FDA Touts Increased Drug Approvals, Near Record for a Decade

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Number of new drugs approved by the U.S. Food and Drug Administration in the year ending in September 2011 — an approval rate that has been exceeded just once in the previous decade. The FDA said it was the first in the world to approve 24 of the drugs, including many that were "truly medically important," according to FDA Commissioner Dr. Margaret Hamburg, such as the first drug for lupus in 50 years, the first drug for Hodgkin's lymphoma in 30 years, and the first drug to prolong survival in late-stage melanoma patients. The FDA pointed to its increase in approvals in part to counter increasing criticism that the agency's overly stringent approval process is hindering American innovation and competitiveness. [via The New York Times]

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Kids' ER concussion visits up 60 pct over decade

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ATLANTA (AP) — The number of athletic children going to hospitals with concussions is up 60 percent in the past decade, a finding that is likely due to parents and coaches being more careful about treating head injuries, according to a new federal study.

"It's a good increase, if that makes any sense," said Steve Marshall, interim director of the University of North Carolina's Injury Prevention and Research Center.

"These injuries were always there. It's not that there are more injuries now. It's just that now people are getting treatment that they weren't getting before," said Marshall, who was not involved in the new research.

Bicycling and football were the leading reasons for the kids' brain injuries, but health officials said that could be at least partly related to the popularity of those activities. For example, it's possible many more kids bike, so a larger number of bike-related injuries would be expected.

The Centers for Disease Control and Prevention study is based on a survey of 66 hospital emergency departments that was designed to be nationally representative. The CDC looked at non-fatal data for the years 2001 through 2009 for kids and teens ages 19 and younger.

The agency looked at traumatic brain injuries, a category of injuries that mostly counts concussions but also includes skull fractures and bleeding in the brain.

The estimated numbers of kids coming into ERs with these brain injuries rose dramatically, about 153,000 in 2001 to nearly 250,000 in 2009. The rate also rose, also by about 60 percent.

However, there was not a significant increase in the rate of kids who were immediately admitted to the main hospital for further treatment. That suggests that more so than in the past, more coaches and parents have been bringing kids to the ER with mild concussions and blows to the head, said Dr. Julie Gilchrist, a CDC epidemiologist who led the study.

That's probably due to more awareness of the formerly under-appreciated long-term hazards of concussions, she added.

In 2003, the CDC started a "Heads Up" youth concussion awareness campaign targeting doctors. Since then, the agency has expanded the focus to coaches and school officials.

That effort was bolstered by a series of studies that began to appear around 2005 that showed damage in the brains of former National Football League players. Media coverage of such studies has intensified in the past four years, too, with reports focusing not only on football players but also the actress Natasha Richardson, who died in 2009 from a brain injury from a skiing accident.

At the University of Rochester Medical Center in New York state, nearly all of the kids who come in with concussions are brought in by their parents. Such visits have been increasing, and many parents seem to have become aware of the danger of concussions by reports on television, said Dr. Jeffrey Bazarian, an emergency physician there.

"I think the TV specials on this have them spooked," he said.

Parents may also be motivated by recently passed state laws in New York and elsewhere that require student athletes with concussion symptoms to be cleared by a medical professional before being allowed to participate in sports, Bazarian said.

In 2011, bills were introduced in at least 39 states that were aimed at better management of traumatic brain injuries, and most targeted sports-related concussions in youths, according to the National Conference of State Legislatures.

Other highlights from the CDC study:

—About 70 percent of the ER visits were by boys.

—About 70 percent were kids ages 10 to 19.

—Younger kids commonly got their injuries on the playground or from biking. Older kids were more likely to get them from sports, with football being the leading source for brain injuries in older boys, and biking, soccer and basketball for older girls.

—The estimated number of traumatic brain injuries in athletic kids held about steady from 2001 to 2004, but then shot up afterward, rising most dramatically from 2008 to 2009.

—Overall, about 15 percent of such traumatic brain injuries each year was from bicycling, on average, making that the leading cause. Football was a close second.

Health officials have long advocated the use of bicycle helmets as a way to reduce the severity of head injuries, but helmet use dropped after the early 1990s and has been holding at a fairly low rate for more than a decade. About 85 percent of youths say they rarely or never wear a bicycle helmet, according to one government survey.

___

Online:

CDC report: http://www.cdc.gov/mmwr

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Kids' ER concussion visits up 60 pct over decade

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ATLANTA (AP) — The number of athletic children going to hospitals with concussions is up 60 percent in the past decade, a finding that is likely due to parents and coaches being more careful about getting head injuries treated, according to a new federal study.

