regulation and in many cases tilt the laws toward industry and away from consumers, workers and even investors.
Why, then, has it been so hard to enact pro-business laws? To the dismay of many giant media and telephone companies this week, quarreling among House Republicans has jeopardized a bill that would overhaul decades of outdated regulations.
And that is hardly the only ambitious Republican initiative that has hit a roadblock. Bills that would slash environmental regulations, reduce the bargaining power of labor unions and make it harder to sue companies over defective products have all run into obstacles — both expected and unexpected:
*The House passed a measure in the spring that would block Federal agencies from issuing new regulations on environmental, health or safety issues without first documenting that the costs to business would be exceeded by the benefits, but Senate Republicans have been unable to bring the measure up for a vote.
*Tort legislation that would make it far more difficult for people to sue companies accused of making defective or dangerous products or to file malpractice suits against doctors has been stopped for now. The House and Senate both passed separate bills months ago, but the measures differ so much that the chambers have not even tried to reconcile them yet.
*The House has passed a bill that would require the Federal Government to compensate landowners if the value of their property declines as a result of new environmental rulings, but the Senate Judiciary Committee is still working on its version.
Some conservatives are plainly vexed. “To recall Shakespeare, there has been a lot of sound and fury, signifying nothing,” said Edward Hudgins, director of regulatory policy at the Cato Institute, a conservative research group in Washington.
So far this year, Congress has sent only one major business bill to President Clinton — a securities measure that would make it more difficult for investors to sue companies on charges of fraud and misrepresentation. President Clinton vetoed the measure on Tuesday, but the House overrode the veto on Wednesday, and the Senate followed suit today.
Despite unusual intramural bickering among Republicans, many lawmakers still predict that Congress will pass a telecommunications bill early next year.
More : query.nytimes.com
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Tuesday, March 25th, 2008
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LEAD: EARLY this century, the principal insecticide used on fruits and vegetables went by the elegant appellation ”Paris green.” Today’s chemists have a less appetizing name for the toxin - lead arsenate.
EARLY this century, the principal insecticide used on fruits and vegetables went by the elegant appellation ”Paris green.” Today’s chemists have a less appetizing name for the toxin - lead arsenate.
Banning outright such unquestionably dangerous products was the easy part of protecting health and the environment. As scientists learn about the delayed effects of more subtle poisons, regulators face much harder judgment calls.
For example, traces of the common solvent methylene chloride contaminate many sources of drinking water; how much of the suspected carcinogen does it take to make the water unsafe? The exhaust of garbage incinerators contains tiny amounts of dioxin, a highly toxic product of combustion; how much can a neighborhood reasonably tolerate in its air?
The science of risk assessment seeks to quantify such hazards. But it is laden with opinion as well as fact.
And, since environmentalists and industry beseige Government regulators with conflicting demands, politics also becomes an ingredient in the equations of risk.
In recent weeks, the Environmental Protection Agency demonstrated the controversial nature of this inexact science when it decided that several pollutants, including dioxin, methylene chloride, lead and arsenic are not as harmful as previously believed. In the new risk assessment for dioxin, the E.P.A. proposes to lower its safety threshold by a factor of 17.
No one really knows how harmful tiny amounts of dioxin can be. The precision implied by assigning numbers to risk is somewhat illusory, but regulators need exact figures on which to base rules.
The Dow Chemical Company, one of the companies involved in litigation over the defoliant Agent Orange, which contained traces of dioxin, applauded the new risk levels. ”Reconsidering any standard by updating the science is always a good idea,” said Kenneth L. Burgess, a company spokesman.
More : query.nytimes.com
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Tuesday, March 25th, 2008
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LEAD: The House Energy and Commerce Committee today approved a product liability bill that consumer advocates maintain constitutes an assault on the legal rights of victims of hazardous goods.
The House Energy and Commerce Committee today approved a product liability bill that consumer advocates maintain constitutes an assault on the legal rights of victims of hazardous goods.
The compromise measure, which is given virtually no chance of passing Congress this year, would establish uniform Federal liability standards for lawsuits over defective consumer goods and would pre-empt conflicting but generally stronger state laws.
