Texas can cut off funding to Planned Parenthood's family planning programs for poor women, a state judge ruled Monday.
Judge Gary Harger said that Texas may exclude otherwise qualified doctors and clinics from receiving state funding if they advocate for abortion rights.
The state has long banned the use of state funds for abortion, but had continued to reimburse Planned Parenthood clinics for providing basic health care to poor women through the state's Women's Health Program. The program provides check-ups and birth control to 110,000 poor women a year, and Planned Parenthood clinics were treating 48,000 of them.
Planned Parenthood's lawsuit to stop the rule will still go forward, but the judge decided Monday that the ban may go into effect for now. In seeking a temporary restraining order, Planned Parenthood's patients could have continued to see their current doctors until a final decision was made.
"We are pleased the court rejected Planned Parenthood's latest attempt to skirt state law," attorney general spokeswoman Lauren Bean said. "The Texas Attorney General's office will continue to defend the Texas Legislature's decision to prohibit abortion providers and their affiliates from receiving taxpayer dollars through the Women's Health Program."
Ken Lambrecht, president and CEO of Planned Parenthood of Greater Texas, said he brought the lawsuit on behalf of poor women who depend on its clinics.
"It is shocking that once again Texas officials are letting politics jeopardize health care access for women," Lambrecht said. "Our doors remain open today and always to Texas women in need. We only wish Texas politicians shared this commitment to Texas women, their health, and their well-being."
Planned Parenthood has brought three lawsuits over Texas' so-called "affiliate rule," arguing it violates the constitutional rights of doctors and patients while also contradicting existing state law.
Republican lawmakers who passed the affiliate rule last year have argued that Texas is an anti-abortion state, and therefore should cut off funds to groups that support abortion rights. Gov. Rick Perry, who vehemently opposes abortion, has pledged to do everything legally possible to shut down Planned Parenthood in Texas and welcomed the court's ruling.
"Today's ruling finally clears the way for thousands of low-income Texas women to access much-needed care, while at the same time respecting the values and laws of our state," Perry said. "I applaud all those who stand ready to help these women live healthy lives without sending taxpayer money to abortion providers and their affiliates."
The Texas Health and Human Services Commission has spent the last nine months preparing to implement the affiliate rule. But federal officials warned it violated the Social Security Act and cut off federal funds for the Women's Health Program, prompting the commission to start a new program using only state money.
State officials have also scrambled to sign up new doctors and clinics to replace Planned Parenthood. Women who previously went to Planned Parenthood clinics will now have to use the agency's web site to find a new state-approved doctor.
On Friday, HHSC officials acknowledged they are unsure whether the new doctors can pick up Planned Parenthood's caseload in all parts of the state.
Linda Edwards Gockel, a spokesman for the Texas Health and Human Services Commission, said Monday that the new state program will launch as planned on Tuesday.
"We have more than 3,500 doctors, clinics and other providers in the program and will be able to continue to provide women with family planning services while fully complying with state law," she said. "We welcome Planned Parenthood's help in referring patients to providers in the new program."
Democratic lawmakers continued to question whether women will have to wait longer for appointments and services.
"I vehemently disagree with the state's efforts to blacklist a qualified provider and, thereby, interfere with a woman's right to choose her own provider," said state Rep. Donna Howard, D-Austin. "I will be submitting a letter to the Texas Health and Human Services Commission, requesting a list of approved providers to gauge the outreach of the new program, and ensure that all qualified women throughout the state have access to its services."
Another hearing is scheduled with a different judge for Jan. 11, where Planned Parenthood will again ask for an injunction to receive state funding.
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The Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.
The agency approved J&J's pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.
Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.
Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.
The standard drugs used to fight the disease were developed in the 1950s and 1960s.
"The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have," said Chrispin Kambili, global medical affairs leader for J&J's Janssen division.
The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.
"Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, director of the FDA's antibacterial drugs office. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."
Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.
Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.
Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.
"The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval," the group states. "But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug."
The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.
Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.
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Poor Larry isn't looking too good. He's pale and clammy and he's been projectile vomiting over and over again while his carers just stand by and watch.
Yet their lack of concern for Larry is made up for by their intense interest in how far splashes of his vomit can fly, and how effectively they evade attempts to clean them up.
Larry is a "humanoid simulated vomiting system" designed to help scientists analyze contagion. And like millions around the world right now, he's struggling with norovirus - a disease one British expert describes as "the Ferrari of the virus world".
"Norovirus is one of the most infectious viruses of man," said Ian Goodfellow, a professor of virology at the department of pathology at Britain's University of Cambridge, who has been studying noroviruses for 10 years.
"It takes fewer than 20 virus particles to infect someone. So each droplet of vomit or gram of feces from an infected person can contain enough virus to infect more than 100,000 people."
Norovirus is hitting hard this year - and earlier too.
In Britain so far this season, more than a million people are thought to have suffered the violent vomiting and diarrhea it can bring. The Health Protection Agency (HPA) said this high rate of infection relatively early in the winter mirrors trends seen in Japan and Europe.
"In Australia the norovirus season also peaks during the winter, but this season it has gone on longer than usual and they are seeing cases into their summer," it said in a statement.
In the United States, the Centers for Disease Control and Prevention (CDC) say norovirus causes 21 million illnesses annually. Of those who get the virus, some 70,000 require hospitalization and around 800 die each year.
Profuse and projectile
Norovirus dates back more than 40 years and takes its name from the U.S. city of Norwalk, Ohio, where there was an outbreak of acute gastroenteritis in school children in November 1968.
Symptoms include a sudden onset of vomiting, which can be projectile, and diarrhea, which may be profuse and watery. Some victims also suffer fevers, headaches and stomach cramps.
John Harris, an expert on the virus at Britain's HPA, puts it simply: "Norovirus is very contagious and very unpleasant."
What makes this such a formidable enemy is its ability to evade death from cleaning and to survive long periods outside a human host. Scientists have found norovirus can remain alive and well for 12 hours on hard surfaces and up to 12 days on contaminated fabrics such as carpets and upholstery. In still water, it can survive for months, maybe even years.
At the Health and Safety Laboratory in Derbyshire, northern England, where researcher Catherine Makison developed the humanoid simulated vomiting system and nicknamed him "Vomiting Larry", scientists analyzing his reach found that small droplets of sick can spread over three meters.
"The dramatic nature of the vomiting episodes produces a lot of aerosolized vomit, much of which is invisible to the naked eye," Goodfellow told Reuters.
Larry's projections were easy to spot because he had been primed with a "vomitus substitute", scientists explain, which included a fluorescent marker to help distinguish even small splashes - but they would not be at all easily visible under standard white hospital lighting.
Add the fact that norovirus is particularly resistant to normal household disinfectants and even alcohol hand gels, and it's little wonder the sickness wreaks such havoc in hospitals, schools, nursing homes, cruise ships and hotels.
During the two weeks up to December 23, there were 70 hospital outbreaks of norovirus reported in Britain, and last week a cruise ship that sails between New York and Britain's Southampton docked in the Caribbean with about 200 people on board suffering suspected norovirus.
The good news, for some, is that not everyone appears to be equally susceptible to norovirus infection. According to Goodfellow, around 20 percent of Europeans have a mutation in a gene called FUT2 that makes them resistant.
For the rest the only likely good news will have to wait for the results of trials of a potential norovirus vaccine developed by U.S. drugmaker LigoCyte Pharmaceuticals Inc, or from one of several research teams around the world working on possible new antiviral drugs to treat the infection.
Early tests in 2011 indicated that around half of people vaccinated with the experimental shot, now owned by Japan's Takeda Pharmaceutical Co, were protected from symptomatic norovirus infection.