"It's a good increase, if that makes any sense," said Steven Marshall, interim director of the University of North Carolina's Injury Prevention and Research Center.

"These injuries were always there. It's not that there are more injuries now. It's just that now people are getting treatment that they weren't getting before," said Marshall, who was not involved in the new research.

Bicycling and football were the leading reasons for the kids' brain injuries, but health officials said that could be at least partly related to the popularity of those activities. For example, it's possible many more kids bike, so a larger number of bike-related injuries would be expected.

The Centers for Disease Control and Prevention study is based on a survey of 66 hospital emergency departments that was designed to be nationally representative. The CDC looked at non-fatal data for the years 2001 through 2009 for kids and teens ages 19 and younger.

The agency looked at traumatic brain injuries, a category of injuries that mostly counts concussions but also includes skull fractures and bleeding in the brain.

The estimated numbers of kids coming into ERs with these brain injuries rose dramatically, about 153,000 in 2001 to nearly 250,000 in 2009. The rate also rose, also by about 60 percent.

However, there was not a significant increase in the rate of kids who were immediately admitted into the main hospital for further treatment. That suggests that more so that in the past, more coaches and parents have been bringing kids to the ER with mild concussions and blows to the head, said Dr. Julie Gilchrist, a CDC epidemiologist who led the study.

That's probably due to more awareness of the formerly under-appreciated long-term hazards of concussions, she added.

In 2003, the CDC started a "Heads Up" youth concussion awareness campaign targeting doctors. Since then, the agency has expanded the focus to coaches and school officials.

That effort was bolstered by series of studies that began to appear around 2005 that showed damage in the brains of former National Football League players.

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Cantaloupe outbreak is deadliest in a decade

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Owner Eric Jensen examines cantaloupe on the Jensen Farms near Holly, Colo., on Wednesday, Sept. 28, 2011. Federal health officials said Wednesday more illnesses and possibly more deaths may be linked to an outbreak of listeria in cantaloupe in coming weeks. (AP Photo/Ed Andrieski) Owner Eric Jensen examines cantaloupe on the Jensen Farms near Holly, Colo., on Wednesday, Sept. 28, 2011. Federal health officials said Wednesday more illnesses and possibly more deaths may be linked to an outbreak of listeria in cantaloupe in coming weeks. (AP Photo/Ed Andrieski) A sign leading to the Jensen Farms near Holly, Colo., is pictured on Wednesday, Sept. 28, 2011. Federal health officials said Wednesday more illnesses and possibly more deaths may be linked to an outbreak of listeria in cantaloupe in coming weeks. (AP Photo/Ed Andrieski) Workers use a tractor to remove plastic from a field of rotting cantaloupe on the Jensen Farms near Holly, Colo., on Wednesday, Sept. 28, 2011. The Food and Drug Administration has recalled 300,000 cases of cantaloupe grown on the Jensen Farms after connecting it with a listeria out break. (AP Photo/Ed Andrieski) Cantaloupes rot in the afternoon heat on a field on the Jensen Farms near Holly, Colo., on Wednesday, Sept. 28, 2011. Federal health officials said Wednesday more illnesses and possibly more deaths may be linked to an outbreak of listeria in cantaloupe in coming weeks. (AP Photo/Ed Andrieski)eval("var currentItemd57851005a80479aaeeb90a12c70b9ff = 1;");eval("var nextd57851005a80479aaeeb90a12c70b9ff = 0;");eval("var previousd57851005a80479aaeeb90a12c70b9ff = 0;"); WASHINGTON (AP) — Health officials say as many as 16 people have died from possible listeria illnesses traced to Colorado cantaloupes, the deadliest food outbreak in more than a decade.

The Centers for Disease Control and Prevention said Tuesday that 72 illnesses, including 13 deaths, are linked to the tainted fruit. State and local officials say they are investigating three additional deaths that may be connected.

The death toll released by the CDC Tuesday — including newly confirmed deaths in Kansas, Missouri, Nebraska and Texas — surpassed the number of deaths linked to an outbreak of salmonella in peanuts almost three years ago. Nine people died in that outbreak.

The CDC said Tuesday that they have confirmed two deaths in Texas and one death each in in Kansas, Missouri and Nebraska. Last week the CDC reported two deaths in Colorado, four deaths in New Mexico, one in Oklahoma and one in Maryland.

New Mexico officials said Tuesday they are investigating a fifth death, while health authorities in Kansas and Wyoming said they too are investigating additional deaths possibly linked to the tainted fruit.

