Drug industry advocates join chorus to split FDA

WASHINGTON – As momentum builds to rework the nation's food-safety system after a salmonella outbreak linked to peanuts, the drug industry is hoping for a happy side effect: faster approvals for new medicines.
Drug industry advocates are quietly allying with some of their longtime critics pushing to split the Food and Drug Administration into two agencies, one for food safety and one for medical products.
President Barack Obama bolstered hopes for a breakup last Saturday when he named two public health specialists to the agency's top positions and appointed an advisory group to reassess the nation's decades-old food safety laws.
Drug executives see a chance to speed up drug approvals that have lagged amid a drought of new products, provided their regulator is no longer distracted by high-profile food-safety breakdowns.
"Every CEO that I know in health care is in favor of this, but none that value their share prices will go on the record for fear of retribution from the FDA," said Steve Brozak, president of WBB Securities, an investment brokerage focused on drug and biotech companies.
While FDA's food and drug staffs are separate, Brozak and others believe the public lashings over food outbreaks have made senior officials even more risk-averse on drug approvals. Even before the recent food safety problems, FDA was under pressure from Congress for failing to catch problems with drugs like Merck's Vioxx, which was pulled from the market in 2004.
"The history of FDA is that the commissioner focuses on medical products and only turns to food safety when a crisis comes up," said Professor Michael Taylor, a former FDA and U.S. Department of Agriculture official now at George Washington University.
This year, the agency will spend just 73 cents on food safety for every dollar spent on drugs, according to the Institute of Medicine.
Recent outbreaks connected with spinach, lettuce, peppers and tainted milk from China have created a drumbeat for change.
Margaret Hamburg, a former New York City Health Commissioner, has been tapped to address these issues as Obama's pick for FDA commissioner. Her deputy will be Joshua Sharfstein, a pediatrician and critic of the safety of children's cold medicines.
One former FDA official said Obama's appointment of two safety experts suggests he favors splitting the agency.
"Peggy Hamburg is a safety and security expert, and it seems pretty clear she would become administrator of the food agency," said Peter Pitts of the Center for Medicine in the Public Interest, an industry-funded advocacy group. "Josh Sharfstein would then slide over" to head the drug agency.
The FDA's associate commissioner for food, Dr. David Acheson, would only say, "The agency welcomes all discussions about ways to make our food supply even safer."
The drug industry's lobbying group has not taken a position on a new drug agency. But the group's president says the status quo is unacceptable.
"One of our premier scientific agencies that's responsible for all of our health and safety is still living in the 19th century in many ways, and we shouldn't tolerate that," said Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America and a former congressman from Louisiana.
The distraction created by food crises is wreaking havoc on the drug industry and its investors, making it harder to predict which drugs the agency will approve, Brozak and others say.
"That makes for a completely untenable position for people trying to make decisions in the health care capital markets," said Brozak, who ran for Congress as a Democrat in 2004.
Last year the FDA missed review deadlines on more than 12 drugs, or more than 20 percent of those received, analysts estimate. The agency's internal goal is to miss no more than 10 percent. FDA officials have blamed one-time problems, including an influx of new staffers.
Experts say there's no reason the agency that assures the safety of complex, $3,000-a-month biotech drugs is also tasked with regulating $3 jars of peanut butter.
The Government Accountability Office endorsed a single food agency in 1999, and lawmakers have been trying unsuccessfully to realize it ever since.
Splitting FDA would likely mean reshuffling committees that oversee food and drug regulation, which could diminish clout and contributions for some lawmakers.
"Once you get an idea like this on Capitol Hill, it creates winners and losers in power and dollars, and when that happens, it usually results in a stalemate," said Patrick Ronan, a former FDA staffer and founder of GreenLeaf Health consultants.
Sen. Dick Durbin, D-Ill., and Rep. Rosa DeLauro, D-Conn., have narrowed their proposals in order to gain support.
DeLauro previously aimed to consolidate food responsibilities, including the USDA's, into one agency, which proved to be politically tricky. Her current bill would carve a separate agency out of FDA with additional powers, including ordering recalls, which are now voluntary, and increasing food inspections.
The Congresswoman said she welcomes Obama's formation of a food safety task force, but showed no sign of backing away from her proposal. The task force must not be "merely a cosmetic bureaucratic endeavor," she said in a statement.
"The working group must produce definitive recommendations that result in the modernization of our food safety regulatory structure."
Durbin's bill similarly would expand FDA powers and would add $775 million to its budget to bolster food safety. Currently, the FDA's $1.9 billion federal budget is supplemented by more than $300 million in application fees paid by drugmakers to fund speedy reviews.

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Brain injury victims can seem OK, symptoms delayed

