Date: 3/31/2009
WASHINGTON (AP) — Preliminary studies of a blockbuster drug from Roche’s Genentech unit are strong enough to speed up its approval for brain cancer, federal cancer experts said Tuesday.
The company has asked the Food and Drug Administration to approve its blockbuster drug Avastin to treat patients with the deadliest form of brain tumor. The drug is already approved for patients with certain types of lung, breast and colon cancer.
The FDA’s panel of 10 outside experts unanimously voted that preliminary results in brain cancer patients warrant accelerated approval, according to an agency spokeswoman. The accelerated approval designation gives early market access to drugs that show promising early results. Companies must submit follow-up studies to stay on the market.
The FDA is not required to follow the advice of its panel, though it often does.
South San Francisco-based Genentech is now owned by drugmaker Roche, based in Basel, Switzerland.
Heading into the meeting, FDA’s drug reviewers said it was difficult to draw a clear connection between Avastin and tumor shrinkage seen in patient medical scans. Reviewers noted the difficulty of measuring tumor size via medical imaging.
But panelists were won over by two studies from Genentech showing between 20 and 25 percent of cancer patients responded to the treatment. The company also noted that “virtually no improvements have been made since the 1970s” in treatment for the cancer, known medically as recurring glioblastoma multiforme.
Avastin was Genentech’s top-selling product last year with revenue of $2.69 billion. However, sales growth has been slowing.
In the last quarter, U.S. sales of Avastin were $731 million, falling short of Wall Street forecasts for $740 million. Analysts said the drug is likely reaching a saturation point in the market and will need additional FDA approvals to continue growing.
Initially approved in 2004, Avastin was the first drug to fight cancer by choking off blood flow to tumors. Such “targeted therapies” were considered a significant advance beyond chemotherapy.
Copyright 2009 The Associated Press.
Richardson death revives debate on ski helmets
Date: 3/19/2009 11:14 PM
By MEGAN K. SCOTT
Associated Press Writer
NEW YORK (AP) — News that actress Natasha Richardson died of head injuries after falling on a ski slope has renewed debate over whether helmets should be mandatory for snowboarders and downhill skiers.
The 45-year-old actress was not wearing a helmet when she fell Monday at Mont Tremblant ski resort in Quebec. She died Wednesday in a New York hospital.
It’s unclear whether a helmet could have saved Richardson. But research shows wearing a helmet decreases the likelihood of having a head injury by 40 to 60 percent, said Dr. Robert Williams, associate professor of anesthesia and pediatrics at Fletcher Allen Health Care in Burlington, Vermont.
“There’s no downside at all to wearing a helmet,” he said.
In the United States, the National Ski Areas Association is not aware of any states that mandate helmets. But the association and its member resorts promote their use, and a growing number of skiers and snowboarders choose to wear them.
According to the group, nearly half of U.S. skiers and snowboarders wore helmets in the past two years, up from about 25 percent five years earlier. Sales of helmets have grown at a rate of about 9 percent each year since 2005-2006, according to SnowSports Industries America.
Quebec officials said Thursday that they are considering making helmets mandatory on ski slopes following Richardson’s accident. Emergency room doctors had been lobbying for the requirement, and Richardson’s death added impetus to the plans, said Jean-Pascal Bernier, a spokesman for the sports minister.
“By no means will a helmet save you 100 percent but it’s definitely a step in the right direction to try to prevent brain damage or something like that,” said Valerie Powell of the Canada Safety Council.
But the National Ski Areas Association, based in Lakewood, Colorado, stops short of calling for legislation.
The increase in helmet usage has not reduced the overall number of ski fatalities; more than half of the people involved in fatal accidents last season were wearing helmets at the time of the incident, according to information gathered by the group.
And ski and snowboarding-related deaths are relatively rare. During the 2004-2005 season, 45 fatalities occurred out of the 56.9 million skier/snowboarder days reported for the season, according to NSAA.
