Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

Antidepressants don’t raise stillbirth risk: study






NEW YORK (Reuters Health) – Taking common antidepressants during pregnancy doesn’t increase a woman’s risk of having a stillbirth, according to a new study of over one million Nordic women.


The drugs, known as selective serotonin reuptake inhibitors, or SSRIs, include fluoxetine (marketed as Prozac) and citalopram (Celexa).






Earlier studies have tied SSRIs to a slightly higher rate of some kinds of birth defects and newborn lung problems. But whether the drugs also raise a woman’s chance of stillbirth – when the fetus dies in the uterus after at least 20 weeks of pregnancy – has been unclear.


“Studies previously have not really been large enough to answer this question,” said Dr. Olof Stephansson, the lead author of the new report from the Karolinska Institutet in Stockholm.


“From our study, we don’t find any reason to stop taking your medication, because untreated depression may be harmful for the pregnancy and the baby,” he told Reuters Health.


Stephansson and his colleagues consulted prescription drug registries and birth records from Denmark, Finland, Iceland, Norway and Sweden, including more than 1.6 million births between 1996 and 2007. Just over 29,000 of the mothers, or close to two percent, had filled a prescription for an antidepressant during their pregnancy.


Overall, between three and four of every 1,000 births was a stillbirth, the research team reported this week in the Journal of the American Medical Association.


In addition, about two of every 1,000 babies died within four weeks of being born and one in 1,000 died between one and 12 months of age.


Antidepressant use at any time during pregnancy was initially tied to a slightly higher risk of stillbirth. But when Stephansson and his colleagues took into account women’s general health, age and whether they smoked, any effect of the drugs disappeared.


Moms-to-be who were on SSRIs tended to be older and were more likely to smoke and have diabetes and high blood pressure than those who weren’t taking antidepressants, Stephansson said.


There was still a slightly higher chance of stillbirth among women who took the drugs very early in their pregnancies – the time when a fetus is thought to be most vulnerable to its mother’s medications and environmental exposures. But because less than 100 women fit into that category and had a stillbirth the finding “should be interpreted with caution,” the researchers said.


Blaming pregnancy complications on any specific drug is always a challenge, according to one researcher not involved in the new study.


“It’s difficult and under most circumstances impossible to separate the effects of SSRIs and depression itself or the lifestyle associated with depression,” said Dr. Richard Shelton, a psychiatrist who has studied antidepressant use in pregnancy at the University of Alabama at Birmingham.


For example, even when women’s general health and behavior are accounted for, they might not mention drinking and illegal drug use – which can be tied to both depression and pregnancy complications.


But so far, the evidence suggests the effects of antidepressant use during pregnancy are “pretty neutral,” Shelton told Reuters Health.


IF YOU NEED THEM, TAKE THEM: RESEARCHERS


Women who are taking antidepressants and planning a pregnancy should talk with both their obstetrician and psychiatrist to figure out what will be safest for them and their baby, Stephansson said.


But the bottom line, he added, is that “you should stick to the lowest dose possible and not stop with the medication if you need it.”


“The general recommendation is if a woman can be off an antidepressant medication during pregnancy, that’s probably a good idea. I think that’s probably a good idea for any kind of medication,” said Shelton, because all drugs may have small, unknown risks.


“But if a woman is depressed enough to warrant treatment, then treatment is probably reasonable,” he added. That can mean antidepressants or other options such as talk therapy.


Shelton said women should also seek treatment for other health and lifestyle issues tied to depression, such as being overweight and smoking, preferably before getting pregnant.


SOURCE: http://bit.ly/VvAQrl Journal of the American Medical Association, online January 1, 2013.


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Biden will discuss “fiscal cliff” deal with House Democrats






WASHINGTON (Reuters) – Vice President Joe Biden will meet with fellow Democrats in the House of Representatives on Tuesday to discuss the “fiscal cliff” deal that he forged with Senate Republican leader Mitch McConnell, a Democratic aide said.


The meeting is to be held at the Capitol at 12:15 p.m. ET (1715 GMT).






Biden needed to help sell Senate Democrats on the deal before they joined Republicans at about 2 a.m. ET (0700 GMT) in approving the measure. The Republican-led House may vote on the bill as early as later in the day.


(Reporting By Thomas Ferraro; Editing by Vicki Allen)


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Palestinians say 9 dead from swine flu outbreak






RAMALLAH, West Bank (AP) — A Palestinian health official says an outbreak swine flu has killed nine people.


Deputy Health Minister Asad Ramlawi also said Monday more than 225 people have been infected by the H1N1 influenza strain, known as swine flu. He said more than 25,000 vaccinations have been administered this year to prevent it. The West Bank has 2.5 million residents.






The West Bank has been struck by swine flu before. Dozens died in the Palestinian territories during the 2009 worldwide pandemic.


The first outbreak was discovered in Mexico in March 2009. Thousands died around the world, causing a global panic. The World Health Organization declared swine flu the first global flu pandemic in 40 years.


H1N1 is now considered a seasonal flu and included in the standard annual flu vaccine.


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Italian Nobel scientist Montalcini dies at 103






ROME (Reuters) – Rita Levi Montalcini, joint winner of the Nobel Prize for Medicine and an Italian Senator for Life, died on Sunday at the age of 103, her family said.


The first Nobel laureate to reach 100 years of age, she won the prize in 1986 with American Stanley Cohen for their discovery of nerve growth factor (NGF), a protein that makes developing cells grow by stimulating surrounding nerve tissue.






Her research helped in the treatment of spinal cord injuries and has increased understanding of cardiovascular diseases, Alzheimer’s and conditions such as dementia and autism.


One of twins born to a Jewish family in Turin in 1909, Montalcini was the oldest living recipient of the prize.


During World War Two, the Allies’ bombing of Turin forced her to flee to the countryside where she established a mini-laboratory. She fled to Florence after the German invasion of Italy and lived in hiding there for a while, later working as a doctor in a refugee camp.