At first, Natasha Richardson said she felt fine after she took a spill on a Canadian ski slope. But that's not unusual for people who suffer traumatic head injuries like the one that killed the actress.
Doctors say sometimes patients with brain injuries have what's called a "lucid interval" where they act fine for an hour or more as the brain slowly, silently swells or bleeds. Later, back at her hotel, Richardson fell ill, complained of a headache, and was taken to a hospital. She died Wednesday in New York.
An autopsy Thursday showed that the 45-year-old actress hit her head, which caused bleeding between the skull and the brain's covering, resulting in what's called an epidural hematoma. It's a type of injury often caused by a skull fracture.
Because of that lucid interval, doctors always tell patients who seem OK after a brain injury to have someone keep a close eye on them, in case symptoms emerge.
Symptoms — headache; loss of consciousness; vomiting; problems seeing, speaking or moving; confusion; drainage of a clear fluid from the nose or mouth — appear after enough pressure builds in the skull. By then it's an emergency.
"Once you have more swelling, it causes more trauma which causes more swelling," said Dr. Edward Aulisi, neurosurgery chief at Washington Hospital Center in the nation's capital. "It's a vicious cycle because everything's inside a closed space."
Pressure can force the brain downward to press on the brain stem that controls breathing and other vital functions, causing coma or death. Frequently, surgeons cut off a portion of the skull to give the brain room to swell. Or they drain the blood and remove clots that formed.
"This is a very treatable condition if you're aware of what the problem is and the patient is quickly transferred to a hospital," said Dr. Keith Siller of New York University Langone Medical Center. "But there is very little time to correct this."
Details of Richardson's treatment have not been disclosed.
A CT scan can detect bleeding, bruising or the beginning of swelling after an injury. The challenge is for patients to know whether to seek one.
"If there's any question in your mind whatsoever, you get a head CT," Aulisi advised. "It's the best 20 seconds you ever spent in your life."

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Attempting to zap Parkinson's through spinal cord

WASHINGTON – Implanting a pacemaker-like device deep in the brain helps some Parkinson's disease patients move better, but could less risky zapping of the spinal cord work instead? It did in mice and rats nearly immobilized with Parkinson's-like symptoms: Scientists at Duke University Medical Center turned on the electricity and videotaped the rodents immediately scurrying around almost like normal.
The research, reported in Friday's edition of the journal Science, is just a first step. More animal testing is needed to tell if the approach could be tried in people. Implants in marmosets, a type of primate, are to begin soon.
But sufferers of chronic pain already can have spinal cord stimulators implanted that send electrical currents to block the "I'm hurting" messages sent to and from the brain. For Parkinson's, the idea is similar.
The 1.5 million Americans with Parkinson's gradually lose brain cells that produce dopamine, a chemical key to the circuitry that controls muscle movement. The result: Haywire brain signaling that leads to increasingly severe tremors and periodically stiff or frozen limbs. Medication helps early in the disease. More severely affected patients may try "deep brain stimulation," where wires are implanted inside the brain to deliver tiny electrical zaps that disable overactive nerve cells and improve motor control.
Exploring a less invasive approach, the Duke team attached tiny wires to the spinal cords of mice and rats whose brains produced so little dopamine that they had the slow, stiff motions of advanced Parkinson's disease.
When the electricity was turned on, the animals became 26 times more active and movement visibly improved in seconds, Duke neuroscientist Dr. Miguel Nicolelis and colleagues wrote.
Why would it work?
Proper movement requires orderly nerve cell firing to different muscles at different moments in time, like members of an orchestra must play in proper sequence for a symphony.
There's increasing if circumstantial evidence that rhythmic waves of brain activity, called oscillations, play a role in Parkinson's movement problems — and that interrupting those abnormal waves allows the more normal, symphony-like brain cell firing to resume, said Dr. Walter Koroshetz, deputy director of the National Institute of Neurological Disorders and Stroke, which helped fund the work.
The spinal cord stimulation appears to have sent a signal up to the brain that interrupted those oscillations.
Koroshetz cautioned that much work remains, including testing whether the stimulator's effect might last long enough to be useful.
But, "it's something that has definitely got some scientific traction to it," he said. "It's a really good idea."

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Private inspections of food companies seen as weak

WASHINGTON – The mortgage meltdown exposed the weakness of self-regulation in financial markets. Now the salmonella outbreak is doing the same for the food industry.
A House subcommittee Thursday released new documents that showed how private inspectors contracted by Peanut Corp. of America failed to find long-standing sanitary problems at company facilities. Peanut Corp. is at the center of a nationwide outbreak that has sickened nearly 700 people and is blamed for at least nine deaths.
Lawmakers said the food industry's private inspection system failed to catch filthy conditions because the company itself hired the inspectors.
"There is an obvious and inherent conflict of interest when an auditor works for the same supplier it is evaluating," said Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce investigations subcommittee. He termed it a "cozy relationship."
Last summer, Peanut Corp.'s private inspector, a company called AIB, awarded the peanut processor a certificate in 2008 for "superior" quality at its Plainview, Texas, plant. This year, salmonella was discovered there.
The outbreak was initially traced to a Peanut Corp. facility in Blakely, Ga. Later, contamination was found at the Texas plant. Peanut Corp. is under criminal investigation for allegedly shipping products it knew to be tainted.
Owner Stewart Parnell has refused to answer questions from lawmakers, citing constitutional protections against self-incrimination. On Thursday, Parnell told The Associated Press he couldn't comment on the allegations and referred questions to his attorney, who was not immediately available.
Federal law does not require food companies to pay for their own inspections of suppliers. Nor are industry labs and inspectors required to tell the government about any problems they find.
At least one food company that used its own inspectors, Nestle USA, ultimately decided not to do business with Peanut Corp. Nestle USA had no recalls. But a Nestle affiliate in Puerto Rico recalled some ice cream products, and Nestle HealthCare Nutrition — another affiliate — recalled a nutritional bar.
The committee released a 2002 Nestle USA inspection report of Peanut Corp.'s Blakely plant. "They found that the place was filthy," said Rep. Henry Waxman, D-Calif.
A second audit by Nestle USA of Peanut Corp.'s Texas facility in 2006 also found major pest control and other problems. The audit said that would disqualify the plant from supplying chopped peanut pieces to sprinkle atop Drumstick ice-cream cones.
Auditors found at least 50 mouse carcasses in and around the plant and also a dead pigeon "lying on the ground near the peanut-receiving door."
The audit also said the plant had no pathogen-monitoring plan and noted that one needed to be developed for the plant to be in compliance with audit standards.
Companies that bought ingredients from Peanut Corp. said they had no way of defending themselves against a supplier they accuse of deliberately breaking the rules and covering up.
"I think we did everything we could do," Kellogg Co. chief executive David Mackay told the committee.
"The issue was that (Peanut Corp.) acted in a dishonest and unethical way," he added.
Lawmakers and the Obama administration say the problem goes beyond a rogue company, and major reforms are needed. Legislation has been introduced in Congress to take food safety oversight away from the Food and Drug Administration and give it to a new agency with stronger legal powers and more funding.
Peanut Corp. produced not only peanut butter, but peanut paste, an ingredient found in foods from granola bars and dog biscuits to ice cream and cake. More than 3,490 products have been recalled, including some millions of Kellogg's Austin and Keebler peanut butter sandwich crackers.
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On the Net:
FDA salmonella page: http://tinyurl.com/8srctw