The bad news, virologists say, is that the virus changes constantly, making it a moving target for drug developers. There is also evidence that humans' immune response to infection is short-lived, so people can become re-infected by the same virus within just a year or two.
"There are many strains, and the virus changes very rapidly - it undergoes something virologists call genetic drift," Harris said in a telephone interview. "When it makes copies of itself, it makes mistakes in those copies - so each time you encounter the virus you may be encountering a slightly different one."
This means that even if a vaccine were to be fully developed - still a big 'if' - it would probably need to be tweaked and repeated in a slightly different formula each year to prevent people getting sick.
Until any effective drugs or vaccines are developed, experts reckon that like the common cold, norovirus will be an unwelcome guest for many winters to come. Their advice is to stay away from anyone with the virus, and use soap and water liberally.
"One of the reasons norovirus spreads so fast is that the majority of people don't wash their hands for long enough," said Goodfellow. "We'd suggest people count to 15 while washing their hands and ensure their hands are dried completely."
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The Secretary of State has been undergoing treatment for a blood clot just below her ear that was reportedly caused by the concussion she suffered in mid-December. She is expected to make a complete recovery. NBC News chief science correspondent Robert Bazell reports.
Secretary of State Hillary Clinton was admitted to a New York City hospital on Sunday after doctors discovered that a blood clot had formed, the State Department said in a statement.
Philippe Reines, a deputy assistant secretary, said in the statement that the clot stems from a concussion Clinton sustained several weeks ago.
Reines said that Clinton, 65, is being treated with anticoagulants at NewYork-Presbyterian Hospital in Manhattan. She will be monitored there for the next 48 hours, he said.
“Her doctors will continue to assess her condition, including other issues associated with her concussion," he said. "They will determine if any further action is required.”
Dr. Roshini Raj, a physician at New York University Medical Center and a contributor to the TODAY show, says it’s not at all clear where Clinton’s blood clot is – which is important for understanding how serious her medical condition is.
“It’s a little murky,” Raj told TODAY. It is uncommon for a concussion alone to cause a blood clot. More likely is a blood clot elsewhere from lying in bed to recover from a concussion, Raj said.
Dr. Roshini Raj, an attending physician at NYU Medical Center, speaks with TODAY's Willie Geist about Hillary Clinton's blood clot complication, how common it is and what it may mean for her health going forward.
Clinton suffered the concussion from fainting earlier in December. She had been sick for several days with the flu and had canceled a trip to Morocco where she was to officially recognize the Syrian rebels.
Brain injury doctors told NBC News said that although details haven't been made public, initial reports indicate that Clinton may have developed a blood clot in her lower limbs as a result of prolonged rest and inactivity after her recent concussion.
A deep vein thrombosis, known as a DVT, or a dural venous sinus thrombosis, could be two types of blood clots treated with anticoagulants, said Dr. Alex Valadka, a spokesman for the American Association of Neurological Surgeons. A blood clot could be dangerous if it breaks free and lodges in a vital organ, such as the heart.
Kevin Lamarque / Reuters file
Clinton, photographed here on Dec. 6 at Dublin City University, canceled a trip to Morocco earlier this month after a bout of flu. She was hospitalized Sunday after doctors discovered a blood clot stemming from a concussion she sustained earlier in the month.
A deep vein thrombosis could be serious, but not necessarily life-threatening, and would require months of treatment with blood-thinning drugs, said Dr. Inam Kureshi, chief of neurosurgery at Hartford Hospital in Hartford, Conn.
"Usually hospitalization is more of a precaution," Kureshi said.
Kevin Lamarque / Reuters
Hillary Clinton's life has taken her from first lady to senator to secretary of state.
It is possible that Clinton developed a blood clot elsewhere, including her brain. Doctors interviewed would not speculate about treatment or prognosis for the secretary of state.
Days after she fainted, State Department officials said she was at home recovering. Officials also issued a statement from Dr. Lisa Bardack of Mount Kisco Medical Group and Dr. Gigi El-Bayoumi of George Washington University that provided more information about the secretary's condition:
"Secretary Clinton developed a stomach virus, leading to extreme dehydration, and subsequently fainted. Over the course of this week we evaluated her and ultimately determined she had also sustained a concussion. We recommended that the Secretary continue to rest and avoid any strenuous activity, and strongly advised her to cancel all work events for the coming week. We will continue to monitor her progress as she makes a full recovery."
It wasn’t the first time Clinton passed out while sick with a stomach bug. As a U.S. senator representing New York, Clinton fainted in 2005 during a speech in Buffalo after complaining of a stomach virus.
NBC's Robert Bazell tells MSNBC's Chris Jansing that it is unclear how severe the blood clot could be for the health of Sec. of State Hillary Clinton, given lack of specific information about her condition on Sunday evening.
NBC's JoNel Aleccia and Isolde Raftery contributed reporting.
Daily recess, it seems, is going the way of the dinosaurs – but it shouldn’t, the nation’s pediatricians say.
As more and more grade schools drop this time-honored break from their schedules, members of the American Academy of Pediatrics are speaking out in hopes of reversing the trend, pointing to recess’s benefits to both learning and health.
In a position statement released Monday in the journal Pediatrics, the AAP laid out the scientific evidence showing that kids need daily recess to keep them mentally sharp and physically healthy.
“Every school needs to find a way for recess to happen for every child,” says the paper’s co-author Catherine Ramstetter, a health educator at The Christ College of Nursing and Health Sciences in Cincinnati. “And it shouldn’t be something that is taken away because a kid forgot to bring his homework.”
Yet 77 percent of nearly 2,000 principals surveyed in a 2009 Gallup poll on recess, sponsored by the Robert Wood Johnson Foundation, reported withholding recess from children as punishment. The Gallup report, called "The State of Play," also noted that one in four elementary schools no longer provides recess to all grades.
Unfortunately, Ramstetter says, recess has been an easy target for school administrators who are afraid of lawsuits over playground accidents and who feel pressured to improve academic performance by adding more instruction time. That approach is just wrong-headed, she says.
“We hope to encourage parents to make the case that recess helps with education,” Ramstetter says. “Research shows that children who take a break are more ready to be learning.”
In fact, studies have shown that kids are more attentive and productive when they get a break from academics, Ramstetter notes. And while some educators would like to believe that moving from math class to reading constitutes a break, Ramstetter says, “shifting from numbers to words isn’t enough. That’s just a shift in the kind of demands.”
The downtime recess provides gives kids’ brains a rest and also a chance to think more creatively, Ramstetter says. And for antsy kids, recess can be a time to blow off steam, allowing them to focus better when classes resume.
And then there’s the issue of the growing childhood obesity epidemic.
Ramstetter and her colleagues note that many kids benefit from exercise during recess. “Even minor movement during recess counterbalances sedentary time at school and at home and helps the child achieve the recommended 60 minutes of moderate to vigorous activity per day ... which can help lower the risk of obesity.”
That makes a lot of sense to Arthur Weltman, a professor and director of the exercise physiology program at the University of Virginia.
Kids these days are frighteningly sedentary, Weltman says. And that’s going to haunt us some 20 years from now in terms of health care costs.
Further, Weltman says, “there’s a lot of data indicating that increased physical activity in children not only improves health, but also increases learning. There is data showing that kids who get recess do better on standardized tests and that teachers perceive them as paying better attention.”
If you look at countries known for excellent academics, you won’t see them cutting out recess, Weltman says. The Japanese, for example, give their kids a 15 minute break every hour.
Child development expert, Alan Kazdin, says the Pediatrics report’s only flaw is that it didn’t go far enough. Cutting back on recess is “misguided,” says Kazdin, the John M. Musser professor of Psychology and Child Psychiatry at Yale University. “There are such enormous benefits from exercise, at the cellular level and for diverse facets of mental health.”