After the war she moved to St. Louis in the United States to work at Washington University, where she went on to make her groundbreaking NGF discoveries.


She also set up a research unit in Rome and in 1975 became the first woman to be made a full member of the Vatican’s Pontifical Academy of Sciences in 1975. She won several other awards for her contributions to medical and scientific research.


Her face was instantly recognizable in Italy and she was well known as a dignified and respected intellectual, a counterbalance to the image of women succeeding through their looks and sexuality, exacerbated during the scandal-plagued era of former prime minister Silvio Berlusconi.


Two days after her birthday in April this year she posted a note on Facebook saying it was important never to give up on life or fall into mediocrity and passive resignation.


“I’ve lost a bit of sight, and a lot of hearing. At conferences I don’t see the projections and I don’t feel good. But I think more now than I did when I was 20. The body does what it wants. I am not the body, I am the mind,” she said.


Italian Prime Minister Mario Monti said in a statement that Montalcini’s Nobel prize had been an honor for Italy, and praised her efforts to encourage young people, especially women, to play a central role in scientific research.


(Editing by Louise Ireland)


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Brazil president, cancer survivor, pronounced healthy






BRASILIA (Reuters) – Brazilian President Dilma Rousseff, who survived lymphoma cancer in 2009, was pronounced healthy by doctors after a routine exam on Friday.


Rousseff’s health was “within normal levels,” according to a statement released by her office following the check-up at the Sirio-Libanes Hospital in Sao Paulo, one of South America‘s leading cancer treatment centers.






Rousseff underwent chemotherapy in 2009 and briefly wore a wig, but the cancer went into remission and she appeared to be in good health by the time she staged her winning campaign for the presidency in 2010.


Concerns over her health have faded since then, although a bout with pneumonia and a lengthy recovery in 2011 have kept the issue on some investors’ radar screens.


(Reporting by Ana Flor, Writing by Brian Winter; Editing by Doina Chiacu)


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Cancer Sucks to donate $150,000 to cancer research







It will be the largest single donation given by Cancer Sucks, stated the organization’s executive director, Rick Horton, in a recent release.






Cancer Sucks, which will be the recipient of funds raised from the upcoming The Party! New Year’s Eve event in Tulsa’s Blue Dome District, will be donating proceeds from the Shiprocked Music Cruise charity auction, as well as the John F. Henry PanSlam Golf Classic for pancreatic cancer research.


Cancer Sucks will donate $ 70,000 to Gateway for Cancer Research, $ 40,000 to Oklahoma State University Center for Health Sciences and $ 40,000 to the University of Oklahoma Health Sciences Center.


Cancer Sucks was established in 1998 by the family of Donna Holland White, who died in 1996. The organization, which is run by volunteers who have been touched by cancer, focuses on raising as much money for cancer research as possible. Corporate partnerships fund overhead expenses, allowing Cancer Sucks to donate all proceeds from events to cancer research.


For more, tulsaworld.com/cancersucks


deb87  basic Cancer Sucks to donate $150,000 to cancer research


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Study finds spiritual care still rare at end of life






NEW YORK (Reuters Health) – Physicians and nurses at four Boston medical centers cited a lack of training to explain why they rarely provide spiritual care for terminally ill cancer patients – although most considered it an important part of treatment at the end of life.


“I was quite surprised that it was really just lack of training that dominated the reasons why,” senior author Dr. Tracy Balboni, a radiation oncologist at the Dana-Farber Cancer Institute in Boston, told Reuters Health.






Current U.S. palliative care guidelines encourage medical practitioners to pay close attention to religious and spiritual needs that may arise during a patient’s end-of-life care.


However, the 204 physicians who participated in the study reported providing spiritual care to just 24 percent of their patients. Among 118 nurses, the figure was 31 percent.


The 69 patients with advanced cancers who took the survey reported even lower rates, saying 14 percent of nurses and six percent of physicians had provided them some sort of spiritual care.


Past research has shown that spiritual care for seriously ill patients improves their quality of life, increases their overall satisfaction with hospital care and decreases aggressive medical treatment, which may in turn result in lower overall health spending.


“There was a time when nurses and physicians may have said, ‘That’s not my job,’ but I think the tides are changing,” said palliative care researcher Betty Ferrell of City of Hope, a cancer research and treatment hospital in Duarte, California.


“I think we are realizing we can no longer ignore this aspect of care,” said Ferrell, a professor of nursing who was not involved in the new study.


Yet the reasons why spiritual care is rarely incorporated into patient treatment and dialogue have been poorly understood.


To gain more insight, Balboni and her colleagues designed a survey – the first of its kind, to their knowledge – to compare attitudes toward spiritual care across randomly chosen patients, nurses and doctors in oncology departments at four hospitals.


The questions were geared toward identifying barriers preventing healthcare professionals from delivering spiritual care, beginning with whether anyone felt it was inappropriate for them to be doing so.


The participants’ answers indicated that, on the contrary, a majority of providers and patients supported the appropriateness of eight specific examples of spiritual care, such as a doctor or nurse praying with a patient at his or her request or referring the patient to a hospital chaplain.


Next, the researchers asked participants to rate previous spiritual care experiences. Again, most ranked these as having a positive impact on care. A fourth possibility offered to nurses and doctors was lack of time.


“Indeed we found that on average 73 percent reported time to be a significant barrier to spiritual care provision to patients,” Balboni told Reuters Health in an email.


But those who noted insufficient time as a problem provided spiritual care just as often as those who reported having enough time. That suggested time was not an issue after all, she added.


In fact, a lack of training stood out as the biggest barrier to providing spiritual care in this small study.


Only 13 percent of doctors and nurses reported having ever received spiritual care training.


But those who had training were seven to 11 times more likely to provide spiritual care to their patients than those who hadn’t been trained.