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Call for autopsy to unravel tragedy of stillbirth

WASHINGTON – Adding to the devastation of her daughter Clare being stillborn is the fact that Erin Fogarty Owen doesn't know why: What went wrong in a pregnancy that seemed textbook? And that unknown means Owen is facing her new pregnancy with as much fear as joy, repeating what she calls sanity sonograms for reassurance that this baby's still fine.
More than 25,000 U.S. babies a year are stillborn, and in more than a third of the cases doctors can't find an explanation. New guidelines for obstetricians aim to help change that with a too often taboo recommendation: Gently urge more parents to accept an autopsy to help unravel this mystery killer, so that maybe doctors can start preventing it.
Even an autopsy doesn't always give an answer. It didn't explain why Clare Owen died.
The hope is that if more are performed — and done better, to the same set of standards — scientists might finally have enough tests to compare and uncover risk factors that doctors today know nothing about.
"We need some answers," says Owen, of Arlington, Va. "It all starts at the bedside of the grieving parent who's just been told her baby is dead."
The new guidelines from the American College of Obstetricians and Gynecologists come as bereaved parents and child advocates are pushing to break the silence that surrounds those deaths.
"People don't want to frighten their patients near the end of pregnancy," says Dr. Ruth Fretts of Harvard Vanguard Medical Associates and the Harvard Medical School, who led the new guidelines. "So basically the issue about late stillbirth is generally not brought up. We've been afraid to talk about it."
Among Fretts' top questions: Should older and other higher-risk mothers be induced before their due dates? And some doctors order women to count their babies' kicks in late pregnancy while others don't. Should they, and what tests are needed to tell if dwindling movement means trouble or a false alarm?
"My dream of being a mother will soon be here," Owen signed off her online journal at 2:39 a.m. on March 7, 2008, while feeling early contractions.
"My God, how do I tell you the news?" is the next entry, on March 24.
She'd woken her husband, Rob, shortly after her optimistic signoff and headed for the hospital — where they almost immediately learned Clare had no heartbeat.
"My beautiful, kicking, active, hiccuping little girl was dead," she wrote, returning to her journal as catharsis.
Most at risk are black women — they have roughly twice the rate of stillbirths as other U.S. women — and mothers age 35 and older, even if they seem just as healthy as younger women. Obesity, diabetes and high blood pressure also increase the risk.
Birth defects, problems with the placenta and too little fetal growth account for many stillbirths. But there's been no progress in a decade in explaining the rest, babies like Clare Owen who appear normal despite intense testing and whose mother's only risk factor was age, 37.
Few stillbirths occur during labor in developed countries. Usually a woman has labor induced after her baby has died.
Early into hours of labor, Owen vividly remembers a comforting nurse rubbing her arm while asking her to consider an autopsy to find out what happened. Owen didn't hesitate; she needed to know.
Fretts estimates a third of mothers never get asked about an autopsy, and there's no good count of how many are done. It's a delicate issue for families who may know the procedure only from grisly TV crime shows. The guidelines stress explaining that such testing can be crucial to calculating future pregnancy risk and needed care, and is conducted with respect. Families who reject a full autopsy should be offered alternatives, such as full-body X-rays and biopsies, the guidelines say.
An autopsy isn't immediate. The Owens spent seven hours with Clare to say goodbye. Complicating the choice, insurance doesn't always pay — Owen's did — and the tab can reach $1,500.
Moreover, Fretts says most death certificates are filled out before a stillbirth assessment is completed, meaning scientists culling them for new clues never see key information.
"That isn't good enough," says Owen, frustrated that Clare's autopsy merely ruled out known stillbirth causes. The main clue was that Clare weighed almost 11 pounds, startling for slim parents. "We need to get together and come up with better answers."
To help, Sen. Frank Lautenberg, D-N.J., is writing legislation that aims to increase stillbirth research and public awareness. Also, the March of Dimes is designing a Web-based tool to one day guide women in asking relatives about miscarriages, stillbirths and other family conditions, helping doctors better determine their risk and alter prenatal care accordingly.
For now, Owen is hanging onto sympathetic care from a high-risk OB practice that allows repeated reassurance sonograms during her new pregnancy — and figuring out how to handle well-meaning "is this your first" queries from strangers.
"Do I, you know, bring this person down by saying, 'Oh no, we have one in heaven and we hope that we get to keep this one?' I can't deny Clare's existence, but it's also very uncomfortable," she says.
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EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
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On the Net:
American College of Obstetricians and Gynecologists: http://www.acog.org
Stillbirth-related groups: http://www.firstcandle.org and http://www.stillbirthalliance.org

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Fewer kids have high lead levels than 20 years ago

CHICAGO – In a stunning improvement in children's health, far fewer kids have high lead levels than 20 years ago, new government research reports — a testament to aggressive efforts to get lead out of paint, water and soil.