A similar measure died on the Senate floor in 1986 after a filibuster led by Ernest F. Hollings, Democrat of South Carolina.
Business lobbyists say a Federal law would ease the growing burden of liability insurance costs and result in lower prices. Consumer groups say the bill will make it harder for victims to recover damages from manufacturers of unsafe products.
The bill, was approved 30 to 12 with the unanimous support of the committee’s 17 Republicans and a bare 13-member majority of its 25 Democrats. The measure now heads for further study by the Judiciary Committee, which shares jurisdiction and has traditionally favored trial lawyers in their opposition to such bills.
”We are getting ready for a fight in Judiciary,” said Representative Mike Synar, Democrat of Oklahoma, who had won the Energy and Commerce panel’s approval of several amendments favoring consumers.
Consumer lobbyists lost no time criticizing the bill and its supporters.
Joan Claybrook, president of Public Citizen, said: ”Since 1981, American industry has been battering away at Congress, trying to get a pre-emptive Federal product liability law passed that would give manufacturers and sellers greater opportunity to place dangerous products on the market with diminished liability to the people they injure. Today a majority of the committee brought that consumer nightmare a little closer to reality.”
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Tuesday, March 25th, 2008
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The effects produced by carbon-tetrachloride fire extinguishers similar to those blamed to a large degree for gassing 150 men and women on a Lexington Avenue subway train last week are described by A.C. Fieldner, S.H. Katz and S.P. Kinney in a technical paper issued by the United States Bureau of Mines.
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Tuesday, March 25th, 2008
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The Dingley Tariff bill is dead. For some time past we have expressed the opinion that the Republican leaders would be compelled to give up all hope of passing it. The proceedings in the caucus of the Republican Senators yesterday indicate that the bill will be dropped.
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Tuesday, March 25th, 2008
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Cigarette producers, faced with pressure from state attorneys general and public health groups, have dropped their demand for complete legal protection as a condition in the tobacco settlement talks, people involved in the negotiations said.
The change in the industry’s posture comes amid a swirl of activity involving the most contentious and complicated issue in the talks: how much legal protection, if any, should cigarette manufacturers receive in exchange for concessions on public health issues?
The tobacco industry had agreed to create a $300 billion fund to settle all smoking-related claims brought by individuals and states in exchange for complete legal protection. State attorneys general rejected that demand for blanket immunity and put forward suggestions that would allow smokers to file suits but limit the amount of money they could win.
Though agreement has not been reached on what such a system might look like, cigarette producers have dropped their insistence on blanket immunity as a condition for talks to move forward, said people involved in them.
”They have accepted that they cannot have a complete bar” to lawsuits, said one of those people.
A new round of the landmark negotiations is set to begin tomorrow in Dallas. At that time, state attorneys general and industry lawyers are expected to discuss the liability issues and present new proposals.
Though the industry concession keeps the negotiations alive, the issue of cigarette company liability involves thorny practical and legal questions. In the past, large funds were created to compensate the victims of dangerous products like asbestos and the Dalkon Shield, an intrauterine device that caused sterility. But those products, unlike cigarettes, were either banned or taken off the market. Negotiators in the tobacco talks must deal not only with current smoking-related claims, but also ones that will occur in the future.
Spokesmen for the Philip Morris Companies and the RJR Nabisco Corporation have declined to comment on any aspect of the negotiations. Richard Blumenthal, the Connecticut Attorney General, also declined to comment on any recent talks but said, ”My personal belief is that the industry will accept something short of blanket immunity.”
More : query.nytimes.com
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Tuesday, March 25th, 2008
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The Consumer Product Safety Commission announced yesterday that it had fined the Fisher-Price division of Mattel $1.1 million for failing to report defects in a line of toys, the largest fine the agency has ever leveled against a toymaker.
The agency said that Fisher-Price failed to report 116 fires and 1,800 incidents involving failures of the electrical system of its Power Wheels cars that young children ride.
Fisher-Price voluntarily recalled the toys in 1998, asking consumers to take them to service centers so the fuses could be upgraded and new electrical connectors could be installed.