A lack of “models” for training healthcare professionals to tend to patients’ spiritual needs seems to be the underlying problem, Balboni told Reuters Health.


“There are some basic models, but a rigorously developed spiritual care training model has not been established,” she said.


Ferrell, who leads End-of-Life Nursing Education Consortium workshops, said such small-scale organized training opportunities are drops in the bucket of a huge unmet training need.


“We can’t practice what we don’t know,” she said. “Physicians and nurses have never been taught to access and respond to spiritual need.”


In addition to training, the field of spiritual care needs a clear definition, said Dr. Christina Puchalski, director of the George Washington Institute for Spirituality and Health in Washington, D.C.


“There is quite a bit of controversy about asking only about religion,” Puchalski said. “But previous studies have shown that it’s not a patient’s particular religious denomination that matters, but what gives meaning and purpose in peoples’ lives -things such as family, arts, work, nature, yoga and other values.”


Puchalski, who invented a basic spiritual assessment questionnaire that is in wide use, added that the study could have benefitted by asking patients if nurses and doctors acted compassionately toward them, which is another example of spiritual care.


In a country full of diverse cultures, spiritual care may be intimidating to medical workers, but training can help with that, Ferrell said.


“For example, if we have a patient who says, ‘I’m very devout in my faith and I never make decisions without consulting my rabbi,’ then we immediately take that into account – perhaps by giving the patient extra time between procedures,” she noted.


“Patients are telling us spiritual care has to be done with greater intention,” Ferrell said.


SOURCE: http://bit.ly/Zm7Fey Journal of Clinical Oncology, online December 17, 2012


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‘Bumping’ Your Way to Safer Sex With a Smartphone App






Reported by Dr. Lauren Browne:


Let’s face it.  Teens have sex.  Parents may choose to ignore it, and teens may choose to deny it, but almost 50 percent of American high school students are having sex, according to the U.S. Centers for Disease Control. And each year, millions of those sexually active teens contract sexually transmitted diseases such as chlamydia, gonorrhea, syphilis, herpes and HIV.






Now one doctor hopes to curb the spread of STDs in this tech savvy group with a smartphone app that lets users “bump” their STD status.


It’s called ‘safe bumping,’” said Dr. Michael Nusbaum, the New Jersey developer of MedXSafe, a feature of the new app called MedXCom.  “If you happen to be out at a bar or a fraternity house or wherever, and you meet someone, you can then bump phones and exchange contact information and STD status.”


The app’s special feature, according to Nussbaum, encourages dating singles to go to the doctor for regular STD checks.  Those who screen negative can ask their doctors to document their STD-free status on the app, allowing users to share the information with whomever they choose.


An alarming 19 million new sexually transmitted infections occur each year, and rates of chlamydia and gonorrhea are on the rise, according to a new report released this month by the CDC.  More than 1.4 million chlamydia infections were reported in 2011, up 8 percent from the previous year.  Cases of gonorrhea were up by 4 percent, marking the second consecutive year of increases.


Nearly half of all infections occur in young people, between the ages of 15 to 24, a group that can be particularly devastated by the associated health effects.


“[Some] undetected and untreated STDs can increase a person’s risk for HIV and cause other serious health consequences, such as infertility,” said Mary McFarlane, an acting chief in the Division of STD Prevention at the CDC.  Harnessing modern social networking technology to prevent these infections may appeal to a younger tech-savvy generation.


MedXSafe is just one of several Internet-based programs devoted to easing confidential STD-status sharing between sexual partners.  Services like Qpid.me, whose slogan is Spread the Love, Nothing Else and U Should Know, designed by a former college student and his girlfriend, also allow their users to check on a partner’s STD status.


But could these services offer a false sense of security to teens who believe that, with a simple phone bump, they have the green light to have unprotected sex?


“It can take months for HIV to show up on a test,” said Renee Williams, executive director of SAFE, a nonprofit organization dedicated to abstinence education.  “So you can test negative today, go out on Friday night and have sex, and then get retested later and find out that you had HIV all along.”


The app does nothing to prevent unplanned pregnancy, and may even encourage high-risk behaviors that young people might otherwise not have been tempted to try, said Williams.


Nor is the app likely to be completely reliable, said Dr. J. Joseph Speidel, director of communication at the Bixby Center for Global Reproductive Health.


“Does it come with a condom?” asked Dr. Richard Besser, ABC’s chief health and medical editor, who’s also a pediatrician and former acting director at the CDC.


But the app’s creator said it does promote regular STD testing and encourages potential partners to openly discuss safe sex practices.


“We’re recognizing that this behavior is going to take place no matter what we do or what we say,” said Nusbaum.  “I have friends that are nuns and I’ve run this by them, and they also agree that it’s promoting safer behaviors.”


Although each program promises to keep health information strictly confidential, none are immune from cyber attacks.


But such attacks would not expose any users who have an STD, according to Nusbaum.  MedXSafe does not allow doctors to upload information about any tests that come back positive, including HIV.  A user with an infection is simply treated for the STD and then retested.  And that user is only confirmed STD-free via the app once subsequent test results come back negative.


Still, it is too early to tell whether these services will become popular with teens.  Lingering social stigma surrounding STDs might make potential partners reluctant to mention such an app when out at a party.


“It’s a big personal step to bring up using such an app,” said Noah Bloom, creator of a smartphone app called Jiber, which uses the same “bump” technology to electronically connect new friends.  “Who really wants anything in the way of getting lucky?”


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12 Weeks is a Long Time to Wait for Breast Cancer Chemotherapy






FIRST PERSON | How long a wait is too long when it comes to treatment of breast cancer? A report published in the Dec. 19 issue of JNCI, Journal of the National Cancer Institute, states that after examining records from 6,622 women, the average time for a woman to wait for adjuvant chemotherapy (chemo given after surgery) for breast cancer is 12 weeks. After my surgery, I waited four weeks before chemotherapy began.