Lead can interfere with the developing nervous system and cause permanent problems with learning, memory and behavior. Children in poor neighborhoods have generally been more at risk because they tend to live in older housing and in industrial areas.

Federal researchers found that just 1.4 percent of young children had elevated lead levels in their blood in 2004, the latest data available. That compares with almost 9 percent in 1988.

"It has been a remarkable decline," said study co-author Mary Jean Brown of the Centers for Disease Control and Prevention. "It's a public health success story."

The 84 percent drop extends a trend that began in the 1970s when efforts began to remove lead from gasoline. The researchers credited continuing steps to reduce children's exposure to lead in old house paint, soil, water and other sources.

The study was being released Monday in the March edition of the journal Pediatrics. It is based on nearly 5,000 children, ages 1 to 5, who were part of a periodic government health survey.

The government considers levels of at least 10 micrograms of lead per deciliter of blood to be elevated, although research has shown that levels less than that can still cause problems including attention and reading difficulties. There is no known "safe" level, the study authors noted.

Caroline Cox, research director of the Center for Environmental Health, a California-based advocacy group, noted that lead poisoning "is entirely preventable."

"There's no reason even one child in the United States should be poisoned by lead," Cox said. "It's great there aren't as many now as there were, but there are still too many."

By 2004, racial disparities among children with blood-lead levels higher than 10 micrograms had mostly disappeared: About equal numbers of white, black and Mexican-American children had levels in that range.

However, disparities at lower levels remained. For example, almost 18 percent of white children had levels of less than 1 microgram per deciliter, versus 11 percent of Mexican-Americans and 4 percent of blacks.

Children from lower-income families also had higher lead levels than those from wealthier families.

Dr. Bruce Lanphear, a lead specialist at Cincinnati Children's Hospital Medical Center who wasn't involved in the government study, said lead levels have probably continued to decline since 2004. But the findings show "we need to still continue to be aggressive" with prevention efforts, he said.

Lead-based paint in old housing, which can contaminate house dust and soil, is the main source. Children also can be exposed to lead in water, mostly from old plumbing pipes, as well as toys and certain folk medicines.

The CDC recommends that pregnant women and young children avoid housing built before 1978 that is undergoing renovation. Other recommendations include regularly washing children's hands and toys; frequent washing of floors and window sills, where paint dust can collect; and avoiding hot tap water for drinking, cooking and making baby formula. Hot tap water generally contains higher lead levels from plumbing than cold water.

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On the Net:

Pediatrics: http://www.pediatrics.org/

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

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Finding genes that make teeth grow all in a row

WASHINGTON – Ever wonder why sharks get several rows of teeth and people only get one? Some geneticists did, and their discovery could spur work to help adults one day grow new teeth when their own wear out.
A single gene appears to be in charge, preventing additional tooth formation in species destined for a limited set. When the scientists bred mice that lacked that gene, the rodents developed extra teeth next to their first molars — backups like sharks and other non-mammals grow, University of Rochester scientists reported Thursday.
If wondering about shark teeth seems rather wonky, consider: Tooth loss from gum disease is a major problem, here and abroad, and dentures or dental implants are far from perfect treatments. If scientists knew exactly what triggers a new tooth to grow in the first place, it's possible they could switch that early-in-life process on again during adulthood to regenerate teeth.
"It's exciting. We've got a clue what to do," said Dr. Songtao Shi of the University of Southern California School of Dentistry, who said the Rochester discovery will help his own research into how to grow a new tooth from scratch.
Also intriguing: All the mice born without this gene, called Osr2, had cleft palates severe enough to kill. So better understanding of this gene might play a role in efforts to prevent that birth defect, the Rochester team reported in the journal Science.
Teeth may not be visible until long after birth, but they start to form early in embryo development. Teeth ultimately erupt from a thickened band of tissue along the jaw line called the dental lamina, a band that forms in a top layer of the gum called the epithelium. Scientists have long thought the signals for tooth formation must lie in that tissue layer as well.
Not so, the Rochester team found: All the action takes place instead in a deeper cell layer called the mesenchyme.
Think of the Osr2 gene as a control switch, a kind of gene that turns on and off the downstream actions of other genes and proteins. In that mesenchymal tissue, the Osr2 gene works in concert with two other genes to make sure budding teeth form in the right spot, said lead researcher Dr. Rulang Jiang, a geneticist at Rochester's Center for Oral Biology.
"It's almost a self-generating propagation of the signal" that leads to one tooth after another forming all in a row, he explained.
Knocking that molecular pathway out of whack causes either missing or extra teeth to result, Jiang showed in a series of mouse experiments.