Helmets may be effective at preventing minor injuries, but they have not been shown to reduce fatalities, said Jasper Shealy, a professor emeritus at the Rochester Institute of Technology who has been studying skiing and snowboarding since 1970.
He encourages people to wear helmets, although he suspects they may give people a false sense of security to engage in risky stunts. Helmets work better at slow speeds, he said, when they can protect against injuries caused by collisions with solid objects.
Ski operators are among the most vocal opponents to mandated helmet use.
Alexis Boyer of the Quebec Ski Areas Association said 90 percent of youngsters under 12 already use helmets, but making that law would put operators in the position of having to police their guests, many of whom come from outside the province and country and may not be aware of the requirements.
Still, people tend to change their behavior as a result of high-profile deaths.
Andrea Fereshteh, 29, a writer at Duke University, said she started wearing a helmet after the ski-related deaths of Sonny Bono and Michael Kennedy. Both crashed into trees.
“It just became much more publicized about the need for helmets,” she said.
Richardson’s death is likely to hit home for skiers because she was on a beginner slope when she fell. Resort officials say she seemed fine immediately afterward and even refused to see a doctor but that she began complaining of a headache about an hour later and was rushed to hospital.
Scott Kerschbaumer, a former ski instructor who has never worn a helmet, considered Bono’s and Kennedy’s skiing deaths to be the result of high-speed, somewhat reckless behavior.
Richardson shows “that the most serious of injuries and even death can result from the most innocuous of falls while skiing.”
Kerschbaumer said he hadn’t wanted to wear a helmet because of vanity and comfort, but will now purchase one for himself and his 6-year-old son.
As a beginner skier, Latoicha Phillips Givens, 35, an attorney in Atlanta, thought she was safe skiing without one. She said she certainly is going to wear one now.
But Bill Douglass, 37, a social media strategist in New York City, said he doesn’t want to see people overreact.
“I think wearing a helmet when skiing is going too far,” he said. “Better to encourage people to focus on smarter safety measures like taking classes, learning how to stop properly, that kind of thing.”
___
Associated Press Writer Rob Gillies in Toronto contributed to this report.
Copyright 2009 The Associated Press.
By MEGAN K. SCOTT
Associated Press Writer
NEW YORK (AP) — News that actress Natasha Richardson died of head injuries after falling on a ski slope has renewed debate over whether helmets should be mandatory for snowboarders and downhill skiers.
The 45-year-old actress was not wearing a helmet when she fell Monday at Mont Tremblant ski resort in Quebec. She died Wednesday in a New York hospital.
It’s unclear whether a helmet could have saved Richardson. But research shows wearing a helmet decreases the likelihood of having a head injury by 40 to 60 percent, said Dr. Robert Williams, associate professor of anesthesia and pediatrics at Fletcher Allen Health Care in Burlington, Vermont.
“There’s no downside at all to wearing a helmet,” he said.
In the United States, the National Ski Areas Association is not aware of any states that mandate helmets. But the association and its member resorts promote their use, and a growing number of skiers and snowboarders choose to wear them.
According to the group, nearly half of U.S. skiers and snowboarders wore helmets in the past two years, up from about 25 percent five years earlier. Sales of helmets have grown at a rate of about 9 percent each year since 2005-2006, according to SnowSports Industries America.
Quebec officials said Thursday that they are considering making helmets mandatory on ski slopes following Richardson’s accident. Emergency room doctors had been lobbying for the requirement, and Richardson’s death added impetus to the plans, said Jean-Pascal Bernier, a spokesman for the sports minister.
“By no means will a helmet save you 100 percent but it’s definitely a step in the right direction to try to prevent brain damage or something like that,” said Valerie Powell of the Canada Safety Council.
But the National Ski Areas Association, based in Lakewood, Colorado, stops short of calling for legislation.
The increase in helmet usage has not reduced the overall number of ski fatalities; more than half of the people involved in fatal accidents last season were wearing helmets at the time of the incident, according to information gathered by the group.