Reconstruction delays






A main cause for delays in starting chemotherapy after surgery was immediate reconstruction. Flap surgeries allow for immediate breast reconstruction. This type of surgery requires a long recuperation period. Chemotherapy impedes healing. All incisions must be healed and all drains removed before chemotherapy can start.


I chose breast implants for reconstruction. This process was partially started during my mastectomy — consider it partially immediate reconstruction. A tissue expander was put in after they removed my breast. Recovery time is significantly less than with flap surgery. I still had some stitches in when chemo started.


Testing and imaging delays


Testing such as 21-gene reverse-transcription polymerase chain reaction assay testing and MRIs increased the time frame from lumpectomy or mastectomy to the start of chemotherapy. Some doctors use post-surgical MRIs to determine if clear margins were reached. If they are unhappy with the results of the MRI, a second surgery may be required, thus increasing the time before chemo can start.


My oncologist did not feel that any further testing other than a MUGA scan was necessary following my mastectomy. The MUGA scan was performed in order to check heart function before starting on treatment with a monoclonal antibody. Even though I had to go through this imaging, it did not delay the start of chemotherapy.


Other delays


One of the biggest causes of delays in starting chemotherapy treatment in minority women was access to health insurance. Black women who received Medicaid had the longest wait between surgery and the start of chemotherapy when compared to white women with private insurance. This is something that needs to change. When dealing with breast cancer, the faster and more aggressively it is treated, the better the prognosis for survival. There is no reason a woman should have to wait for treatment just because the government is paying for the chemotherapy.


Twelve weeks is too long to wait to start chemotherapy after surgery. Imaging should not have an impact on how long a person waits for chemo. Waiting too long, especially with aggressive forms of breast cancer could be the difference between life and death. I had imaging and started chemo just four weeks after my mastectomy. My outcome might have been very different had I been forced to wait an additional eight weeks before I started chemotherapy.


Lynda Altman was diagnosed with breast cancer in November 2011. She writes a series for Yahoo! Shine called “My battle with breast cancer.”


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Former President George H.W. Bush remains hospitalized






(Reuters) – Former President George H.W. Bush, who has been hospitalized for a month undergoing treatment for bronchitis, may not be released from a Houston hospital in time to celebrate Christmas at home as doctors had hoped.


Bush, 88, remained in stable condition and doctors were optimistic he would make a full recovery, George Kovacik, a spokesman at Methodist Hospital, said in an emailed statement on Sunday.






But doctors were being “extra cautious” with his care and no discharge date had been set, the statement said. Earlier this month, Kovacik said doctors expected Bush would be able to spend Christmas at home with his family.


“His doctors feel he should build up his energy before going home,” the statement said.


Bush, the 41st president and a Republican, took office in 1989 and served one term in the White House. The father of former President George W. Bush, he also is a former congressman, U.N. ambassador, CIA director and vice president for two terms under Ronald Reagan.


(Reporting by Kevin Gray; Editing by Daniel Trotta and Vicki Allen)


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Bieber’s Hamster Giveaway Causes Furry Furor







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Justin Bieber bonds with his former pet, Pac-the-hamster. Image credit: Twitter @PacBieber.



Here’s a story that will give you paws. Or at least it has paws.






According to TMZ, Justin Bieber gave an unsuspecting fan an early Christmas present by unloading his pet hamster, named PAC, on her during a recent concert.


“That’s all you,” Bieber can be heard shouting to the girl over the screams of the crowd as the incident was captured on grainy video. “You gotta take care of PAC.”


The girl, identified as Victoria Blair, age 18, screamed back, “I will take care of him!”


The California Hamster Association is not amused. They simply cannot belieb the pop star acted so irresponsibly.


First of all, yes. There really is a California Hamster Association (CHA). And second, as David Imber, an adviser and spokesman for the organization pointed out – what Bieber did was not cool.


“No doubt Justin Bieber meant well in delighting his adoring fan with the gift of his hamster, but without realizing it he was practicing a form of animal cruelty,” Imber said.


“We have subsequently read that the recipient is attempting to be responsible about caring for the animal, but absent any other indication, in general it is extremely likely that this hamster would have been harmed,” Imber continued. “No pet, large or small, should ever be ‘gifted’ to an unknowing recipient.”


Beiber could not immediately be reached for comment by ABC News but Blair told ABC News that PAC is doing fine.


If you are considering giving the gift of a hamster this year, the CHA urges using some common sense.


This means never surprising someone with any sort of creature, let alone something as sensitive and fragile as a cute and furry little hamster. Without discussing it with them first, you don’t know if someone has the means or desire to provide proper care for the animal (as with any animal), including suitable housing, plenty of food and water, and one of those squeaky exercise wheels. And definitely, under no circumstances should you hand over a pet to the recipient at a concert.


Imber worried that most people don’t realize hamsters actually don’t make great pets for little kids even though they are inexpensive and reproduce in great numbers.


“They do not typically sit calmly in one’s lap, but roam incessantly — the reason we give them wheels — and they have a very short life span of fewer than 1,000 days,” he said.


If you do decide to go forward with a pet present, remind the new owner that they can leave it in the care of a shelter or animal rescue center should they no longer wish to keep it — again, keeping in mind that any handoff should not occur in the midst of a screaming mob of adolescent girls.


But anyway, three holiday cheers for PAC’s new situation. Our little ham-star doesn’t appear doomed to die a horrible death as the CHA initially feared. In fact, he seems to be thriving like the tiny rodent royalty he is, even tossing out the occasional tweet to his nearly 46,000 followers.


“Yes, it’s true. @victoriablair21 is ‘my’ new owner, she takes care of me so don’t worry,” said one of his tweets that posted a few days after he was handed over to Blair.


It was hashtagged, #happyhamster.