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Study: Old drugs might give TB a 1-2 punch

WASHINGTON – Scientists might have found a way to deal drug-resistant tuberculosis a one-two punch using two old, safe antibiotics — and studies in ill patients could begin later this year.
TB is one of the world's oldest killers, and the lung disease still claims the lives of more than 1.5 million people globally every year. The bacteria that cause TB are fast becoming impervious to many treatments, drug resistance that is seen worldwide but is a particular problem in parts of Asia and Africa. While typically the TB doesn't respond to two top treatments, an emerging threat is so-called extensively drug-resistant disease, or XDR-TB, that is virtually untreatable by remaining options.
So researchers are frantically hunting new approaches, including taking a fresh look at some old drugs.
TB bacteria contain a certain enzyme that renders the penicillin family of antibiotics drugs useless.
"It chews them up and spits them out and they never get to see their target," explained biochemist John Blanchard of the Albert Einstein School of Medicine.
But there are different antibiotics that can block that enzyme, called beta-lactamase. One, named clavulanate, has long been sold as part of the two-drug Augmentin combination that's widely used for various children's infections.
So Blanchard's team tested whether administering clavulanate might make TB vulnerable to other antibiotics — and found a combination that in laboratory tests blocked the growth of 13 different drug-resistant TB strains.
The combo: Clavulanate to drop TB's shield, plus a long-sold injected antibiotic — meropenem, part of that penicillin-style family — that then attacks the bacteria.
The findings are reported Thursday in the journal Science.
What happens in a lab doesn't necessarily work in people. Still, the findings were so compelling that two teams of U.S. researchers — from the National Institutes of Health and New York's Montefiore Medical Center — already are planning small patient studies in South Korea and South Africa. They hope to begin those studies later this year.
"It's very clever," said Dr. Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases. When one drug knocks out the TB microbe's defense, "that leaves the original drug with the capability of doing what it's supposed to be doing."

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Octuplets born 'screaming and kicking' in Calif.

BELLFLOWER, Calif. – A woman gave birth to eight babies in Southern California on Monday, the world's second live-born set of octuplets.

The mother, who was not identified, gave birth to six boys and two girls weighing between 1.8 pounds and 3.4 pounds, doctors at Kaiser Permanante Medical Center told The Associated Press.

"It's a surprise," Dr. Karen Maples said. "Eight newborns are in stable condition and they're doing quite well."

Kaiser spokeswoman Myra Suarez said she could not release any information about the mother, including her condition or whether she used fertility drugs. Such drugs make multiple births more likely.

"They are all doing the best they can," Suarez told the AP.

The first baby was born at 10:43 a.m.; the eighth one at 10:48 a.m.

"They were all screaming and kicking around very vigorously," Dr. Harold Henry told the TV station.

The first live-born octuplets were born in Houston in 1998, and one baby died about a week later. The surviving siblings — girls Ebuka, Gorom, Chidi, Chima and Echerem, and their brothers Ikem and Jioke — celebrated their 10th birthday in December.

Their parents, Nkem Chukwu and Iyke Louis Udobi, said they are astonished and grateful that their children have grown up to be healthy and active kids who are now in the fourth grade.

Chukwu said the new parents have much to look forward to.

"Just enjoy it. It's a blessing, truly a blessing," Chukwu said. "We'll keep praying for them."

The Bellflower medical center is about 17 miles southeast of Los Angeles.

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Associated Press writers Denise Petski and Alicia Chang in Los Angeles contributed to this report.

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How to help when smoking, alcohol complicate PTSD