Listeria is more deadly than well-known pathogens like salmonella and E. coli, though those outbreaks generally cause many more illnesses. Twenty-one people died in an outbreak of listeria poisoning in 1998 traced to contaminated hot dogs and possibly deli meats made by Bil Mar Foods, a subsidiary of Sara Lee Corp. Another large listeria outbreak in 1985 killed 52 people and was linked to Mexican-style soft cheese.

Listeria generally only sickens the elderly, pregnant women and others with compromised immune systems. The CDC said the median age of those sickened is 78 and that one in five who contract the disease can die.

Dr. Robert Tauxe of the CDC says the number of illnesses and deaths will probably grow in coming weeks because the symptoms of listeria don't always show up right away. It can take four weeks or more for a person to fall ill after eating food contaminated with listeria.

"That long incubation period is a real problem," Tauxe said. "People who ate a contaminated food two weeks ago or even a week ago could still be falling sick weeks later."

CDC reported the 72 illnesses and deaths in 18 states. Cases of listeria were reported in California, Colorado, Florida, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, Texas, Virginia, West Virginia, Wisconsin, and Wyoming. The most illnesses were reported in Colorado, which has seen 15 sickened. Fourteen illnesses were reported in Texas, 10 in New Mexico and eight in Oklahoma.

The outbreak has been traced to Jensen Farms in Holly, Colo., which recalled the tainted cantaloupes earlier this month. The Food and Drug Administration said state health officials had found listeria in cantaloupes taken from grocery stores in the state and from a victim's home that were grown at Jensen Farms. Matching strains of the disease were found on equipment and cantaloupe samples at Jensen Farms' packing facility in Granada, Colo.

FDA, which investigates the cause of foodborne outbreaks, has not released any additional details on how the contamination may have happened. The agency says its investigation is ongoing.

The Rocky Ford-brand cantaloupes from Jensen Farms were shipped from July 29 through Sept. 10 to Arkansas, Arizona, California, Colorado, Idaho, Illinois, Kansas, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, and Wyoming.

The recalled cantaloupe may be labeled "Colorado Grown," ''Distributed by Frontera Produce," ''Jensenfarms.com" or "Sweet Rocky Fords." Not all of the recalled cantaloupes are labeled with a sticker, the FDA said.

Unlike many pathogens, listeria bacteria can grow at room temperatures and even refrigerator temperatures. The FDA and CDC recommend anyone who may have one of the contaminated cantaloupes throw it out immediately and clean and sanitize any surfaces it may have touched.

About 800 cases of listeria are found in the United States each year, according to CDC, and there usually are three or four outbreaks. Most of these are traced to deli meat and soft cheeses, where listeria is most common.

Produce has rarely been the culprit, but federal investigators say they have seen more produce-related listeria illnesses in the past two years. It was found in sprouts in 2009 and celery in 2010.

While most healthy adults can consume listeria with no ill effects, it can kill the elderly and those with compromised immune systems. It is also dangerous to pregnant women because it easily passes through to the fetus. Dr. Tauxe of the CDC said the type of listeria linked to the cantaloupes is not one that is commonly associated with pregnancy-associated illnesses, however. State and federal health authorities have not definitively linked any miscarriages, stillbirths or infant illnesses to the current outbreak.

Symptoms of listeria include fever and muscle aches, often with other gastrointestinal symptoms. Victims often become incapacitated and unable to speak.

Debbie Frederick said her mother knew something was wrong when her father, 87-year-old William Thomas Beach, collapsed at his home in Mustang, Okla. and couldn't get up. He died a few days later, on Sept. 1. The family later learned his death was linked to eating the cantaloupe and sued Jensen Farms.

"First you just kind of go into shock," said Frederick. "Then it settles in that he would still be alive if this hadn't happened. It's a life, for what?"

___

Associated Press writers Jamie Stengle in Dallas, Josh Funk in Omaha, Neb., Maria Sudekum Fisher in Kansas City, Mo., Susan Montoya in Albuquerque, N.M. and Ben Neary in Cheyenne, Wyo. contributed to this report.

___

Online:

CDC on cantaloupe outbreak: http://www.cdc.gov/nczved/divisions/dfbmd/diseases/listeriosis/092111.html

FDA on cantaloupe recall: http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm

Center for Science and the Public Interest, "Super Safe Your Kitchen": http://www.cspinet.org/new/pdf/safekitchen.pdf

___

Find Mary Clare Jalonick on Twitter at http://twitter.com/MCJalonick

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Decade after anthrax attacks, worry over stockpile

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WASHINGTON (AP) — Anthrax vaccine — check. Antibiotics — check. A botulism treatment — check. Smallpox vaccine — check.