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FDA approves Roche’s Tamiflu for infants with new flu symptoms






(Reuters) – The U.S. Food and Drug Administration on Friday expanded the use of Tamiflu, the flu drug from Roche, to children as young as two weeks old who have shown flu symptoms for no more than two days.


The FDA said the drug cannot be used to prevent flu infection in this age group. The drug is currently approved as both a flu treatment and preventative flu drug for children ages 1 and older, and adults. It aims to help lessen the length and severity of the flu.






Tamiflu was approved in 1999 and is distributed in the United States by Genentech, part of Roche. It was co-developed by Gilead Sciences. Its most common side effects include vomiting and diarrhea.


The FDA said its expanded use is based on extrapolating data from previous study results in adults and older children, and supporting studies by the U.S. National Institutes of Health and Roche.


Tamiflu, which had peak sales of $ 3 billion in 2009 because of the H1N1 swine flu epidemic, is approved by regulators worldwide but some researchers claim there is little evidence it works and have asked Roche to hand over data so they can study its effectiveness.


(Reporting By Caroline Humer; Editing by Grant McCool)


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AP IMPACT: Steroids loom in major-college football






WASHINGTON (AP) — With steroids easy to buy, testing weak and punishments inconsistent, college football players are packing on significant weight — 30 pounds or more in a single year, sometimes — without drawing much attention from their schools or the NCAA in a sport that earns tens of billions of dollars for teams.


Rules vary so widely that, on any given game day, a team with a strict no-steroid policy can face a team whose players have repeatedly tested positive.






An investigation by The Associated Press — based on dozens of interviews with players, testers, dealers and experts and an analysis of weight records for more than 61,000 players — revealed that while those running the multibillion-dollar sport believe the problem is under control, that is hardly the case.


___


EDITOR’S NOTE — Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the first of a two-part series.


___


The sport’s near-zero rate of positive steroids tests isn’t an accurate gauge among college athletes. Random tests provide weak deterrence and, by design, fail to catch every player using steroids. Colleges also are reluctant to spend money on expensive steroid testing when cheaper ones for drugs like marijuana allow them to say they’re doing everything they can to keep drugs out of football.


“It’s nothing like what’s going on in reality,” said Don Catlin, an anti-doping pioneer who spent years conducting the NCAA‘s laboratory tests at UCLA. He became so frustrated with the college system that it drove him in part to leave the testing industry to focus on anti-doping research.


Catlin said the collegiate system, in which players often are notified days before a test and many schools don’t even test for steroids, is designed to not catch dopers. That artificially reduces the numbers of positive tests and keeps schools safe from embarrassing drug scandals.


While other major sports have been beset by revelations of steroid use, college football has operated with barely a whiff of scandal. Between 1996 and 2010 — the era of Barry Bonds, Mark McGwire, Marion Jones and Lance Armstrong — the failure rate for NCAA steroid tests fell even closer to zero from an already low rate of less than 1 percent.


The AP’s investigation, drawing upon more than a decade of official rosters from all 120 Football Bowl Subdivision teams, found thousands of players quickly putting on significant weight, even more than their fellow players. The information compiled by the AP included players who appeared for multiple years on the same teams, making it the most comprehensive data available.


For decades, scientific studies have shown that anabolic steroid use leads to an increase in body weight. Weight gain alone doesn’t prove steroid use, but very rapid weight gain is one factor that would be deemed suspicious, said Kathy Turpin, senior director of sport drug testing for the National Center for Drug Free Sport, which conducts tests for the NCAA and more than 300 schools.


Yet the NCAA has never studied weight gain or considered it in regard to its steroid testing policies, said Mary Wilfert, the NCAA’s associate director of health and safety. She would not speculate on the cause of such rapid weight gain.


The NCAA attributes the decline in positive tests to its year-round drug testing program, combined with anti-drug education and testing conducted by schools.


“The effort has been increasing, and we believe it has driven down use,” Wilfert said.


Big gains, data show


The AP’s analysis found that, regardless of school, conference and won-loss record, many players gained weight at exceptional rates compared with their fellow athletes and while accounting for their heights. The documented weight gains could not be explained by the amount of money schools spent on weight rooms, trainers and other football expenses.


Adding more than 20 or 25 pounds of lean muscle in a year is nearly impossible through diet and exercise alone, said Dan Benardot, director of the Laboratory for Elite Athlete Performance at Georgia State University.


The AP’s analysis corrected for the fact that players in different positions have different body types, so speedy wide receivers weren’t compared to bulkier offensive tackles. It could not assess each player’s physical makeup, such as how much weight gain was muscle versus fat, one indicator of steroid use. In the most extreme case in the AP analysis, the probability that a player put on so much weight compared with other players was so rare that the odds statistically were roughly the same as an NFL quarterback throwing 12 passing touchdowns or an NFL running back rushing for 600 yards in one game.


In nearly all the rarest cases of weight gain in the AP study, players were offensive or defensive linemen, hulking giants who tower above 6-foot-3 and weigh 300 pounds or more. Four of those players interviewed by the AP said that they never used steroids and gained weight through dramatic increases in eating, up to six meals a day. Two said they were aware of other players using steroids.


“I just ate. I ate 5-6 times a day,” said Clint Oldenburg, who played for Colorado State starting in 2002 and for five years in the NFL. Oldenburg’s weight increased over four years from 212 to 290, including a one-year gain of 53 pounds, which he attributed to diet and two hours of weight lifting daily. “It wasn’t as difficult as you think. I just ate anything.”


Oldenburg told the AP he was surprised at the scope of steroid use in college football, even in Colorado State’s locker room. “College performance enhancers were more prevalent than I thought,” he said. “There were a lot of guys even on my team that were using.” He declined to identify any of them.


The AP found more than 4,700 players — or about 7 percent of all players — who gained more than 20 pounds overall in a single year. It was common for the athletes to gain 10, 15 and up to 20 pounds in their first year under a rigorous regimen of weightlifting and diet. Others gained 25, 35 and 40 pounds in a season. In roughly 100 cases, players packed on as much 80 pounds in a single year.