All school, no play? Kids' learning suffers without recess
CHICAGO (Reuters) - After his first day working at St Joseph Mercy Ann Arbor hospital's newly created Fungal Outbreak Clinic, Dr David Vandenberg struggled to describe to his boss the enormity of what lay ahead. He settled on a line from the movie Jaws.
Rebecca Cook / REUTERS
Bonita Robbins, a patient suffering with arachnoiditis due to a contaminated steroid injection, sits on her hospital bed as she and her husband Ed listen to Infectious diseases Dr. Anurag Malani at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Mich.
"We're going to need a bigger boat," Vandenberg told Dr Lakshmi Halasyamani, chief medical officer of the Michigan hospital, echoing the film's local police chief after he first eyes a 25-foot (7.5-metre) killer shark.
The St Joseph Mercy clinic has been at the front line of the fight against one of the biggest ever U.S. outbreaks of fungal meningitis, a killer infection that has been traced to tainted steroid shots from a Massachusetts pharmacy.
So far, 620 Americans have developed serious infections related to the outbreak, including 367 cases of deadly meningitis, and 39 people have died. Of the 19 U.S. states affected, Michigan has been worst hit, handling more than one third of the total cases in the outbreak.
St Joseph Mercy - a 537-bed Catholic hospital located in Ypsilanti, on the doorstep of the University of Michigan - has treated 169 of the state's 223 cases of infections that can cause meningitis, including 7 people who died.
At one point it was so overrun that 87 of its 537 beds, which are usually occupied by patients with cancer or heart ailments and the like, were occupied by patients with fungal meningitis and related infections.
Dr Tom Chiller, the fungal disease expert at the U.S. Centers for Disease Control and Prevention, who has been overseeing the outbreak, praised the work of the hospital in helping to limit deaths from the outbreak.
"They have been incredibly creative in dealing with these complicated patients," he said.
In all, almost 14,000 people seeking relief from back and joint pain received injections from moldy steroid shots made at the now-bankrupt New England Compounding Center in Massachusetts before they were recalled in late September.
CDC experts initially feared death rates in the 40 to 50 percent range; instead, only about 6 percent of those infected have died, and the CDC credits the creative and dogged efforts of state and local health officials for keeping the death rates so low.
The first wave of the outbreak involved the most severe cases of meningitis - an inflammation of the membranes that cover the brain and spinal cord. But starting in mid-October, patients who had been recovering from meningitis were developing potentially fatal localized infections near the site where contaminated drug was injected to treat back or neck pain.
As they started seeing more cases of these local, secondary infections, the staff at St Joseph's devised a bold plan to screen all patients in their database looking for potential new infections that might have been missed in the first wave.
On December 20, the CDC issued an alert to doctors incorporating some of lessons learned by the efforts of doctors at St Joseph's and other hospitals, calling for increased screening of patients who may be harboring localized infections.
A bewildering fungi
Among the patients who developed secondary infections was Bonita Robbins, a 72-year-old retired nurse from Pinckney, Michigan, who received doses of the tainted drug at the Michigan Pain Specialists clinic in the nearby town of Brighton while seeking relief for lower-back pain.
The first shot brought some relief, the second did little to ease her aches, and the third was contaminated. In October, Robbins went to St Joseph's with a severe headache, back pain and pain in her thighs.
She spent 37 days in the hospital taking two kinds of antifungal drugs.
Dr Anurag Malani, an infectious disease specialist treating Robbins, said the challenge with the outbreak was that there was no medical literature to fall back on.
"No one has ever seen anything of this magnitude related to fungal infections, ever," he said.
Chiller said U.S. doctors had never treated meningitis caused by Exserohilum rostratum, the environmental mold causing most of the infections.
"It's just a rare, rare cause of infection." Seeing that mold in the meninges - membranes covering the brain and spinal cord - is "completely new."
Initially, St Joseph's Fungal Outbreak Clinic was started in order to coordinate the care of patients after their discharge, which included overseeing the administration of a complex regime of anti-fungal drugs.
It morphed into something bigger when some of its 53 patients with meningitis started returning with infections near the site in their back or neck where the contaminated drug was injected.
Then came a wave of patients like Robbins, who had been ruled out for meningitis with a spinal tap, but were still complaining of pain near their injection site.
Getting the "bigger boat"
"When it became obvious that the number of patients would be a much higher percentage than anticipated by the CDC, we expanded our clinic and started enlisting the help of several other hospitals," Vandenberg said.
Many of the patients had spinal abscesses, an infection in the space between the outside covering of the spinal cord and the bones of the spine. Others developed arachnoiditis, an infection of nerves within the spinal canal.
The decision to screen all patients in the hospital database who might have received tainted injections was not taken at the recommendation of the CDC.
"That was our own decision," said Vandenberg, a specialist in internal medicine overseeing the screening effort.
He admitted that the strategy was aggressive, but said that, especially early on, doctors feared the local infections might be precursors to meningitis, making catching them early a potentially life-saving move.
Excluding patients who had already been screened and those who had injections in areas other than the spine, the hospital targeted about 500 patients for MRI scans.
Most so far have had private insurance that covers the screening. For the uninsured, the hospital's Patient Financial Services department has been helping them to apply for financial support.
"We did over 400 MRIs in about a 4-week period," Vandenberg said. The hospital screened so many patients, in fact, that the state of Michigan sent in an emergency mobile MRI unit to help.
Vandenberg got the task of reading stacks of MRI reports, sometimes as many as 30 a day.
So far, about 20 percent of the MRIs have shown up as abnormal, meaning that patients have to come back for surgery and treatment.
Vandenberg makes all of those calls personally. Not all of them go smoothly. He likens the gravity of the conversation - learning you have a potentially deadly new disease that requires months of treatment with risky drugs - to telling someone they have cancer.
After one especially tough call, in which a heart patient feared he would not survive the surgery he would need to clear his infection, Vandenberg cracked.
"I started crying. I probably haven't cried for 15 years."
Signs outbreak is easing
But at last, after months of onslaught, there are signs the outbreak is easing.
Attendance at the hospital's daily support group has begun to taper off. And since the beginning of December, more than 50 patients with fungal infections have been discharged, while only 20 have been admitted, bringing the total number of fungus-related inpatient to 30.
Vandenberg nevertheless cautions that the outbreak is still far from over.
"Every single day of this screening program, we're finding one or two cases that are abnormal and need to be admitted," he said.
Vandenberg gave the CDC access to the clinic's database so the agency could see how the effort turned out, and this month, the CDC issued the alert to doctors incorporating some of the results of the MRI screening program.
The alert warned that some patients who got tainted injections but did not develop meningitis may still be at risk of localized infections.
And it urged doctors to consider ordering an MRI for all patients who still have pain, even if the pain is similar to what sent them in for treatment in the first place.
Chiller said the United States had not yet reached the end of the outbreak.
"Unfortunately, with fungi, the incubation periods are so long and they can remain indolent. I'm definitely concerned that we're going to continue to see more cases."
(Reporting by Julie Steenhuysen; Editing by Jilian Mincer, Mary Milliken and David Brunnstrom)
The discovery that a protein which triggers milk production in women may also be responsible for making breast cancers aggressive could open up new opportunities for treatment of the most common and deadliest form of cancer among women.
Found in all breast cells, the protein ELF5 tries to activate milk production even in breast cancer cells, which does not work and then makes the cancer more aggressive, according to scientists in Australia and Britain.
"The discovery opens up new avenues for therapy and for designing new markers that can predict response to therapy," said lead author Professor Chris Ormandy from the Garvan Institute of Medical Research in Sydney.
In 2008, Ormandy's work linked ELF5 to milk production.