And ski and snowboarding-related deaths are relatively rare. During the 2004-2005 season, 45 fatalities occurred out of the 56.9 million skier/snowboarder days reported for the season, according to NSAA.
Helmets may be effective at preventing minor injuries, but they have not been shown to reduce fatalities, said Jasper Shealy, a professor emeritus at the Rochester Institute of Technology who has been studying skiing and snowboarding since 1970.
He encourages people to wear helmets, although he suspects they may give people a false sense of security to engage in risky stunts. Helmets work better at slow speeds, he said, when they can protect against injuries caused by collisions with solid objects.
Ski operators are among the most vocal opponents to mandated helmet use.
Alexis Boyer of the Quebec Ski Areas Association said 90 percent of youngsters under 12 already use helmets, but making that law would put operators in the position of having to police their guests, many of whom come from outside the province and country and may not be aware of the requirements.
Still, people tend to change their behavior as a result of high-profile deaths.
Andrea Fereshteh, 29, a writer at Duke University, said she started wearing a helmet after the ski-related deaths of Sonny Bono and Michael Kennedy. Both crashed into trees.
“It just became much more publicized about the need for helmets,” she said.
Richardson’s death is likely to hit home for skiers because she was on a beginner slope when she fell. Resort officials say she seemed fine immediately afterward and even refused to see a doctor but that she began complaining of a headache about an hour later and was rushed to hospital.
Scott Kerschbaumer, a former ski instructor who has never worn a helmet, considered Bono’s and Kennedy’s skiing deaths to be the result of high-speed, somewhat reckless behavior.
Richardson shows “that the most serious of injuries and even death can result from the most innocuous of falls while skiing.”
Kerschbaumer said he hadn’t wanted to wear a helmet because of vanity and comfort, but will now purchase one for himself and his 6-year-old son.
As a beginner skier, Latoicha Phillips Givens, 35, an attorney in Atlanta, thought she was safe skiing without one. She said she certainly is going to wear one now.
But Bill Douglass, 37, a social media strategist in New York City, said he doesn’t want to see people overreact.
“I think wearing a helmet when skiing is going too far,” he said. “Better to encourage people to focus on smarter safety measures like taking classes, learning how to stop properly, that kind of thing.”
___
Associated Press Writer Rob Gillies in Toronto contributed to this report.
Copyright 2009 The Associated Press.
Lead raises questions about children’s books
Date: 3/18/2009
By LEE LOGAN
Associated Press Writer
JEFFERSON CITY, Mo. (AP) — Could a vintage, dog-eared copy of “The Cat in the Hat” or “Where the Wild Things Are” be hazardous to your children?
Probably not, according to the nation’s premier medical sleuths, the Centers for Disease Control and Prevention.
But a new federal law banning more than minute levels of lead in most products intended for children 12 or younger — and a federal agency’s interpretation of the law — prompted at least two libraries last month to pull children’s books printed before 1986 from their shelves.
Lead poisoning has been linked to irreversible learning disabilities and behavioral problems, and lead was present in printer’s ink until a growing body of regulations banned it in 1986. The federal law, which took effect Feb. 10, was passed last summer after a string of recalls of toys.
The Consumer Product Safety Commission has interpreted the law to include books but has neither concluded that older books could be hazardous to children nor made any recommendations to libraries about quarantining such tomes, agency chief of staff Joe Martyak said Tuesday.
Still, the agency’s interpretation itself has been labeled alarmist by some librarians.
“We’re talking about tens of millions of copies of children’s books that are perfectly safe. I wish a reasonable, rational person would just say, ‘This is stupid. What are we doing?'” said Emily Sheketoff, executive director of the American Library Association’s Washington office.
A CPSC spokesman told The Associated Press in a recent interview that until more testing is done, the nation’s more than 116,000 public and school libraries should take steps to ensure that children are kept away from books printed before 1986.