In at least 11 instances, players that AP identified as packing on significant weight in college went on to fail NFL drug tests. But pro football’s confidentiality rules make it impossible to know for certain which drugs were used and how many others failed tests that never became public.


What is bubbling under the surface in college football, which helps elite athletes gain unusual amounts of weight? Without access to detailed information about each player’s body composition, drug testing and workout regimen, which schools do not release, it’s impossible to say with certainty what’s behind the trend. But Catlin has little doubt: It is steroids.


“It’s not brain surgery to figure out what’s going on,” he said. “To me, it’s very clear.”


Football’s most infamous steroid user was Lyle Alzado, who became a star NFL defensive end in the 1970s and ’80s before he admitted to juicing his entire career. He started in college, where the 190-pound freshman gained 40 pounds in one year. It was a 21 percent jump in body mass, a tremendous gain that far exceeded what researchers have seen in controlled, short-term studies of steroid use by athletes. Alzado died of brain cancer in 1992.


The AP found more than 130 big-time college football players who showed comparable one-year gains in the past decade. Students posted such extraordinary weight gains across the country, in every conference, in nearly every school. Many of them eclipsed Alzado and gained 25, 35, even 40 percent of their body mass.


Even though testers consider rapid weight gain suspicious, in practice it doesn’t result in testing. Ben Lamaak, who arrived at Iowa State in 2006, said he weighed 225 pounds in high school and 262 pounds in the summer of his freshman year on the Cyclones football team. A year later, official rosters showed the former basketball player from Cedar Rapids weighed 306, a gain of 81 pounds since high school. He graduated as a 320-pound offensive lineman and said he did it all naturally.


“I was just a young kid at that time, and I was still growing into my body,” he said. “It really wasn’t that hard for me to gain the weight. I had fun doing it. I love to eat. It wasn’t a problem.”


In addition to random drug testing, Iowa State is one of many schools that have “reasonable suspicion” testing. That means players can be tested when their behavior or physical symptoms suggest drug use.


Despite gaining 81 pounds in a year, Lamaak said he was never singled out for testing.


The associate athletics director for athletic training at Iowa State, Mark Coberley, said coaches and trainers use body composition, strength data and other factors to spot suspected cheaters. Lamaak, he said, was not suspicious because he gained a lot of “non-lean” weight.


“There are a lot of things that go into trying to identify whether guys are using performance-enhancing drugs,” Coberley said. “If anybody had the answer, they’d be spotting people that do it. We keep our radar up and watch for things that are suspicious and try to protect the kids from making stupid decisions.”


There’s no evidence that Lamaak’s weight gain was anything but natural. Gaining fat is much easier than gaining muscle. But colleges don’t routinely release information on how much of the weight their players gain is muscle, as opposed to fat. Without knowing more, said Benardot, the expert at Georgia State, it’s impossible to say whether large athletes were putting on suspicious amounts of muscle or simply obese, which is defined as a body mass index greater than 30.


Looking solely at the most significant weight gainers also ignores players like Bryan Maneafaiga.


In the summer of 2004, Maneafaiga was an undersized 180-pound running back trying to make the University of Hawaii football team. Twice — once in pre-season and once in the fall — he failed school drug tests, showing up positive for marijuana use. What surprised him was that the same tests turned up negative for steroids.


He’d started injecting stanozolol, a steroid, in the summer to help bulk up to a roster weight of 200 pounds. Once on the team, where he saw only limited playing time, he’d occasionally inject the milky liquid into his buttocks the day before games.


“Food and good training will only get you so far,” he told the AP recently.


Maneafaiga’s coach, June Jones, meanwhile, said none of his players had tested positive for doping since he took over the team in 1999. He also said publicly that steroids had been eliminated in college football: “I would say 100 percent,” he told The Honolulu Advertiser in 2006.


Jones said it was news to him that one of his players had used steroids. Jones, who now coaches at Southern Methodist University, said many of his former players put on bulk working hard in the weight room. For instance, adding 70 pounds over a three- to four-year period isn’t unusual, he said.


Jones said a big jump in muscle year-over-year — say 40 pounds — would be a “red light that something is not right.”


Jones, a former NFL head coach, said he is unaware of any steroid use at SMU and believes the NCAA is doing a good job testing players. “I just think because the way the NCAA regulates it now that it’s very hard to get around those tests,” he said.


The cost of testing


While the use of drugs in professional sports is a question of fairness, use among college athletes is also important as a public policy issue. That’s because most top-tier football teams are from public schools that benefit from millions of dollars each year in taxpayer subsidies. Their athletes are essentially wards of the state. Coaches and trainers — the ones who tell players how to behave, how to exercise and what to eat — are government employees.


Then there are the health risks, which include heart and liver problems and cancer.


On paper, college football has a strong drug policy. The NCAA conducts random, unannounced drug testing and the penalties for failure are severe. Players lose an entire year of eligibility after a first positive test. A second offense means permanent ineligibility from sports.


In practice, though, the NCAA’s roughly 11,000 annual tests amount to just a fraction of all athletes in Division I and II schools. Exactly how many tests are conducted each year on football players is unclear because the NCAA hasn’t published its data for two years. And when it did, it periodically changed the formats, making it impossible to compare one year of football to the next.


Even when players are tested by the NCAA, people involved in the process say it’s easy enough to anticipate the test and develop a doping routine that results in a clean test by the time it occurs. NCAA rules say players can be notified up to two days in advance of a test, which Catlin says is plenty of time to beat a test if players have designed the right doping regimen. By comparison, Olympic athletes are given no notice.


“Everybody knows when testing is coming. They all know. And they know how to beat the test,” Catlin said, adding, “Only the really dumb ones are getting caught.”