The latest research by Ormandy and his team, published in the journal PLOS Biology on Friday, went a step further to find the link between ELF5 and breast cancer.
"Cancer cells can't respond properly (to ELF5), so they ... acquire some characteristics ... that make the disease more aggressive and more refractory (resistant) to treatment with existing therapies," Ormandy said by telephone.
Ormandy and his team grew human breast cancer tissues, genetically manipulated to contain high amounts of ELF5, in petri dishes and saw how the protein proliferated aggressively.
Findings may help targeted therapy
Breast cancer is the most commonly diagnosed cancer and the top cause of cancer death among women, accounting for 23 percent of total cancer cases and 14 percent of cancer deaths in women.
To decide on treatment, doctors normally need to find out if the cancer has receptors for the hormones estrogen and progesterone, which, in the case of breast cancer patients, promote growth in their tumors.
Two-thirds of breast cancers are usually positive for estrogen receptors, which then require anti-hormonal therapies that lower estrogen levels in the patient or block estrogen from supporting the growth of the cancer.
For the remaining one-third of patients, their cancers do not have receptors, which means they won't benefit from hormonal therapies. Such patients are usually given other treatments, such as chemotherapy.
Ormandy's team found that cancers with these receptors had low levels of ELF5, while those without receptors had significantly higher levels of the protein.
"What we have shown in this paper is high ELF5 tumors are dependent on ELF5 for their proliferation and if we block ELF5 in high ELF5 tumors, we will block proliferation and that will treat the tumor," Ormandy said.
"If we can develop a drug that targets ELF5, it will be very useful for that group of women," he said.
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Two big events recently took place in the world of food: The Food and Drug Administration decreed that genetically engineered salmon wouldn't harm the environment and McDonald’s announced that its McRib sandwich is back on the menu.
The FDA’s announcement paves the way for the first approval of a genetically engineered animal for humans to eat – and it was met with a good deal of highly critical wailing and groaning by Consumer’s Union, National Geographic and many other advocacy groups who are wary of genetically engineered food.
The McRib’s return was greeted with a few snickers by late night comedians and overwhelmingly happy faces on the millions of Americans who eat at one of the 13,000 McDonald’s restaurants from Maine to Hawaii every day. This, as my grandmother would have said in Yiddish, is “fakakta”—completely screwy.
If you like salmon, and I do, should you worry much about the safety of eating genetically engineered salmon? No. The FDA said it could not find any valid scientific reason to prohibit the sale of the fish.
If you like the McRib, and I do, should you worry a lot about eating it? Oh yeah.
The genetically altered “AquAdvantage”’ salmon is Atlantic salmon made from an egg, which has been injected with a gene from a Chinook salmon. That gene, which is stuck to a bit of DNA from another fish—the ocean pout, carries instructions for making more growth hormone than an Atlantic salmon ordinarily makes. More growth hormone means faster growth and, thus, more salmon to eat much more quickly.
This genetic concoction was first used in 1989, to create a “founder” genetically modified (GM) salmon. The GM salmon is now in its tenth generation. Many people have eaten it. No nasty side-effects have been observed.
Now consider the McRib sandwich. There is no rib in a McRib. The sandwich features a “McRib pork patty,” contains 980 milligrams of sodium, 26 grams of fat and 23 milligrams of cholesterol. Ingredients listed on the McDonald's website for the McRib’s bun include azodicarbonamide, a flour bleaching agent used in breads at some U.S. fast food restaurants – and also in the making of foamed plastics. It’s banned as a food additive in some countries.
It is time for some straight talk when it comes to genetically engineered foods. Americans are offered a mountain of jumbo-sized salty, fatty food every day. These foods are killing and disabling them at a very high rate. Making more salmon more cheaply is a far better option than ignoring the crap that too many people are currently eating every day.
Those who claim to be worried about what we eat should worry a lot less about people eating more genetically engineered salmon and a whole lot more about the number of Americans who eat fast food daily. Those who care about public health should not target bigger fish but the drive-thru.
Arthur Caplan, Ph.D., is the head of the Division of Medical Ethics at NYU Langone Medical Center.
Federal health regulators say a genetically modified salmon that grows twice as fast as normal is unlikely to harm the environment, clearing the way for the first approval of a scientifically engineered animal for human consumption.
The Food and Drug Administration on Friday released its environmental assessment of the AquaAdvantage salmon, a faster-growing fish which has been subject to a contentious, years long debate at the agency. The document concludes that the fish "will not have any significant impacts on the quality of the human environment of the United States." Regulators also said that the fish is unlikely to harm populations of natural salmon, a key concern for environmental activists.
The FDA will take comments from the public on its report for 60 days before making it final.
The FDA said more than two years ago that the fish appears to be safe to eat, but the agency had taken no public action since then. Executives for the company behind the fish, Maynard, Mass.-based Aquabounty, speculated that the government was delaying action on their application due to push-back from groups who oppose genetically modified food animals.
Experts view the release of the environmental report as the final step before approval.
"We are encouraged that the environmental assessment is being released and hope the government continues the science-based regulatory process," AquaBounty said in a statement.
If FDA regulators clear the salmon, as expected, it would be the first genetically altered animal approved for food anywhere in the world.
Critics call the modified salmon a "frankenfish." They worry that it could cause human allergies and the eventual decimation of the natural salmon population if it escapes and breeds in the wild. Others believe breeding engineered animals is an ethical issue.
AquaBounty has maintained that the fish is safe and that there are several safeguards against environmental problems. The fish would be bred female and sterile, though a very small percentage might still be able to breed. The company said the potential for escape is low. The FDA backed these assertions in documents released in 2010.
Since its founding in 1991, Aquabounty has burned through more than $67 million developing the fast-growing fish. According to its midyear financial report, the company had less than $1.5 million in cash and stock left. It has no other products in development.
Genetically engineered — or GE — animals are not clones, which the FDA has already said are safe to eat. Clones are copies of an animal. In GE animals, the DNA has been altered to produce a desirable trait.
The AquaAdvantage salmon has an added growth hormone from the Pacific Chinook salmon that allows the fish to produce growth hormone all year long. The engineers were able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an "on" switch for the hormone. Typical Atlantic salmon produce the growth hormone for only part of the year.
It is still unclear whether the public will have an appetite for the fish if it is approved. Genetic engineering is already widely used for crops, but the government until now has not considered allowing the consumption of modified animals. Although the potential benefits — and profits — are huge, many people have qualms about manipulating the genetic code of other living creatures.
If the salmon are eventually approved for sale, consumers may not even know they are eating them. According to federal guidelines, the fish would not be labeled as genetically modified if the agency decides it has the same material makeup as conventional salmon. AquaBounty says that genetically modified salmon have the same flavor, texture, color and odor as the conventional fish, and the FDA so far has not shown any signs of disagreeing.
Wenonah Hauter, director of the advocacy group Food and Water Watch, said forgoing labeling not only ignores consumers' rights to know what they are eating, but "is simply bad for business, as many will avoid purchasing any salmon for fear it is genetically engineered."
Hauter urged members of Congress to block the impending approval of the fish. Congressional opposition to the engineered fish has so far been led by members of the Alaska delegation, who see the modified salmon as a threat to the state's wild salmon industry.
Sen. Lisa Murkowski, R-Alaska, said Friday she is working to convince fellow senators that approval for the fish should be stopped.
"This is especially troubling as the agency is ignoring the opposition by salmon and fishing groups, as well as more than 300 environmental, consumer and health organizations," she said of the preliminary approval.
The Connecticut medical examiner has asked scientists to analyze the DNA of Adam Lanza, the 20-year-old who killed 27 people, including his mother, two classrooms full of small children and teachers, before killing himself on Dec. 14.