But the safety commission said the recall began only after the government got in touch with Fisher-Price about problems with the electrical systems. Federal law requires companies to notify the government about safety risks.
The commission said that from 1984 to 1998 nine children were hurt in fires caused by Power Wheels and six more children were injured when the battery-powered vehicles, which travel up to 5 miles an hour, failed to stop. The fires caused by the toys also damaged 22 homes, resulting in $300,000 worth of property damage.
”When a company hides problems, it means dangerous products continued to be sold and people can be hurt,” said Ann W. Brown, the chairwoman of the commission. ”If they reported, we might have prevented some of these fires and injuries.”
Ms. Brown has been increasing the fines against companies for failing to report such defects. She wants companies to shed their reluctance to share reports of problems with safety regulators. In April, Dorel Industries was fined $1.75 million for failing to tell the government about safety problems with a variety of baby products made by its Cosco and Safety 1st divisions.
Mattel acquired the Power Wheels line when it bought Kransco in 1994 and then moved the toy to its Fisher-Price division the next year. The Power Wheels cars made from 1984 to 1998 were sold under nearly 100 different model names, for $70 to $300.
Fisher-Price has repaired about 580,000 of the Power Wheels cars sold from 1984 to 1998, and it estimates that three million of the toys remain in use. The company continues to make free repairs on the older models.
Laurie Oravec, a spokeswoman for Fisher-Price, said the company was paying the fine to put the Power Wheels recall behind it but was not admitting it did anything wrong. Ms. Oravec said the company did not believe it was required to report the 1,800 complaints to the commission.
”If we feel we have a product that is not performing the way we expect, we respond,” Ms. Oravec said. ”This is a case where we have a difference of opinion with the commission.”
Alan Schoem, director of the commission’s office of compliance, said the number of warranty claims alone was enough to tip off Fisher-Price about a problem.
More : query.nytimes.com
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Tuesday, March 25th, 2008
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BALTIMORE (August 17, 2007) - Attorney General Douglas F. Gansler today announced that Toys “R” Us has agreed to suspend the sale of its store-brand vinyl bibs that have been reported to contain significant levels of lead. The vinyl bibs in question were sold under the “Especially for Baby,” “Koala Baby,” and “Disney” baby labels. Gansler wrote to Toys “R” Us requesting that it stop selling the vinyl bibs and, following its receipt of that letter, the company alerted all of its stores to remove the vinyl bibs from their shelves.
Toys “R” Us has also agreed that consumers who purchased the bibs may return them to the stores where they were purchased and receive refunds. Toys “R” Us is also implementing a new policy regarding the amount of lead that is allowed in the products it sells. The new policy is stricter than the existing standards of the Consumer Product Safety Commission.
“I am pleased that Toys ‘R’ Us has quickly agreed to remove these potentially dangerous products from its store shelves,” said Gansler. “I encourage any consumers who purchased these vinyl bibs to stop using them at once and return them to Toys ‘R’ Us.”
Consumers who want more information concerning how to return the vinyl bibs for a refund should contact their local Toys “R” Us store.
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Tuesday, March 25th, 2008
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Mark McGwire’s little home run pill is about to be pulled off the shelves.
That’s the intent of a new bill sponsored by influential senators on both sides of the aisle, who introduced legislation late Thursday night that would prevent the over-the-counter sale of androstenedione and its muscle-building chemical cousins. The bill would also ban THG, the substance at the center of a growing scandal involving several elite athletes.
“These substances, called steroid precursors or pro-steroids, are one step removed from the substances [regulated] in the law,” Sen. Joseph Biden, D-Delaware, said on the Senate floor. “When ingested, they metabolize into testosterone or other illicit steroids. These are products which the United States Anti-Doping Agency, the group in charge of testing Olympic athletes for performance enhancing drugs, has called the ‘functional equivalent of steroids.’ ”
Biden was the driving force behind the effort in 1990 that led to anabolic steroids being made controlled substances. The new bill, the Anabolic Steroid Control Act of 2003, serves as acknowledgement that there were flaws in that original legislation, which discouraged doctors from prescribing steroids to athletes but stimulated the black market and encouraged scientists to devise powerful substances that were technically legal.