Players are far more likely to be tested for drugs by their schools than by the NCAA. But while many schools have policies that give them the right to test for steroids, they often opt not to. Schools are much more focused on street drugs like cocaine and marijuana. Depending on how many tests a school orders, each steroid test can cost $ 100 to $ 200, while a simple test for street drugs might cost as little as $ 25.


When schools call and ask about drug testing, the first question is usually, “How much will it cost,” Turpin said.


Most schools that use Drug Free Sport do not test for anabolic steroids, Turpin said. Some are worried about the cost. Others don’t think they have a problem. And others believe that since the NCAA tests for steroids their money is best spent testing for street drugs, she said.


Wilfert, the NCAA official, said the possibility of steroid testing is still a deterrent, even at schools where it isn’t conducted.


“Even though perhaps those institutional programs are not including steroids in all their tests, they could, and they do from time to time,” she said. “So, it is a kind of deterrence.”


For Catlin, one of the most frustrating things about running the UCLA testing lab was getting urine samples from schools around the country and only being asked to test for cocaine, marijuana and the like.


“Schools are very good at saying, ‘Man, we’re really strong on drug testing,’” he said. “And that’s all they really want to be able to say and to do and to promote.”


That helps explain how two school drug tests could miss Maneafaiga’s steroid use. It’s also possible that the random test came at an ideal time in Maneafaiga’s steroid cycle.


Enforcement varies


The top steroid investigator at the U.S. Drug Enforcement Administration, Joe Rannazzisi, said he doesn’t understand why schools don’t invest in the same kind of testing, with the same penalties, as the NFL. The NFL has a thorough testing program for most drugs, though the league has yet to resolve a long-simmering feud with its players union about how to test for human growth hormone.


“Is it expensive? Of course, but college football makes a lot of money,” he said. “Invest in the integrity of your program.”


For a school to test all 85 scholarship football players for steroids twice a season would cost up to $ 34,000, Catlin said, plus the cost of collecting and handling the urine samples. That’s about 0.2 percent of the average big-time school football budget of about $ 14 million. Testing all athletes in all sports would make the school’s costs higher.


When schools ask Drug Free Sport for advice on their drug policies, Turpin said she recommends an immediate suspension after the first positive drug test. Otherwise, she said, “student athletes will roll the dice.”


But drug use is a bigger deal at some schools than others.


At Notre Dame and Alabama, the teams that will soon compete for the national championship, players don’t automatically miss games for testing positive for steroids. At Alabama, coaches have wide discretion. Notre Dame’s student-athlete handbook says a player who fails a test can return to the field once the steroids are out of his system.


“If you’re a strength-and-conditioning coach, if you see your kids making gains that seem a little out of line, are you going to say, ‘I’m going to investigate further? I want to catch someone?’” said Anthony Roberts, an author of a book on steroids who says he has helped college football players design steroid regimens to beat drug tests.


There are schools with tough policies. The University of North Carolina kicks players off the team after a single positive test for steroids. Auburn’s student-athlete handbook calls for a half-season suspension for any athlete caught using performance-enhancing drugs.


Wilfert said it’s not up to the NCAA to determine whether that’s fair.


“Obviously if it was our testing program, we believe that everybody should be under the same protocol and the same sanction,” she said.


Fans typically have no idea that such discrepancies exist and players are left to suspect who might be cheating.


“You see a lot of guys and you know they’re possibly on something because they just don’t gain weight but get stronger real fast,” said Orrin Thompson, a former defensive lineman at Duke. “You know they could be doing something but you really don’t know for sure.”


Thompson gained 85 pounds between 2001 and 2004, according to Duke rosters and Thompson himself. He said he did not use steroids and was subjected to several tests while at Duke, a school where a single positive steroid test results in a yearlong suspension.


Meanwhile at UCLA, home of the laboratory that for years set the standard for cutting-edge steroid testing, athletes can fail three drug tests before being suspended. At Bowling Green, testing is voluntary.


At the University of Maryland, students must get counseling after testing positive, but school officials are prohibited from disciplining first-time steroid users. Athletic department spokesman Matt Taylor denied that was the case and sent the AP a copy of the policy. But the policy Taylor sent included this provision: “The athletic department/coaching staff may not discipline a student-athlete for a first drug offense.”


By comparison, in Kentucky and Maryland, racehorses face tougher testing and sanctions than football players at Louisville or the University of Maryland.


“If you’re trying to keep a level playing field, that seems nonsensical,” said Rannazzisi at the DEA. He said he was surprised to learn that what gets a free pass at one school gets players immediately suspended at another. “What message does that send? It’s OK to cheat once or twice?”


Only about half the student athletes in a 2009 NCAA survey said they believed school testing deterred drug use.


As an association of colleges and universities, the NCAA could not unilaterally force schools to institute uniform testing policies and sanctions, Wilfert said.


“We can’t tell them what to do, but if went through a membership process where they determined that this is what should be done, then it could happen,” she said.


‘Everybody around me was doing it’


Steroids are a controlled substance under federal law, but players who use them need not worry too much about prosecution. The DEA focuses on criminal operations, not individual users. When players are caught with steroids, it’s often as part of a traffic stop or a local police investigation.


Jared Foster, 24, a quarterback recruited to play at the University of Mississippi, was kicked off the team in 2008 after local authorities arrested him for giving a man nandrolone, an anabolic steroid, according to court documents. Foster pleaded guilty and served jail time.


He told the AP that he doped in high school to impress college recruiters. He said he put on enough lean muscle to go from 185 pounds to 210 in about two months.


“Everybody around me was doing it,” he said.


Steroids are not hard to find. A simple Internet search turns up countless online sources for performance-enhancing drugs, mostly from overseas companies.


College athletes freely post messages on steroid websites, seeking advice to beat tests and design the right schedule of administering steroids.


And steroids are still a mainstay in private, local gyms. Before the DEA shut down Alabama-based Applied Pharmacy Services as a major nationwide steroid supplier, sales records obtained by the AP show steroid shipments to bodybuilders, trainers and gym owners around the country.