Ten years after the anthrax attacks brought home the reality of bioterrorism, the nation has a stockpile of some basic tools to fight back against a few of the threats that worry defense experts the most.

These defenses are not just gathering dust awaiting the next attack. In August, a Minneapolis hospital dipped into the stockpile to treat a critically ill patient — a tourist who, somewhere on his Midwest vacation, had the extraordinary bad luck to breathe anthrax spores that naturally linger in the dirt in parts of the country. The man, who survived, received a kind of medication not available in October 2001 when anthrax spores sent through the mail killed five people and sickened 17.

But there's wide concern that the nation's arsenal hasn't grown fast enough. A decade later, there are no treatments for a number of bugs on the worry list, and little to offer for other threats like a radiation emergency. Even a long-promised next-generation anthrax vaccine, that would be easier to produce, hasn't arrived yet. Nor is there information on how to treat children.

"Where are the countermeasures?" advisers to the Department of Health and Human Services asked in a critical report last year.

There are some: There's enough smallpox vaccine for everyone, plus some of a specially formulated version safe for cancer patients and others with weak immune systems. There's an improved version of the decades-old anthrax vaccine used in 2001. There are a few treatments for the toxins produced by anthrax and botulism, and a smallpox treatment is due soon.

But federal health officials are working to jumpstart production of more countermeasures and they say that more than 80 candidates are in advanced development. Over the past year, the goal has evolved into a push for more multiuse therapies, products that work not just for biodefense but for everyday health problems, too.

That's a major shift that should entice more big drug companies to the field, says Dr. Robin Robinson, who heads the federal Biomedical Advanced Research and Development Authority, or BARDA. It funds late-stage research of promising countermeasures.

Consider: BARDA just agreed to help pay for drug giant GlaxoSmithKline's testing of a novel antibiotic that might fight bioterrorism germs like plague — as well as certain hospital-spread bacteria that cause such problems as pneumonia in the already seriously ill.

So-called broad-spectrum antibiotics that can kill more than one kind of bacteria aren't unusual — this one just targets some hard-to-treat types in a new way.

The next step: Scientists are beginning to create the first broad-spectrum antivirals, medicines that would treat more than one kind of virus. Rather than having an anti-flu drug and a separate anti-AIDS drug, the goal is to have a single injection that could treat those viruses plus the gruesome Ebola virus and a few more for good measure.

It's early work, still years away, cautions Dr. Michael Kurilla, biodefense research chief at the National Institute of Allergy and Infectious Diseases. But one of the antivirals is a direct result of biodefense research to understand how viruses infect — specifically, the Nipah virus that was the model for the even-scarier fictional bug in the new movie "Contagion."

And these multipurpose antivirals are a huge goal because if they pan out, the next time a brand-new virus emerges — like the respiratory SARS bug in 2003 — treatments might not have to be started from scratch.

"We feel very excited and confident that what we're working on ... can change the whole paradigm of how we approach infectious diseases," Kurilla says.

The U.S. has invested $67 billion in biosecurity since 2001, according to research by the Center for Biosecurity at the University of Pittsburgh Medical Center.

Most of that wasn't solely for biodefense but went to broader health programs that are as crucial for dealing with natural crises — like the 2009 swine flu global epidemic — as for dealing with manmade ones, says center director Dr. Thomas Inglesby. These include scientific research, beefing up struggling public health departments to better detect and treat emerging outbreaks, and training hospitals in disaster preparedness.

Inglesby worries that the economic crisis imperils those gains — public health funding already has been cut — and will further slow the countermeasure hunt. A program named BioShield that buys countermeasures for the stockpile expires in 2013 unless Congress reauthorizes it. It's time, he says, for the government to spell out its countermeasure priorities and how to reach them.

Meanwhile, what if another anthrax attack happened? No more scrambling to buy antibiotics: 60 million 60-day treatment courses are stockpiled, Robinson says, and the plan is for the U.S. Postal Service to deliver some of those first doses to people's homes.

Sometimes antibiotics aren't enough. In a severe infection, the germs can produce dangerous toxins that spread in the bloodstream. So also in the stockpile are two experimental toxin-clearing treatments, to be used if the immune system alone can't battle the toxin.

In August, Minnesota's sick tourist became the 19th person in the world ever treated with one of them — immune globulin culled from the blood of anthrax-vaccinated soldiers, says Dr. Mark Sprenkle of Hennepin County Medical Center. It's hard to know how much the drug contributed to the man's recovery, Sprenkle says, but his patient's toxin levels did drop more quickly after he began using it.

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EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press.

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