THG, a designer steroid undetectable by drug tests and kept secret until recently, is one of those substances. Although not sold in health stores — like andro is — the substance has the potential to become available over the counter once it becomes better known.
The bill is co-sponsored by Orrin Hatch, R-Utah, whose support is considered critical to the bill’s passage, Senate staffers familiar with the legislation told ESPN.com. Hatch was a leader in a successful 1994 effort to deregulate the nutritional supplement industry, which has spawned many of the ethically-suspect products used by athletes in recent years. Over the years, he has been perceived as a protector of the industry as calls have increased for greater government oversight of products such as andro.
Hatch has said the fault lies not with the legislation but with the Food and Drug Administration, which he believes should be more aggressive in determining that such substances fall outside the scope of existing law.
“I have been extremely frustrated by the lack of regulatory action on these performance-enhancing products,” Hatch said in a statement. “For years, I have asked the FDA to explain how these dangerous products could be marketed freely to our teens, but I’ve never received an adequate response. Our hand has been forced — we must act to ensure no more young athletes are placed at risk.”
The bill would not ban many of the more popular substances, such as ephedra and creatine, used by athletes to enhance performance.
The Senate bill gives renewed vitality to a similar bill introduced in January in the House of Representatives by Rep. John Sweeney, R-N.Y., and Tom Osborne, R-Neb., the former football coach at the University of Nebraska. Sweeney said Friday he became aware of the steroid precursor issue in the wake of McGwire’s andro revelations and his teenage son’s reaction to it.
“My son wanted to take andro because Mark McGwire did,” he said.
Andro, which is banned in the NFL and other sports but not in baseball, was used by McGwire during the 1998 season when he hit 70 home runs, breaking the single-season record owned by Roger Maris. Andro sales quadrupled after his admission, with teenagers making up many of those consumers.
At the time, McGwire dismissed public concerns about his use of andro, and discounted comparisons to anabolic steroids, because the pills were available over the counter.
McGwire could not be reached Friday for comment. His former agent, Robert Cohen, said he would relay an interview request from ESPN.com, but doubted the retired baseball player would respond.
More : sports.espn.go.com
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Tuesday, March 25th, 2008
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Federal, state, county and private agencies are collaborating in a campaign urging residents to repair or destroy products in their homes that can cause injuries or deaths.
Consumers continue to use potentially deadly products despite recall notices and warnings, said David Cheng, U.S. Consumer Product Safety Commission investigator, Honolulu Field Office.
The commission is kicking off its annual Recall Round-up campaign by working with other organizations to alert consumers to dangerous products and help them repair or destroy them.
A list of dangerous products is posted on the commission’s Web site, www.cpsc.gov.
The commission can take hazardous products off store shelves, but residents must be proactive to make their homes safe, Cheng said.
The agencies are joining with the Keiki Injury Prevention Coalition to hold a safety fair from 10 a.m. to 2 p.m. today at Toys-R-Us in Aiea.
Cheng said recalled products will be on display and many safety areas covered, including crib and home safety, car seats, water safety, poison prevention and anything to do with wheels, such as bicycles or skateboarding.
The Honolulu Fire Department’s Keiki Firehouse will be available for children to practice evacuation.
Cheng said the CPSC works regularly with the Fire Department to follow up on cases, such as the fire that destroyed a family home in Kalihi on Tuesday when a 3-year-old boy played with a lighter.
More : starbulletin.com
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Tuesday, March 25th, 2008
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A month ago, the US pharma giant Merck withdrew its best-selling drug rofecoxib (sold under the brand name Vioxx) after tests proved that it doubled the chances of heart attacks, and perhaps strokes. Many US buyers of the drug plan to become millionaires by suing Merck. Can Indians do the same?
In the US, lawyers mount class action suits on behalf of many sufferers, charging no fees but taking a share of any compensation awarded. Such suits against tobacco companies have won huge compensation for lawyers and smokers alike. Smokers have received millions, lawyers billions.