Investigators hope that studying Lanza's DNA for mutations or other abnormalities may shed some light on the tragedy. Connecticut's chief medical examiner, Dr. H. Wayne Carver II, called the University of Connecticut a few days before Christmas asking for help from the UConn Health Center’s Department of Genetics and Developmental Biology, said UConn spokesman Tom Breen.
“They have agreed to offer any assistance they can to help the chief medical examiner in his investigation,” Breen said. Of Carver, Breen said, “He wanted help in conducting tests relating to genetics involving the shooter in the Newtown massacre.”
Breen said did not know what specific tests would be conducted. He said UConn was happy to help.
“This is such a terrible thing,” Breen said. “Everybody in the state has been affected by this.”
Will a DNA analysis help explain Lanza's rampage?
The study of Lanza's DNA would be for research purposes, not to find a diganosis for his acts, says Arthur Caplan, Ph.D, NBC News contributor and head of Division of Bioethics at New York University Langone Medical Center in New York City. While there has been prior research on genetic mutations and violent behavior, looking at someone’s genes "is like hunting in a DNA haystack," Caplan says.
"We don’t have a database that says there’s a correlation between genes and propenstity to violence or crime or propensity to mental illness," he says. "A particular DNA message may indicate a propensity to behavior, but at best you might find associations to greater risk. You won’t find a gene that says I’m going to be a mass murderer or a terrorist or an assassin."
James Fallon, a neuroscientist at the University of California, Irvine, who studies serial killers and other violent criminals, argues it will be fruitless to try to pin Lanza’s acts on his genes alone. Genetic data only paints part of the picture, he's found.
"The genes by themselves don’t tell you. If you just have a PET scan or MRI you can’t tell," Fallon said last week. "The psych report alone won't tell you. You put those things together you really get a lot of information." And some of what's been found by Fallon and other researchers provides some surprising insights.
Take for instance the “warrior gene”, the monoamine oxidase-A, or MAOA, gene that, has received widespread media attention, said Fallon.
“People know about the warrior gene and that it is associated with psychopaths and with killing,” Fallon said in a telephone interview.
Only a handful of diseases, such as cystic fibrosis, cause symptoms based on a single mutated gene. Most require thousands of changes and interactions. “So the idea that you have the warrior gene, therefore you are a warrior, it doesn’t hack it,” Fallon says.
It takes something more than just a genetic predisposition to make someone violent.
Fallon says there is no scientifically acceptable body of work on the genetics of violent behavior. "I don’t know of a case where even one killer has been studied genetically to an appropriate level, " Fallon said.
Likewise, brain studies have shed some light but can’t explain or predict the most extreme behaviors, said Dr. Martin Teicher, director of the Developmental Biopsychiatry Research Program at Harvard Medical School and McLean Hospital in Massachusetts.
“I don’t think we have the answer from neuroscience,” Teicher said. “Given the millions of people there are, the tiny handful of people who did these things are quite rare … We are drawing generalities from people who have had bad experiences, and who are maybe more prone to get into a fight, but they never would do anything like this.”
There is something that many violent people do have in common, however. Research done by Teicher, Fallon and others shows that violent criminals are, in fact, excessively anxious and fearful.
“Individuals at risk for violence often suffer from tremendous anxiety,” Teicher said. “It’s one of the most striking things I have noticed.” He’s treated high school students expelled or suspended for violence, but when they are in his office, they are anything but threatening.
“These are the frightening children in high school, yet they are essentially sitting in their mother’s laps,” Teicher said. “They were ridden with anxiety.”
And in some cases, this is combined with an inability to “read” other people. Teicher’s found this in some patients.
“We found differences in the (brain) cortex of violence-exposed individuals that play a role in social perception,” Teicher said. “These are regions involved in being able to infer what other people are thinking.” Brain scans show that the blood isn’t flowing normally in those brain regions. “They may be prone to misattribute thoughts and feelings,” Teicher says.
Such deficiencies can be immensely stressful to a young man or teenager, Fallon says. “He looks at people and doesn’t understand what they are feeling,” he said.
On top of this, Teicher has seen differences in parts of the brain’s frontal cortex that are involved in impulse control. “Misreading people and having difficulty controlling impulses may foster inappropriate actions,” Teicher says.
And while schizophrenia or bipolar disease do not usually lead to violent behavior, they can contribute to dangerous acts if patients are also racked with anxiety and not getting any sort of treatment.
“The late teens, early 20s, are when people have these psychotic breaks," Fallon said.
Most young people with these developing psychiatric conditions may feel anxious or threatened, but they don’t actually act on their feelings in part because they are unable to, Fallon said. Studies show the adolescent brain lacks the connections to initiate certain actions.
The brain is still growing, making new connections and cutting unneeded circuits, until the early 20s, Fallon said. The prefrontal cortex, involved in “executive function” or decision-making, is the last part of the brain to mature.
In an anxious young man, unable to understand people around him, perhaps ascribing all sorts of mistaken intentions to others, this could come to a climax, said Fallon, who studies how message-carrying chemicals such as dopamine and norepinephrine act in the brain.
The young man's brain is still growing and changing until, finally, the prefrontal cortex matures. The amygdala, the part of the brain responsible for fear responses on the most basic level, is at the same time being flooded with corticotropin-releasing hormone, which is involved in the brain's stress response.
“He is finally able to take action,” Fallon says. “Now the moment has come for him to carry out the ultimate act. If you turn it around like that, it makes a lot of logical sense."
Lisa Flam contributed to this story.
Nap Nanny seats made by Baby Matters LLC of Berwyn, Pa., pose a 'substantial risk of injury and death to infants,' the Consumer Product Safety Commission said.
Four national retailers agreed to recall more than 150,000 Nap Nanny baby recliners after at least five infant deaths and dozens of reports of children nearly falling out of the recliners, the Consumer Product Safety Commission said Thursday.
The recall covers Nap Nanny Generations One and Two, and the Chill model infant recliners. All were sold between 2009 and 2012. The Nap Nanny was designed to mimic the curves of a baby car seat, elevating an infant slightly to help reduce reflux, gas, stuffiness or other problems.
The CPSC warned parents and caregivers that the Nap Nanny contains defects in its design, warnings and instructions. The agency said the product poses a substantial risk of injury and death to infants.
The four retailers — Amazon.com, Buy Buy Baby, Diapers.com and Toys R Us/Babies R Us — agreed to voluntarily participate in the recall of the Nap Nanny because its manufacturer is unable or unwilling to participate, the government agency said in a statement.
The manufacturer, Baby Matters LLC of Berwyn, Pa., told The Associated Press earlier this month that it had gone out of business. At the time, the company's website carried a statement from owner and founder Leslie Gudel that the company didn't believe the CPSC complaint had merit and that its products were safe when used as instructed.
The first two versions of the foam recliner were recalled in July 2010 after the agency became aware of one death and 22 reports of infants hanging out or falling over the side of the Nap Nanny even though most of the infants had been placed in the recliner's harness. Since then, the agency learned of four more deaths. Four were linked to the first versions of the recliner, and one to the newer model.
Five thousand Nap Nanny Generation One and 50,000 Generation Two models were sold between 2009 and early 2012. About 100,000 Chill models have been sold since January 2011.
The CPSC advised consumers seeking more information about the recall to review the return policies of the retailers participating in the recall.
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The year started in the United States with a mild flu season but ended up being marked by deadly outbreaks of fungal meningitis, West Nile virus and Hantavirus.
Tainted steroid medication has been cited as the cause of the meningitis outbreak that killed 39 people.
Weather contributed to the worst outbreak of West Nile virus since 2003 and an unusual outbreak of Hantavirus in California's Yosemite National Park.