WASHINGTON – Reaching for a cigarette to cope with a flashback is all too common among sufferers of post-traumatic stress disorder. The nicotine hit may feel good but scientists say its brain action probably makes their PTSD worse in the long run.
Here's the rub: At least half of PTSD sufferers smoke, and others wind up dependent on alcohol, anti-anxiety pills, sometimes even illegal drugs. Yet too few clinics treat both PTSD and addictions at the same time, despite evidence they should.
Now studies are recruiting PTSD patients — from New England drug-treatment centers to veterans clinics in North Carolina and Washington — to determine what combination care works.
"It's kind of a clinical myth that you can only do one at a time or should only do one at a time," says Duke University PTSD specialist Dr. Jean Beckham, a psychologist at the Durham, N.C., Veterans Affairs Medical Center. "Everybody's afraid to have their patients quit smoking because they're afraid they're going to get worse. There's not a lot of empirical data about that."
And her research on how to break the nicotine-and-PTSD cycle raises a provocative question for a tobacco-prone military: Are people at higher risk of developing PTSD if they smoke before they experience the violent event or episode?
Post-traumatic stress disorder — which can include flashbacks, debilitating anxiety, irritability and insomnia — is thought to affect nearly 8 million Americans at any given time. Anyone can develop it after a terrifying experience, from a mugging to a hurricane, a car crash to child abuse. But PTSD is getting renewed attention because so many veterans returning from combat in Iraq and Afghanistan seem vulnerable. A study last year by the RAND Corp. research organization estimated nearly 20 percent of them, or 300,000 people, have symptoms of PTSD or major depression.
What's less discussed is that patients often don't realize they might have PTSD and try to relieve symptoms by self-medicating with alcohol, tobacco and other substance use — worsening habits that existed before the trauma or starting anew.
Addiction itself is a mental health disorder that causes changes in some of the same brain areas disrupted by mood and anxiety disorders like PTSD, says a new report on the co-illnesses from the National Institute on Drug Abuse. That argues for simultaneous treatment. Indeed, up to 60 percent of people in addiction treatment are estimated to have PTSD — although they seldom acknowledge symptoms — and they're three times more likely than other patients to drop out.
A handful of studies suggest combo care helps. One example: VA researchers in Connecticut gave the alcoholism drugs naltrexone and disulfiram to PTSD patients, and watched not only their drinking ease but their PTSD symptoms improve, too.
Then there's nicotine. It temporarily enhances attention when it hits the brain — one reason that members of military tell the VA's Beckham they smoke. Although PTSD patients say a cigarette helps their mood when they're having symptoms, the extra attention may be reinforcing bad memories.
"If you think about your traumatic event and you smoke your cigarette, you can think about it even better," explains the VA's Beckham.
Yet the NIDA report found combination care rare, partly because of our specialty-driven health system.
Another big reason: "The majority of people with PTSD don't seek treatment," Dr. Mark McGovern of Dartmouth Medical School told a NIDA meeting this month that brought together military and civilian experts to jump-start research.
"People try to swallow it or take care of it on their own and it just kind of gets out of control," agrees Bryan Adams, 24, who is working with the Iraq and Afghanistan Veterans of America to raise PTSD awareness.
Adams, now a business major at Rutgers University, was awarded a Purple Heart after being shot when his Army patrol was ambushed in Iraq in 2004. Back home he handled restlessness and irritability with increasing alcohol use. Only when he got into college did a checkup lead to a PTSD diagnosis and therapy. He quit excessive drinking as the PTSD improved, despite no formal alcohol treatment.
The new studies may prompt more merging of care:
_In Durham, Beckham is giving PTSD-suffering smokers either a nicotine patch or a dummy patch to wear for three weeks before they quit smoking. The theory: Steady nicotine release will blunt a cigarette's usually reinforcing hit to the brain, possibly helping both withdrawal symptoms and the intensity of PTSD symptoms.
_In some New Hampshire and Vermont substance-abuse clinics, McGovern is randomly assigning patients to standard addiction-only care or cognitive behavioral therapy traditionally used for PTSD. A pilot study found the cognitive behavioral therapy improved both PTSD symptoms and substance use.
_In Seattle, researchers at the VA Puget Sound Health Care System have PTSD therapists conducting smoking cessation therapy in the same visit. In a pilot study, those patients were five times more likely to quit cigarettes than PTSD patients sent to separate smoking programs.
___
EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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FDA reviews benefits of Plavix in certain patients

WASHINGTON – Federal health officials are investigating whether the blood thinner Plavix — the world's second-best-selling drug and used by millions to reduce the risk of heart attack and stroke — may be less effective in some patients.

The Food and Drug Administration said Monday it is reviewing reports that certain heartburn medications can neutralize the benefits of Plavix. The agency said it is also investigating whether patients from certain genetic backgrounds also don't reap the drug's benefits.

In both cases, FDA said patients may have trouble metabolizing Plavix, reducing its ability to prevent deadly blood clots.

Plavix had global sales of $7.3 billion in 2007. The drug is marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA and has been prescribed to more than 90 million patients around the world.

In November, researchers found that taking Plavix with popular prescription heartburn drugs like AstraZeneca PLC's Nexium significantly increased patients' chances of being hospitalized for a heart attack, stroke or chest pain. The researchers suggested that the heartburn drugs might interfere with a liver enzyme needed to metabolize Plavix.

However, some heart experts were skeptical of the findings. They noted that patients taking heartburn drugs may already have health problems that skew their risk for heart attack and other problems.

Doctors prescribe so-called proton pump inhibitor drugs to treat heartburn, in which painful stomach acids come back up the esophagus. Because Plavix, known generically as clopidogrel, can upset the stomach, it is often prescribed with the acid-blocking drugs, which include Wyeth's Protonix.

FDA said in a statement it is important to determine how the drugs interact because "decreases in the effectiveness of clopidogrel might be avoided, in part, by using other drugs ... that do not interfere with its metabolism."

FDA said there is no evidence that the "H2 blocker" family of heartburn drugs counteract Plavix. Those drugs include Johnson & Johnson's Pepcid, Boehringer Ingelheim's Zantac and GlaxoSmithKline's Tagamet HB.

Sanofi-Aventis and Bristol-Myers Squibb said they are conducting studies of whether genetic factors or heartburn drugs can interfere with Plavix.

"Individuals do not all respond to the same degree to a specific drug," said Sanofi spokeswoman Elizabeth Baxter. "Many studies are currently ongoing, including studies of clopidogrel, to explore what is responsible for this phenomenon."

The studies will take several months to complete, according to FDA, which said it would issue recommendations after reviewing them.

Until more information is available, the FDA says patients should continue taking Plavix. However, doctors should be cautious when prescribing the heartburn drugs to patients already taking Plavix.

In general, the FDA has begun notifying the public earlier about possible safety issues involving drugs. The policy change came after the agency was criticized for acting too slowly on information about medicines that were later removed from the market due to safety reasons.

Shares of Paris-based Sanofi-Aventis rose 23 cents Monday to $30.60 in midday trading. Shares of New York-based Bristol-Myers Squibb Co. dipped 1 cent to $22.38.