After the spokesman’s comments appeared Tuesday in an AP story, Martyak said the spokesman “misspoke” about the agency’s stance on older books and younger children.
“We’re not urging libraries to take them off the shelves,” Martyak said. “It’s true the CPSC is investigating whether the ink contains unsafe levels of lead in children’s books printed before 1986.”
Jay Dempsey, a health communications specialist at the CDC, said lead-based ink in children’s books poses little danger.
“If that child were to actually start mouthing the book — as some children put everything in their mouths — that’s where the concern would be,” Dempsey said. “But on a scale of one to 10, this is like a 0.5 level of concern.”
The publishing and printing industries set up a Web site for book publishers last December to post the results of studies measuring the lead in books and their components, such as ink and paper. Those results show lead levels that were often undetectable and consistently below not only the new federal threshold, but the more stringent limit that goes into effect in August 2011.
Those findings were cited in a letter from the Association of American Publishers to the CPSC.
The American Library Association said it has no estimate of how many children’s books printed before 1986 are in circulation. But typically, libraries don’t have many, because youngsters are hard on books, librarians said.
“Frankly, most of our books have been well-used and well-appreciated,” said Rhoda Goldberg, director of the Harris County Public Library system in Houston. “They don’t last 24 years.”
Also, the lead is contained only in the type, not in the illustrations, according to Allan Adler, vice president for legal and governmental affairs for the Association of American Publishers.
Sheketoff said she heard of just two libraries that started to restrict access to children’s books last month amid publicity about the new law. One roped off the children’s section; the other covered children’s books with a tarp. Both libraries, which she declined to identify, stopped after being contacted by the association, she said.
“Communities would have a stroke if public libraries started throwing out hundreds and hundreds of books just because they came out before a certain copyright date,” said Margaret Todd, librarian for the Los Angeles County system, which has 89 branches and about 3 million children’s books. Todd said she expects the commission to develop reasonable standards that protect children.
Nathan Brown, a lawyer for the library association, said libraries should not even be subject to the law. He argued that Congress never wanted to regulate books and that libraries do not sell books and thus are not subject to the consumer products law.
___
Associated Press Writer David A. Lieb contributed to this report.
___
On the Net:
Safety Commission: http://www.cpsc.gov/index.html
Publishers Association study: http://www.rrd.com/cpsia
Copyright 2009 The Associated Press.
By LEE LOGAN
Associated Press Writer
JEFFERSON CITY, Mo. (AP) — Could a vintage, dog-eared copy of “The Cat in the Hat” or “Where the Wild Things Are” be hazardous to your children?
Probably not, according to the nation’s premier medical sleuths, the Centers for Disease Control and Prevention.
But a new federal law banning more than minute levels of lead in most products intended for children 12 or younger — and a federal agency’s interpretation of the law — prompted at least two libraries last month to pull children’s books printed before 1986 from their shelves.
Lead poisoning has been linked to irreversible learning disabilities and behavioral problems, and lead was present in printer’s ink until a growing body of regulations banned it in 1986. The federal law, which took effect Feb. 10, was passed last summer after a string of recalls of toys.
The Consumer Product Safety Commission has interpreted the law to include books but has neither concluded that older books could be hazardous to children nor made any recommendations to libraries about quarantining such tomes, agency chief of staff Joe Martyak said Tuesday.
Still, the agency’s interpretation itself has been labeled alarmist by some librarians.
“We’re talking about tens of millions of copies of children’s books that are perfectly safe. I wish a reasonable, rational person would just say, ‘This is stupid. What are we doing?'” said Emily Sheketoff, executive director of the American Library Association’s Washington office.
A CPSC spokesman told The Associated Press in a recent interview that until more testing is done, the nation’s more than 116,000 public and school libraries should take steps to ensure that children are kept away from books printed before 1986.
After the spokesman’s comments appeared Tuesday in an AP story, Martyak said the spokesman “misspoke” about the agency’s stance on older books and younger children.