Transmitted by infected mice, Hantavirus is a severe, sometimes fatal syndrome that affects the lungs. West Nile can cause encephalitis or meningitis, infection of the brain and spinal cord or their protective covering.
As of December 11, 5,387 cases of West Nile virus had been reported in 48 states, resulting in 243 deaths, the CDC said in its final 2012 update on the outbreak. The 2003 outbreak left 264 dead from among nearly 10,000 reported cases.
A large number of cases this year occurred in Texas, Louisiana and Mississippi where there are large mosquito populations.
CDC and state officials have said that rainfall in the spring and record high summer temperatures contributed to the severity of the outbreak by affecting mosquito populations, which transmit the disease by biting humans and animals.
Health officials said that only a small percentage of cases of West Nile virus are reported because most people have no symptoms and about 20 percent have mild symptoms such as aches and fever. One in 150 people with West Nile virus develop other illnesses such as meningitis and encephalitis.
The biggest outbreak in nearly two decades of Hantavirus, which emerges in dry and dusty environments, cropped up during the summer in 1,200-square-mile (3,100-square-km) Yosemite National Park, killing three of 10 infected visitors.
The National Park issued warnings to 22,000 people who may have been exposed to the rare disease, and 91 Curry Village cabins in the park were closed in late August.
In early September, a 78-year-old judge named Eddie Lovelace was rushed to a hospital in Nashville, Tennessee. Thought to have had a stroke, he died a few days later.
After a large outbreak of fungal meningitis was linked to tainted steroid injections, Lovelace's cause of death was revised. He became the first documented death in a meningitis outbreak that has infected 620 people and killed 39 in 19 states.
The New England Compounding Center in Framingham, Massachusetts, was closed after investigators found that it had shipped thousands of fungus-tainted vials of methylprednisolone acetate to medical facilities around the United States. The steroid was typically used to ease back pain.
More than 14,000 people were warned that they may have had an injection of the tainted steroid. Doctors continue to see new cases of spinal infections related to the steroid, and cases of achnoiditis, an inflammation of nerve roots in the spine.
The outbreak led two Democratic lawmakers in the U.S. House of representatives to introduce legislation to increase government oversight of compounded drugs.
And what lies ahead in 2013?
"While there are some trends we can predict, the most reliable trend is that the next threat will be unpredictable," said Centers for Disease Control and Prevention (CDC) Director Thomas Frieden.
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For scientists, an answer to a question, or solution to a problem, is not true until proven so. And sometimes that means revealing what mere mortals already knew, like, say the fact that getting to the hospital quicker can save heart-attack victims, or, the seemingly far-fetched idea that exercise is good for you.
Here are a few of the most obvious findings of 2012.
1. Good partners make good parents
Perhaps not the most shocking news in the world: Marry a good, secure partner, and you can expect them to become a good, secure parent.
The same skills that make people good in romantic relationships make them good at building relationships with their kids, researchers reported Dec. 6 in the journal Personality and Social Psychology Bulletin. Among the key traits are cooperation and communication. [10 Scientific Tips for Raising Happy Kids]
While this may seem self-evident, researchers say that empirically linking the same skills to the two types of relationships may translate to better self-help and therapy. Fix one relationship, and you may fix them both.
2. We all want to date a hottie
Sure, you may say you look for a good sense of humor and a sweet disposition, but deep down, you have to admit a pretty face wouldn't go amiss.
Both men and women unconsciously desire a sexually attractive partner, a study released in January found.
Using a high-speed word association test, the researchers found that people responded faster to words linked to sexiness, no matter how low they claimed to prioritize the physical. The mismatch between what we say we want and what we want may be why online dating meet-ups sometimes go astray, the researchers said.
3. Pre-gamers drink more
Do the math: If you drink before you go out and then drink while you go out, you end up drinking more than if you hadn't had anything to drink before you went out. In other words, those who "pre-game" get drunker than those who just belly up to the bar, according to research published online in the journal Alcoholism: Clinical & Experimental Research.
"Pre-drinking is a pernicious drinking pattern that is likely to lead people to cumulate two normal drinking occasions — one off-premise followed by one on-premise — and generally results in excessive alcohol consumption," study researcher Florian Labhart of Addiction Switzerland, where the study was conducted, said in a statement. "Excessive consumption and adverse consequences are not simply related to the type of people who pre-drink, but rather to the practice of pre-drinking itself."
4. People with more experience make better decisions
Okay, so pre-drinking is a bad decision — and thus, a choice the more experienced would automatically avoid, according to a study released in December in the journal Organizational Decision Making and Human Decision Processes. People with more experience in a field (in this case, basketball or designer goods), were better at making intuitive judgments about that field than newbies, the study found. But the experienced were no better at making decisions than amateurs when told to reason out their choices analytically. In other words, it’s okay to go with your gut — but only if you know what you're talking about.
5. Keeping guns out of the hands of troubled individuals saves lives
In a report that would tragically prove very timely this year, the Johns Hopkins School of Public Health found that keeping guns away from high-risk individuals prevents gun violence. These individuals include criminals, those with a history of domestic violence, the mentally ill, people under age 21 and substance abusers.
The report also found that the availability of high-capacity magazines increased deaths in mass shootings.
"Mass shootings bring public attention to the exceptionally high rate of gun violence in the U.S., but policy discussions rarely focus on preventing the daily gun violence that results in an average of 30 lives lost every day," said study author Daniel Webster, the director of the Johns Hopkins Center for Gun Policy and Research. "Addressing weaknesses in existing gun laws by expanding prohibitions for criminals, perpetrators of domestic violence, youth, and drug abusers, and closing the loopholes that allow prohibited persons to obtain guns can be effective strategies to reduce gun violence. It is important to note that making these changes to our gun laws would not disarm law-abiding adults."
6. Exercise is good for you
If you haven't heard by now that getting moving is good for you, you might want to get with the times. Perhaps also not new news to those who enjoy a good endorphin buzz: Exercise improves mental health as well as physical.
A study published in the journal Clinical Psychological Science in September found that both the improved body image that came with exercise and the social interaction inherent in organized sports made teens less likely to suffer from mental problems such as depression, anxiety or substance abuse. The study controlled for factors such as socioeconomic background, age and gender.
7. Calling an ambulance improves heart attack survival
Think you're having a heart attack? Dial 911. Believe it or not, paramedics really do save lives.
Research presented at the Acute Care Cardiac Congress in October found that only 29 percent of Turkish patients having heart attacks went to the hospital by ambulance, despite the fact that this service is free in Turkey. Taking a cab or driving one's own car was slower than an ambulance ride and delayed crucial treatment, the study found.
8. Guys are more into their girl friends than vice versa
Apparently some stereotypes about guys and sex are true. It turns out that college-age guys report more sexual interest in their platonic female friends than vice versa, though these crushes are usually described as more of a burden than a boon.
In post-college-age adults, about half of the participants in the study, which was released in May, spontaneously mentioned attraction as a burden to their cross-sex friendships. Nevertheless, study researchers said, male-female friendships can be successful.
9. Smoking a lot of pot can make your mind fuzzy
Yes, science has done it again: Heavy marijuana use can mess with a teen's brain. The study, detailed in the Proceedings of the National Academy of Sciences, found that of the 1,000 New Zealanders followed, those who started using pot as teenagers and used it for years afterward lost some of their smarts; more specifically, they had an average decline in IQ of 8 points, between age 13 and age 38.
"The simple message is that substance use is not healthy for kids," study researcher Avshalom Caspi, a psychologist at Duke University and the Institute of Psychiatry at King's College London, said in a statement. "That's true for tobacco, alcohol, and apparently for cannabis."