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Future of abstinence-only funding is in limbo

NEW YORK – With the exit of the Bush administration, critics of abstinence-only sex education will be making an aggressive push to cut off federal funding for what they consider an ineffective, sometimes harmful program.
How quickly and completely they reach their goal is uncertain, however, as conservative supporters of abstinence education lobby Congress and President-elect Barack Obama to preserve at least some of the funding, which now totals $176 million a year.
And even if federal funding is halted, some states — such as Georgia — are determined to keep abstinence programs going on their own, ensuring that this front in the culture wars will remain active.
Obama is considered an advocate of comprehensive sex education, which — unlike abstinence-only curriculum — includes advice to young people about using contraceptives if they do engage in sexual activity. However, Obama spokesman Tommy Vietor declined to elaborate on what the new president would propose in his own budget plan.
Cecile Richards, president of the Planned Parenthood Federation of American, depicted the federal abstinence-only program as "an utter failure that has wasted more than $1.5 billion" over the past decade. Like other critics, she noted that several major studies — including a federally funded review — have found no evidence that the abstinence-only approach works in deterring teen sex.
"Talking with Obama, he totally understands the need for young people to have comprehensive sex education — they need information that protects their health," Richards said. "I hope that will be the position of the administration, but when Congress gets involved, sometimes things get more complicated."
Even after Democrats took control of Congress in the 2006 elections, liberals lacked the votes to end abstinence-only funding, and President George Bush stuck by his strong support for it.
But Rep. Louise Slaughter, D-N.Y., said the 2008 elections not only put Obama in the White House but also increased the ranks of senators and representatives who share her opposition to funding abstinence education.
"We believe the amount of money that goes into it would be so much better used on things to prevent unwanted pregnancies," she said. "I think we'll have enough votes to deal with it."
Slaughter is a lead sponsor of the Prevention First Act, introduced this month in the House and Senate, that proposes multiple initiatives to reduce unintended pregnancies. One component calls for promoting "medically accurate" comprehensive sex education.
Supporters of abstinence education acknowledge the shift of political power in Washington, but they have appealed to Obama to preserve some federal funding for their programs.
Valerie Huber, executive director of the National Abstinence Education Association, suggested that one option would be for Congress "to allow true choice" by approving funding for both comprehensive and abstinence-focused programs.
Referring to recent data showing increases in teen births and sexually transmitted diseases among young people, she said, "Now is not the time to remove even one of the tools that can help teens."
However, Slaughter said she would oppose any effort to fund both approaches.
"We can't have both, because abstinence-only doesn't work," she said.
Among the organizations attempting to bridge the ideological divide on sex education is the National Campaign to Prevent Teen and Unplanned Pregnancy.
Its director, Sarah Brown, said the campaign's approach is "science-driven" — favoring comprehensive sex education over the abstinence programs.
"In a highly constrained fiscal environment, it's critical to focus precious dollars on programs that have evidence of good effects," Brown said. "When you look at the best science, the abstinence-only programs come up short."
Still, she said there could be a long-term benefit to conducting research on whatever abstinence programs do endure.
"I suspect that if research community keeps testing them, there might be a couple that do have an effect," she said.
Georgia supplements its federal abstinence money with more than $500,000 of state funds.
"Abstinence education will remain a strategy of our youth development initiative regardless of what happens at the federal level," said Jen Bennecke, executive director of the Governor's Office for Children and Families.
She credited the Georgia program — which includes character-development curriculum — with contributing to a 50 percent decrease in teen pregnancies since its inception 11 years ago.
Roughly half the states receive federal abstinence funding — the others have spurned the program, under which instructors are directed to teach that sexual activity outside of marriage is likely to have harmful psychological and physical effects.
Supporters of abstinence education say it promotes the only method that's 100 percent effective in preventing pregnancy and sexually transmitted disease. Critics say the abstinence programs don't deter teens from having sex, leave them without crucial information on avoiding pregnancy and STDs, and in some cases provide false information about condoms' reliability.
___
On the Net:
Abstinence Education Association: http://www.abstinenceassociation.org/
Campaign to Prevent Teen Pregnancy: http://www.thenationalcampaign.org/default.aspx

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New 'Joy of Sex' Slim on Science

An updated edition of "The Joy of Sex" is newly released this month with more sexological detail, but the how-to manual remains scientifically superficial on the topic of anatomy.
In 1972, the British doctor Alex Comfort published "The Joy of Sex," an illustrated guide for couples of a newly liberated generation. His goal was to remove shame and confusion from an act that he saw as intrinsically human and healthy; as he wrote in 1991, he had hoped his book would "undo some of the mischief caused by the guilt, misinformation, and lack of information."
There have been several editions of "The Joy of Sex" in subsequent years, the most recent being Susan Quilliam's "Ultimate Revised Edition" (Crown, 2009).
Quilliam removes some of Comfort's more dated passages - including racist undertones and the encouragement of open relationships - while adding the findings of "key scientific discoveries in recent years in the fields of physiology, psychology, psychotherapy, and medicine." In addition, as she writes in the preface, "the advent of sexology - the specialist study of sexual matters - has resulted in both rigorous academic research and a more widespread public awareness of, and skill in, sex."
Most of these key scientific discoveries come early in the book, in a section called "Ingredients" ("The Joy of Sex" was modeled on "The Joy of Cooking," and uses culinary metaphor throughout).
Topics in "Ingredients" include pheromones, which are thought by some to be responsible for the correlation of desirability and smell; hormone replacement therapy; and sex education, where it is noted that "sex education actively raises the age at which adolescents first have sex and lowers the number of partners they have and the number of risks they take."
In "Appetizers," Quilliam offers three pages on STDs, including a step-by-step illustration of proper condom use. Readers might also be interested to learn that a man's average ejaculate is approximately 5 calories and contains "a dose of vitamin C."
Despite these additions, "The Joy of Sex" is by no means a scientific treatise: Its most popular section has been and will likely remain "Main Courses," which features instructional illustrations of different sexual positions. There is also some unscientific wording surrounding body parts and their functions: the scrotum is "basically, a sperm factory," and the vagina is almost always called the "p****." (The penis, it should be noted, is never given a more colloquial name.)
Scientific or not, the new edition continues its tradition of good intentions. The first ingredient of sex is listed as "tenderness," which is defined as "a constant awareness of what your partner is feeling, plus the knowledge of how to heighten that feeling, gently, toughly, slowly, or fast." That's experimentation that anyone can conduct.
The Sex Quiz
Video - Aspirin and Sex Drive
Top 10 Bad Things That Are Good for You
Sally Law has written about health and sexuality for the Cleveland Clinic, and has appeared regularly as a guest host on Sirius Radio. Her column, The Science of Sex, appears weekly on LiveScience.
Original Story: New 'Joy of Sex' Slim on ScienceLiveScience.com chronicles the daily advances and innovations made in science and technology. We take on the misconceptions that often pop up around scientific discoveries and deliver short, provocative explanations with a certain wit and style. Check out our science videos, Trivia & Quizzes and Top 10s. Join our community to debate hot-button issues like stem cells, climate change and evolution. You can also sign up for free newsletters, register for RSS feeds and get cool gadgets at the LiveScience Store.