One website estimates that Merck may have to pay $5 billion, so users could get $2.5 million each. Vioxx may have killed over a lakh people, so relatives of those killed by heart attacks can sue too. Those Indians who imported Vioxx or purchased it while abroad can sign up with US lawyers advertising on the internet. An internet search through Goggle yields a plethora of entries from lawyers. One says that lawyers are paying $200 (Rs 9,000) to people just to sign up!
It goes on to say, “You will receive a document showing how an average person can benefit from this once-in-lifetime opportunity to become a millionaire. There are still places you can buy Vioxx after the recall, you can find them online. Merck is still 100 per cent responsible for any side-effect. The purchase is risk-free, as Merck has to pay you every penny you spend on Vioxx, including tax and shipping.”
Now, the biggest awards go to people who are crippled by disease, or dying. If you have used a dangerous drug and not suffered, your prospects are dimmer. But in recent times, litigants have managed to get compensation even without having contracted a fatal disease or suffered major impairment.
Few Indians would have imported Vioxx. Most would have purchased a locally-made version, manufactured by a dozen top companies (notably Ranbaxy, Unichem, Torrent and Lupin) under their own brand names.
Until the recent ban, the drug was widely used by arthritis patients and others needing anti-inflammatory pain-killers. For decades, such patients have used inexpensive drugs like ibuprofen.
But this drug causes bleeding in the stomach/intestines in some users. So drug companies developed a new class of drugs, cox-2 inhibitors, which cause no bleeding. One of these is rofecoxib. Ironically, other cox-2 inhibitors have not so far proved dangerous.
Rofecoxib in India had annual sales estimated at Rs 135 crore, so the number of users must have run into millions. Can they too sue? They have two options. One is to sue the Indian drug companies, the second to sue Merck. Few in India will try the first route.
Litigation here takes decades, and India does not have a tradition of class action suits. Still, if such a tradition is to ever develop, this could be a promising starting point.
What about suing Merck? The multinational will be outraged at the very thought. In its view, Indian companies have pirated its patent rights on Vioxx. However, patent laws of the US do not apply to India, and Indian companies have acted within Indian (and international) law in devising their know-how to make rofecoxib.
More : timesofindia.indiatimes.com
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Tuesday, March 25th, 2008
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LONDON: Anti-wrinkle treatments which are banned in the US are increasingly being used in the UK, a report has warned. Injections to smooth facial lines, called dermal fillers, are subject to strict rules in the US, but these regulations do not exist in Britain.
Consumer magazine Which? has warned that cosmetics companies are taking advantage of lenient British regulations to market dozens of anti-wrinkle treatments and UK consumers risk being used as “guinea pigs” for the “unproven and unregulated” treatments. This may be allowing potentially useless or even dangerous products to enter Britain.
More than 400,000 people in Britain have the non-surgical procedures every year. Up to 65 fillers are available in Europe compared to just seven approved for use in the US, Dermatologist Nick Lowe told Which? The government instead of strengthening regulations to clamp down on these filler as well as Botox have opted for self-regulation.
Concerns have been raised about hairdressers, dentists and beauticians giving injections. Some people have even held Botox parties.
Dr Peter Misra, from the National Hospital for Neurology and Neurosurgery, says: “In this atmosphere of ‘Botox parties’—where champagne-sipping socialites are injected with botulinum toxin—it is easy to forget that it is a potent neurotoxin and that its very long-term effects are still unknown.”
One of the products, Isolagen, is derived from the patient’s own cells so it is not classed as a medicine or medical product in Britain and does not need a licence.
But experts say that Isolagen is being hyped and claims that it rejuvenates the skin are “nonsense”. Thousands of patients have lodged complaints with the trading standards officers after paying up to £3,500 for non-effective injections. But the London-based arm of the US biotech firm disappeared after customers tried to get their money back. Isolagen was withdrawn in America in 1999 but was still introduced to Britain in 2002.