“We’re not urging libraries to take them off the shelves,” Martyak said. “It’s true the CPSC is investigating whether the ink contains unsafe levels of lead in children’s books printed before 1986.”
Jay Dempsey, a health communications specialist at the CDC, said lead-based ink in children’s books poses little danger.
“If that child were to actually start mouthing the book — as some children put everything in their mouths — that’s where the concern would be,” Dempsey said. “But on a scale of one to 10, this is like a 0.5 level of concern.”
The publishing and printing industries set up a Web site for book publishers last December to post the results of studies measuring the lead in books and their components, such as ink and paper. Those results show lead levels that were often undetectable and consistently below not only the new federal threshold, but the more stringent limit that goes into effect in August 2011.
Those findings were cited in a letter from the Association of American Publishers to the CPSC.
The American Library Association said it has no estimate of how many children’s books printed before 1986 are in circulation. But typically, libraries don’t have many, because youngsters are hard on books, librarians said.
“Frankly, most of our books have been well-used and well-appreciated,” said Rhoda Goldberg, director of the Harris County Public Library system in Houston. “They don’t last 24 years.”
Also, the lead is contained only in the type, not in the illustrations, according to Allan Adler, vice president for legal and governmental affairs for the Association of American Publishers.
Sheketoff said she heard of just two libraries that started to restrict access to children’s books last month amid publicity about the new law. One roped off the children’s section; the other covered children’s books with a tarp. Both libraries, which she declined to identify, stopped after being contacted by the association, she said.
“Communities would have a stroke if public libraries started throwing out hundreds and hundreds of books just because they came out before a certain copyright date,” said Margaret Todd, librarian for the Los Angeles County system, which has 89 branches and about 3 million children’s books. Todd said she expects the commission to develop reasonable standards that protect children.
Nathan Brown, a lawyer for the library association, said libraries should not even be subject to the law. He argued that Congress never wanted to regulate books and that libraries do not sell books and thus are not subject to the consumer products law.
___
Associated Press Writer David A. Lieb contributed to this report.
___
On the Net:
Safety Commission: http://www.cpsc.gov/index.html
Publishers Association study: http://www.rrd.com/cpsia
Copyright 2009 The Associated Press.
After football player death, Ky. seeks safety plan
Date: 3/13/2009 6:50 PM
By BRUCE SCHREINER
Associated Press Writer
FRANKFORT, Ky. (AP) — Kentucky House lawmakers unanimously passed a bill Friday to require the state’s high school coaches to complete first aid and sports safety training on athlete heat stroke and cold emergencies, a measure inspired by the death of a teenage football player at a sweltering summer practice.
National experts gave mixed reviews to Kentucky’s sports safety measure, which if signed into law by Gov. Steve Beshear would require every high school coaching staff to have at least one member with safety training roaming practice fields and game sidelines by the start of the next school year.
The measure, spurred on by the death of high school lineman Max Gilpin, cleared the House 93-0 Friday and the Senate 38-0 a day earlier.
“The intent is to give the coaches the tools they need to keep our students safe,” Democratic Rep. Joni Jenkins said after sponsoring the bill.
She said it was designed to give coaches greater know-how in averting any emergency and better skills to deal with one before trained medical help can be found.
“They’ll be able to recognize dangerous situations before they become tragic. And they’ll know to act immediately,” she said.
Beshear spokesman Jay Blanton said the governor will review the measure before deciding whether to sign it.
Gilpin, a sophomore at Pleasure Ridge Park High School in Louisville, died after collapsing in practice last August and arriving at a hospital with a 107-degree temperature, authorities said.
The 15-year-old’s coach, David Jason Stinson, has pleaded not guilty to reckless homicide in an unusual case of a coach being charged criminally with a player’s death.
Gilpin’s death certificate showed he died of septic shock, multiple organ failure and complications from heat stroke, three days after working out for two to three hours in temperatures that reportedly felt like 94 degrees. No autopsy was conducted.