10. Driving when drunk is unsafe
Drinking and driving really is dangerous. A study out this year showed that as a person's blood-alcohol level increased so did their risk of being killed or involved in a fatal crash, regardless of their age. For instance, compared with sober drivers of the same age, individuals who were ages 16 to 20 with a blood alcohol between 0.02 and 0.05 were nearly three times as likely to be involved in a fatal crash. The study, detailed in May in the Journal of Studies on Alcohol and Drugs, also found that more underage females who have been drinking alcohol are at risk for being in a fatal car crash compared with 2007. The researchers aren't sure what's behind the increase, but speculate girls are taking more risks nowadays.
11. High heels are bad for your feet
Cramming your feet into tight-fitting shoes with inches-long heels on the bottom can hurt your feet. The new finding out this year? High heel-wearing is linked to ingrown toenails. So who would've guessed that wearing tight-fitting shoes with a steep slope down is one of the most common causes a foot problem in which the toes get compressed so much that the big toenail grows into the skin? But seriously, while often an ingrown nail is just an annoyance, it can get infected and even require surgical removal of the entire nail.
To avoid the pesky podiatry problem, Rodney Stuck, a professor of podiatry at the Loyola University Health System, recommended buying less-tight-fitting heels (yes), and ditching the fashion statements on days when you plan to do a lot of walking and standing.
12. Screaming at your child is harmful to your child
Psychological child abuse, such as belittling, terrorizing, exploiting and neglecting emotionally, can damage a kid's health.
"We are talking about extremes and the likelihood of harm, or risk of harm, resulting from the kinds of behavior that make a child feel worthless, unloved or unwanted," Dr. Harriet MacMillan of McMaster University said in a statement. MacMillan added that examples would include a mother leaving her infant alone in a crib all day or a father pulling his teen into his own drug habit. Such abuse can be as harmful to children as physical harm, the researchers reported in August in the journal Pediatrics.
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Marijuana (cannabis) use may be linked to the development of psychotic symptoms in teens -- but the reverse could also be true: psychosis in adolescents may be linked to later pot use, according to a new Dutch study.
"We have focused mainly on temporal order; is it the chicken or the egg? As the study shows, it is a bidirectional relationship," wrote the study's lead author Merel Griffith-Lendering, a doctoral candidate at Leiden University in The Netherlands, in an email to Reuters Health.
Previous research established links between marijuana and psychosis, but scientists questioned whether pot use increased the risk of mental illness, or whether people were using pot to ease their psychotic symptoms, such as hallucinations and delusions.
"What is interesting in this study is that both processes are going on at the same time," said Dr. Gregory Seeger, medical director for addiction services at Rochester General Hospital in upstate New York.
He told Reuters Health that researchers have been especially concerned about what tetrahydrocannabinol (THC), the active property in pot, could do to a teenager's growing brain.
"That's a very vulnerable period of time for brain development," and individuals with a family history of schizophrenia and psychosis seem to be more sensitive to the toxic effects of THC, he said.
A 2010 study of 3,800 Australian teenagers found that those who used marijuana were twice as likely to develop psychosis compared to teens who never smoked pot.
But that study also found that those who suffered from hallucinations and delusions when they were younger were also more likely to use pot early on.
Chicken v. egg
For the new study, published in the journal Addiction, the researchers wanted to see which came first: pot or psychosis.
Griffith-Lendering and her colleagues used information on 2,120 Dutch teenagers, who were surveyed about their pot use when they were about 14, 16 and 19 years old.
The teens also took psychosis vulnerability tests that asked - among other things - about their ability to concentrate, their feelings of loneliness and whether they see things other people don't.
Overall, the researchers found 940 teens, or about 44 percent, reported smoking pot, and there was a bidirectional link between pot use and psychosis.
For example, using pot at 16 years-old was linked to psychotic symptoms three years later, and psychotic symptoms at age 16 were linked to pot use at age 19.
This was true even when the researchers accounted for mental illness in the kids' families, alcohol use and tobacco use.
Griffith-Lendering said she could not say how much more likely young pot users were to exhibit psychotic symptoms later on.
Also, the new study cannot prove one causes the other. Genetics may also explain the link between pot use and psychosis, said Griffith-Lendering.
"We can say for some people that cannabis comes first and psychosis comes second, but for some people they have some (undiagnosed) psychosis (and) perhaps cannabis makes them feel better," said Dr. Marta Di Forti, of King's College, London, who was not involved with the new research.
Di Forti, who has studied the link between pot and psychosis, told Reuters Health she considers pot a risk factor for psychosis - not a cause.
Seeger, who was also not involved with the new study, said that there needs to be more public awareness of the connection.
"I think the marijuana is not a harmless substance. Especially for teenagers, there should be more of a public health message out there that marijuana has a public health risk," he said.
"Given the severity and impact of psychotic disorders, prevention programs should take this information into consideration," she said.
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New research shows that injecting dermal filler into the buttocks of 80-year-olds fools the skin cells into acting more like the rear end shown here.
The elderly may have more than just years of wisdom to share with us. Their elderly bottoms may help crack the code of aging skin.
In a small study on octogenarians just published in the Journal of Investigative Dermatology, researchers found that dermal fillers do more than plump up the skin, they can make it act younger.
Researchers looking for ways to help thin, aging skin to heal after incisions or injury injected the dermal filler Restylane into the buttocks area of nearly two dozen 80-year-olds. They then conducted biopsies after one, two, four and 12 weeks.
"When we injected the filler and increased the mechanical pressure around the cells, the cells responded robustly," says Gary Fisher, Ph. D, the Harry Helfman Professor of Molecular Dermatology at the University of Michigan and senior author of the study. "They made new collagen and several features of the skin improved in the direction of looking younger and behaving younger."
Medicis, the manufacturer of Restylane, a popular product used to soften wrinkles on the face, donated the filler but was otherwise not involved in the study.
Skin cells are surrounded by connective tissue which is largely made of collagen, Fisher explains. When this connective tissue or extracellulal matrix (ECM) ages, it fragments, causing the skin cells to deteriorate further. When the filler was injected into the old folks’ buns, it bolstered the ECM and caused the skin cells to produce more collagen. The layer of skin also grew thicker and produced more blood vessels.
"Essentially, we're fooling them," says Fisher. "Not by manipulating something inside the cell but by manipulating the external environment. The observed failure of the cells to function well may not reflect inherent changes in cells. It may reflect their response to the fact that their environment is becoming fragmented and falling apart."
Fisher likens aging skin cells and the material surrounding them to a person living in a collapsing house.
"It's like if you were in your home and your daily activities were to cook and clean and move around your house but then your house fell apart around you," he says. "Basically, you'd just sit in one spot. You couldn't cook, clean, or take a shower. Your behavior would look like you'd stopped to function but the fact is there's nothing wrong with you."
Skin cells surrounded by an aging matrix "give up," he says, much like the person in the collapsing house. Injecting filler into the area, however, doesn't just plump up the skin, but fools the cells into acting young again.
"They sense the increase in the mechanical pressure around them as a need to produce more collagen," he says.
If making the backside look younger -- and not the face -- seems like a waste, Fisher says the rear end is typically less damaged by the sun or other environmental factors.
"We did that because we wanted to separate the effects of environmental damage from the effects of chronological aging," says Fisher. "Most people cover their rear ends most of the time."
"We now know the cells -- even though they appear to be sleepy -- are just waiting for the right signal to stimulate them," says Fisher, adding that with further research, some kind of medicinal lotion might be developed for therapeutic purposes.
"It could go into the skin like a drug and activate some molecular biochemical pathway that would turn on the cells," he says.
Interestingly, this is not the first study to use dermal fillers on the buttocks area in order to test their effect on aging skin.