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U.S. Chlamydia Infections Hit All-Time High

TUESDAY, Jan. 13 (HealthDay News) -- The number of Americans newly infected with the sexually transmitted diseases chlamydia and syphilis continues to rise, federal health officials reported Tuesday, with chlamydia infections hitting a record million-plus new cases annually.


The numbers, from 2007, show that cases of chlamydia as well as syphilis rose for the third year in a row, according to a report by the U.S. Centers for Disease Control and Prevention (CDC).


"The bad news from last year has continued," said Dr. John M. Douglas Jr., director of the CDC's Division of STD Prevention. "These infections remain at very high levels, and frankly, unacceptably high."


Chlamydia and gonorrhea, the two most commonly reported infectious diseases in the United States, together accounted for almost 1.5 million reported cases of sexually transmitted disease (STD) in 2007.


"Chlamydia is at a new all-time record 1.1 million cases -- it went up about 7 percent since 2006," Douglas said. "Gonorrhea is about at 355,000 cases."


STDs, although easily diagnosed and treated, frequently occur without symptoms and may go untreated. Left untreated, chlamydia and gonorrhea can result in pelvic inflammatory disease -- a condition that causes as many as 50,000 U.S. women to become infertile each year, according to the report, Sexually Transmitted Disease Surveillance, 2007.


The overall rate of chlamydia infections among women was 543.6 cases per 100,000 females, almost three times the rate among men -- 190 cases per 100,000 males, the report said.


The increasing number of chlamydia cases is actually a reflection of more people being screened, not a greater incidence of the disease in the population, Douglas said. "It's kind of a mixed piece of good news. We wish those numbers were going down, but we know they have to go up before they go down," he said.


Gonorrhea rates have been stable for about the last 10 years, Douglas said. "This is stable at quite a high level. It represents an example where we have a job half done. Gonorrhea has come down since its highpoint in the 1970s, but we just got stuck in the late 1990s, and we've been stuck ever since then," he said.


Rates of gonorrhea were also higher among women -- 123.5 per 100,000 women -- compared with 113.7 per 100,000 men, according to the report.


But these numbers are probably just the tip of the iceberg, Douglas noted. The CDC estimates that only half of all new chlamydia and gonorrhea infections are reported, bringing the actual number of infected people to more than 3 million.


"We think there are really 2 to 2.5 million cases of chlamydia a year," he said.


The report also found continued increases in rates of syphilis. On the verge of elimination just a decade ago, syphilis rates began increasing in 2001 and rose 15.2 percent between 2006 and 2007, Douglas said.


"We got set back in a recurrence of syphilis among men who have sex with men," Douglas said. "There has been limited success in trying to curb that, but we have begun to see a slide in some of the better-controlled populations."


The increases in syphilis in 2007 were predominately among women. "We have seen increases in babies, which is the ultimate innocent bystander population," Douglas said.


What's more, if you have syphilis, you also have a 50 percent chance of being HIV-positive, he added.


The report found continued racial disparities for STD cases. Gonorrhea was 19 times more common among blacks than whites; chlamydia was eight times more common; and syphilis was seven times more common, Douglas said.


Black women 15 to 19 years old had the highest rates of both chlamydia (9,647 per 100,000 population) and gonorrhea (2,956 per 100,000 population), according to the report.

Sexually transmitted diseases take a significant economic toll -- the CDC estimates that STDs cost the U.S. health-care system an estimated $15.3 billion annually.

Douglas said greater public health campaigns are needed to reverse the trend.

"These diseases can be treated, and we need to have better awareness about how extensive these infections are and what the prevention opportunities are," he said.

Dr. David L. Katz, director of the Yale University School of Medicine Prevention Research Center, said sexually transmitted diseases are a considerable public health burden.

"By serving up crucial details on where and in whom sexually transmitted diseases are most likely, this report helps inform disease-control programs. By highlighting the persistent prevalence of these diseases, it also issues a call to action," he said.

More information

To learn more about sexually transmitted disease, visit the U.S. Centers for Disease Control and Prevention.

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