The firm has since used data gathered in Britain to support its pending licence application in America. The firm closed down its UK operations earlier this year. Isolagen Inc said the UK closure was due to “significant losses” and was not product or safety-related. It claimed that Isolagen had been cleared by the health regulator—even though it did not fall under any British rules.
A spokesman for the Department of Health said: “We have every confidence that self-regulation will result in improvements for people choosing non-surgical cosmetic treatments. Our plans for change are driven by the need to ensure that we only use statutory regulation where the reduction in risks to patient safety clearly outweigh the costs and burdens that regulation brings. We feel we can best protect people who wish to have these products by using other tools at our disposal.”
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Tuesday, January 22nd, 2008
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German food adulteration is the subject of a report received by the Bureau of Manufactures from Consul Brittain of Kehl
More : query.nytimes.com
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Tuesday, January 22nd, 2008
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The Senate voted overwhelmingly today to let pharmacists import prescription drugs from Canada and resell them in the United States, so consumers here could benefit from lower Canadian prices.
It was the second time in less than a year that the Senate had taken such a stand. But the proposal is contingent on a finding that the imports would pose no risk to public health, and the Bush administration has made clear that it will not issue such a finding.
The 62-to-28 vote to allow Canadian imports came as the Senate finished the first of two weeks of debate on a bipartisan bill to revamp Medicare and add coverage for prescription drugs.
Many members of Congress, especially those from states that border Canada, said their constituents were already traveling there to buy medicine at prices lower than those charged in the United States.
For years, these lawmakers have tried to ease the strict rules that prohibit most drug imports unless they have been authorized by the manufacturer. Many legislators have accused the drug industry of resisting imports to keep prices up.
”The U.S. consumer pays the highest prices in the world for prescription drugs,” said Senator Byron Dorgan, Democrat of North Dakota, who offered the plan on drug imports as an amendment to the Medicare bill.
”We should and must put some downward pressure on drug prices,” he said. ”I understand the pharmaceutical manufacturers do not like that. If I were in their position, I would certainly resist it as well.”
The House has previously voted for legislation like the Senate bill, which would allow pharmacists and wholesalers to import prescription drugs from Canada. Senator Dorgan said the safety risks were minimal.
A new report from the Congressional Research Service, done at the request of Representative Bernard Sanders, the Vermont independent, found that, ”The statutory requirements for approving and marketing pharmaceutical products in the United States and Canada are, in general, quite similar.”
Canada, like the United States, has rules and procedures to control the ”chain of custody” of prescription drugs, from factory to wholesaler to pharmacy, the report said.
But Dr. Mark B. McClellan, the head of the Food and Drug Administration, said his agency ”cannot guarantee the safety of Canadian drugs.”
Permitting imports from Canada would create ”a wide inlet for counterfeit drugs and other dangerous products that are potentially injurious to the public health,” Dr. McClellan, the food and drug commissioner, said in a letter to the Senate.
The Pharmaceutical Research and Manufacturers of America, the trade association for brand-name drug companies, also denounced Mr. Dorgan’s proposal.
”If importation were legal, Canada would become the easiest portal into the United States for the world’s terrorists and counterfeiters,” the association said in a document circulated on Capitol Hill.
Senator Thad Cochran, Republican of Mississippi, said that unsafe and adulterated drugs could be shipped from other countries, through Canada, to the United States. Senator Bill Frist of Tennessee, the majority leader, said such risks were particularly serious ”in this era of bioterrorism.”
Another Republican, Senator Rick Santorum of Pennsylvania, said that drug prices were lower in Canada because they were controlled by government agencies. The United States, he said, should not support that approach.
On Thursday, the Senate approved another amendment to the Medicare bill, which would speed the approval and marketing of low-cost generic versions of brand-name drugs.
After today’s vote, Senator Hillary Rodham Clinton, Democrat of New York, went to the Senate floor and denounced the underlying Medicare legislation. Mrs. Clinton said the bill would create a confusing, bureaucratic ”Medicare maze.” She made her point with a chart reminiscent of the one Republicans used in 1994 to ridicule the plan Mrs. Clinton had developed as first lady to guarantee health insurance for all Americans.
More : query.nytimes.com
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