"Buttocks skin is turning out to be a really fertile area for research," says Dr. Hema Sundaram, founder and director of Sundaram Dermatology, Cosmetic & Laser Surgery and author of "Face Value: The Truth about Beauty-- and a Guilt-Free Guide to Finding It." "It's been used for a few years now. It's not exposed to the sun and patients are more willing to have biopsies from there because it doesn't show."
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The compounding pharmacy blamed for 620 infections and 39 deaths in an outbreak of fungal meningitis and other infections caused by contaminated drugs filed for bankruptcy Friday, and pledged to establish a fund to compensate victims.
The New England Compounding Center of Framingham, Mass., faces more than 400 lawsuits from patients who received epidural steroid injections later found to be tainted with fungus linked to serious and lethal infections, records showed.
The company filed for Chapter 11 bankruptcy protection in the Massachusetts district bankruptcy court.
In a statement issued late Friday, the company said the goal of the bankruptcy is to provide a "greater, quicker, fairer payout" to creditors than could be achieved through "piecemeal" litigation.
NECC also announced the appointment of Keith D. Lowey as the firm's independent director and chief restructuring officer. He will supervise the restructuring and be responsible for establishing NECC's effort to create a compensation fund. NECC's bankruptcy counsel, Daniel Cohn, said that claimants and their lawyers will be "actively involved" in the compensation process, according to the statement.
"Many families across the U.S. have been impacted by this great tragedy, and it is difficult to comprehend the sense of loss so many people have experienced," Lowey said in a statement. "Everyone associated with the New England Compounding Center shares that sense of loss."
Elizabeth A. Kaveny, a lawyer who represents five clients, all in Michigan, who said they were sickened by contaminated shots, says the company's action is no guarantee of justice for the alleged victims.
"NECC gets no bonus points for establishing a 'victims' compensation fund' after victimizing hundreds of patients in our country," she said in a statement to NBC News. "It is an obvious and necessary step of a bankruptcy proceeding and all victims need to be compensated. While NECC clearly should declare bankruptcy and never be permitted to reopen its doors, we have significant questions as to why this is a Chapter 11 bankruptcy, what funds are available for NECC's victims and how the victims' claims will be evaluated."
Problems with three lots of NECC steroids injected into some 14,000 people in 23 states were first detected in September. The company was shuttered in October after federal inspectors found widespread evidence of contamination throughout the pharmacy, some dating back to January.
The firm was licensed as a compounding pharmacy and was supposed to be mixing medications to order on prescription-by-prescription basis. However, investigations have shown the firm worked on a much larger scale and evaded several run-ins with the Food and Drug Administration and state regulators over the size of its operation and previous cases of contamination.
The illnesses and deaths -- which include not only fungal meningitis, but strokes, joint infections and spinal infections -- have prompted new demands to overhaul the way that compounding pharmacies are regulated in the U.S.
By Carey Gillam
A controversial genetically engineered salmon has moved a step closer to the consumer's dining table after the U.S. Food and Drug Administration said Friday the fish didn't appear likely to pose a threat to the environment or to humans who eat it.
AquAdvantage salmon eggs would produce fish with the potential to grow to market size in half the time of conventional salmon. If it gets a final go-ahead, it would be the first food from a transgenic animal - one whose genome has been altered - to be approved by the FDA.
The AquAdvantage Atlantic salmon egg was developed by AquaBounty Technology to speed up production to meet global seafood demand.
In a draft environmental assessment, the FDA affirmed earlier findings that the biotech salmon was not likely to be harmful. It said it would take comments from the public on its report for 60 days before making a final decision on approval.
"With respect to food safety, FDA has concluded that food from AquAdvantage salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption," the FDA assessment states.
AquaBounty officials said they were caught by surprise by the news that its product was a step closer to approval as years of controversy had followed the company's application for a go-ahead from the regulator. They said they did not know the timing or details of the process the FDA will follow following the 60-day comment period.
"We are encouraged that the environmental assessment is being released and hope the government continues the science-based regulatory process," said AquaBounty Chief Executive Ronald Stotish.
Critics say the new salmon is a "dangerous experiment" and have pressured the FDA to reject it. They say the FDA has relied on outdated science and substandard methods for assessing the new fish.
"We are deeply concerned that the potential of these fish to cause allergic reactions has not been adequately researched," said Michael Hansen, a scientist at the Consumers Union. "FDA has allowed this fish to move forward based on tests of allergenicity of only six engineered fish, tests that actually did show an increase in allergy-causing potential."
There were also concerns the FDA would not require the genetically modified salmon to be labeled as such, and some critics said they may file a lawsuit to prevent what they fear could be the imminent approval of the engineered fish.
"Congress can still keep FDA from unleashing this dangerous experiment," said Wenonah Hauter, executive director of Food & Water Watch, a consumer advocacy group. "Although this latest FDA decision is a blow to consumer confidence, we encourage everyone to contact their members of Congress and demand this reckless decision be overturned."
The Center for Food Safety, another non-profit consumer protection group, was highly critical of the FDA report, and officials said they might sue the regulator over the issue.
"It is extremely disappointing that the Obama Administration continues to push approval of this dangerous and unnecessary product," said Andrew Kimbrell, executive director of the Center for Food Safety. "The GE salmon has no socially redeeming value. It's bad for the consumer, bad for the salmon industry and bad for the environment."
FDA spokeswoman Morgan Liscinsky said no final decisions have been made on labeling or on the application for approval.
By Jeri Clausing
The Department of Justice is seeking a permanent injunction against the nation's largest organic peanut butter plant, an eastern New Mexico facility that has been linked to a salmonella outbreak that has sickened 42 people in 20 states this fall.
The request filed Thursday in federal court in Albuquerque seeks to prohibit Sunland Inc. in Portales from receiving, processing, manufacturing or selling any nut products until the Food and Drug Administration is satisfied its operations are safe.
It wasn't immediately clear what prompted federal prosecutors to get involved in the case against Sunland, whose registration to operate was revoked by the FDA last month because of repeated safety violations.
That order came as the company had planned to reopen some its operations after voluntarily recalling hundreds of products and closing its processing and peanut butter plants in late September and early October.
Last week, a Sunland spokeswoman said the company was hoping to get permission from the FDA to reopen its peanut processing plant so it could begin work on the millions of pounds of Valencia peanuts piled up in barns after a bumper harvest this fall.
Plant officials didn't immediately return phone calls Friday seeking comment.
The FDA's revocation of the company's operation certification marked the first time the FDA used the authority granted under a 2011 food safety law that allows the agency to halt food operations without a court hearing.
The action was denounced as unfair and unnecessarily heavy-handed by many in the conservative farm town of Portales, where Sunland is the largest private employer. At the end of November, the plant had laid off about 30 percent of its 150 workers.
The FDA said inspectors found samples of salmonella in 28 different locations in the plant, in 13 nut butter samples and in one sample of raw peanuts. Inspectors found improper handling of the products, unclean equipment and uncovered trailers of peanuts outside the facility that were exposed to rain and birds. Inspectors also said employees lacked access to hand-washing sinks, and dirty hands had direct contact with ready-to-package peanuts.
The FDA said it inspected the plant at least four times over the past five years, each time finding violations. Michael Taylor, the FDA's deputy commissioner for foods, said the agency's inspections after the outbreak found even worse problems than what had been seen there before.
Plant officials have said they were never notified of past violations.
The salmonella outbreak was traced to Trader Joe's Valencia peanut butter produced at the plant. According to the Centers for Disease Control and Prevention, 42 people were sickened, mostly children. Sunland is the nation's largest organic peanut butter plant. It produces organic, natural and traditional products for a number of national grocery and retail chains using mostly Valencia peanuts.
Valencias are a variety of peanuts that come almost exclusively from eastern New Mexico. Because of their sweet flavor, they are favored for organic and natural peanut butter products because they require few additives.