The case alarmed Kentucky residents and sent shock waves through high school athletic programs nationwide after a rash of player deaths reported in high school programs around the country last year.
From 1995 through 2008, there were 39 heat stroke cases in all levels of football that resulted in death, according to a report compiled by Frederick Mueller at the University of North Carolina for the American Football Coaches Association in February 2009.
Mueller, a professor specializing in sport administration, said Friday that Kentucky’s proposal was a “good idea,” and said more states are now taking a closer look at athlete safety.
But Douglas J. Casa, director of athletic training education at the University of Connecticut, said that the concept is good but the bill doesn’t go far enough. “No course is going to properly prepare them (coaches) to deal with the emergencies they’re going to have to deal with on the field,” he said.
Casa said schools offering sports programs should be required to hire athletic trainers — something some say will be difficult because it requires more money.
Kentucky schools are not required to have certified athletic trainers, though the Kentucky High School Athletic Association strongly encourages them to hire trainers. The association issued a statement lauding the bill for putting an increased spotlight on safety and ensuring any risks to players are minimized.
Copyright 2009 The Associated Press.
By BRUCE SCHREINER
Associated Press Writer
FRANKFORT, Ky. (AP) — Kentucky House lawmakers unanimously passed a bill Friday to require the state’s high school coaches to complete first aid and sports safety training on athlete heat stroke and cold emergencies, a measure inspired by the death of a teenage football player at a sweltering summer practice.
National experts gave mixed reviews to Kentucky’s sports safety measure, which if signed into law by Gov. Steve Beshear would require every high school coaching staff to have at least one member with safety training roaming practice fields and game sidelines by the start of the next school year.
The measure, spurred on by the death of high school lineman Max Gilpin, cleared the House 93-0 Friday and the Senate 38-0 a day earlier.
“The intent is to give the coaches the tools they need to keep our students safe,” Democratic Rep. Joni Jenkins said after sponsoring the bill.
She said it was designed to give coaches greater know-how in averting any emergency and better skills to deal with one before trained medical help can be found.
“They’ll be able to recognize dangerous situations before they become tragic. And they’ll know to act immediately,” she said.
Beshear spokesman Jay Blanton said the governor will review the measure before deciding whether to sign it.
Gilpin, a sophomore at Pleasure Ridge Park High School in Louisville, died after collapsing in practice last August and arriving at a hospital with a 107-degree temperature, authorities said.
The 15-year-old’s coach, David Jason Stinson, has pleaded not guilty to reckless homicide in an unusual case of a coach being charged criminally with a player’s death.
Gilpin’s death certificate showed he died of septic shock, multiple organ failure and complications from heat stroke, three days after working out for two to three hours in temperatures that reportedly felt like 94 degrees. No autopsy was conducted.
The case alarmed Kentucky residents and sent shock waves through high school athletic programs nationwide after a rash of player deaths reported in high school programs around the country last year.
From 1995 through 2008, there were 39 heat stroke cases in all levels of football that resulted in death, according to a report compiled by Frederick Mueller at the University of North Carolina for the American Football Coaches Association in February 2009.
Mueller, a professor specializing in sport administration, said Friday that Kentucky’s proposal was a “good idea,” and said more states are now taking a closer look at athlete safety.
But Douglas J. Casa, director of athletic training education at the University of Connecticut, said that the concept is good but the bill doesn’t go far enough. “No course is going to properly prepare them (coaches) to deal with the emergencies they’re going to have to deal with on the field,” he said.
Casa said schools offering sports programs should be required to hire athletic trainers — something some say will be difficult because it requires more money.
Kentucky schools are not required to have certified athletic trainers, though the Kentucky High School Athletic Association strongly encourages them to hire trainers. The association issued a statement lauding the bill for putting an increased spotlight on safety and ensuring any risks to players are minimized.
Copyright 2009 The Associated Press.