Because users are rarely prosecuted, the demand is left in place after the distributor is gone.


When Joshua Hodnik was making and wholesaling illegal steroids, he had found a good retail salesman in a college quarterback named Vinnie Miroth. Miroth was playing at Saginaw Valley State, a Division II school in central Michigan, and was buying enough steroids for 25 people each month, Hodnik said.


“That’s why I hired him,” Hodnik said. “He bought large amounts and knew how to move it.”


Miroth, who pleaded no contest in 2007 and admitted selling steroids, helped authorities build their case against Hodnik, according to court records. Now playing football in France, Miroth declined repeated AP requests for an interview.


Hodnik was released from prison this year and says he is out of the steroid business for good. He said there’s no doubt that steroid use is widespread in college football.


“These guys don’t start using performance-enhancing drugs when they hit the professional level,” the Oklahoma City man said. “Obviously it starts well before that. And you can go back to some of the professional players who tested positive and compare their numbers to college and there is virtually no change.”


Maneafaiga, the former Hawaii running back, said his steroids came from Mexico. A friend in California, who was a coach at a junior college, sent them through the mail. But Maneafaiga believes the consequences were nagging injuries. He found religion, quit the drugs and became the team’s chaplain.


“God gave you everything you need,” he said. “It gets in your mind. It will make you grow unnaturally. Eventually, you’ll break down. It happened to me every time.”


At the DEA, Rannazzisi said he has met with and conducted training for investigators and top officials in every professional sport. He’s talked to Major League Baseball about the patterns his agents are seeing. He’s discussed warning signs with the NFL.


He said he’s offered similar training to the NCAA but never heard back. Wilfert said the NCAA staff has discussed it and hasn’t decided what to do.


“We have very little communication with the NCAA or individual schools,” Rannazzisi said. “They’ve got my card. What they’ve done with it? I don’t know.”


___


Associated Press writers Ryan Foley in Cedar Rapids, Iowa; David Brandt in Jackson, Miss.; David Skretta in Lawrence, Kan.; Don Thompson in Sacramento, Calif.;and Alexa Olesen in Shanghai, China; and researchers Susan James in New York and Monika Mathur in Washington contributed to this report.


___


Contact the Washington investigative team at DCinvestigations (at) ap.org.


Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the first of a two-part series.


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Drugs group Lundbeck’s shares hit by profit warning






COPENHAGEN (Reuters) – Shares in Danish drugs firm Lundbeck fell to their lowest level in over 12 years on Wednesday after it cut its profits forecast for the next two years as European sales slow and spending on new products rise to combat generic competition.


The company has already warned that earnings would stall until 2015 due to cheap generic competition for its existing drugs, meaning new products will be vital for future earnings.






But Chief Executive Ulf Wiinberg said on Wednesday that the negative impact on revenue from healthcare reforms in Europe had also been bigger than expected in the last two years and that slowing European sales and generic competition were hurting.


As a result the company said operating profits would fall further than previously forecast in 2014 as it increases investments in its late-stage drugs development pipeline and product launches.


Lundbeck is working to find new drugs to replace lost revenue from products coming off patent protection such as its antidepressant Cipralex, which is sold as Lexapro in the United States and Japan, and Alzheimer’s drug Ebixa.


Wiinberg said 2014 would be the company’s peak investment year for the new products pipeline, offering it a solid foundation for growth starting in 2015.


“You only get one chance to launch a product and we have to do it well,” Wiinberg said at a briefing for investors.


He was commenting after the company warned in a statement that it now expects revenue in 2014 of about 14 billion Danish crowns ($ 2.5 billion) and an operating profit of between just 0.5 billion and 1 billion crowns.


Analysts have on average been forecasting a profit of over 2.5 billion crowns for 2014 on turnover of over 14.7 billion crowns, according to Thomson Reuters I/B/E/S Estimates.


Two years ago Lundbeck predicted its annual revenues over the period 2012-2014 would exceed 14 billion crowns a year while earnings before interest and tax (EBIT) would exceed 2 billion crowns a year.


Next years’ revenue is now forecast to be in the range of 14.1 billion and 14.7 billion crowns to produce an operating profit of 1.6 billion to 2.1 billion crowns, with no change to the company’s forecast for 2012.


Analysts’ forecasts for this year are for operating profit to drop 41 percent to 1.99 billion crowns on revenue down 8 percent at 14.7 billion crowns, while for 2013 they predict a profit of 2.26 billion crowns on revenue of 14.5 billion crowns.


Lundbeck’s shares were trading down 17 percent at 79.90 crowns at 12.44 p.m. British time, dropping below 80 crowns for the first time since April 2000.


“In the short term, earnings are under pressure,” Sydbank analyst Soren Hansen said.


Lundbeck said that it expects a dividend payout ratio of about 35 percent of net profits in the 2012-14 period. Last year it paid 3.49 crowns on basic earnings per share of 11.64 crowns, a payout ratio of 30 percent.


Analysts have been predicting a 27-30 percent cut this year to 2.53-2.28 crowns, according to Thomson Reuters StarMine data.


But a number of analysts doubt that revenue from new products will be enough to secure revenue growth in 2015, compensating for lost revenue from Cipralex, Lexapro and Ebixa which together accounted for about 70 percent of group revenue in 2011.


Lundbeck is working on new products such as antidepressant Brintellix in Europe and the United States for launch at the end of next year or start of 2014, as well as alcohol dependency treatment Selincro in Europe in mid 2013.


“It is difficult to see revenue from the smaller products compensating for the large products,” said Hansen.


“They have a lot of new products in the portfolio and a lot of products in the pipeline, but revenue growth in 2015 is not very likely,” he said. ($ 1=5.6458 Danish crowns)


(Editing by Greg Mahlich)


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Merck, GE to collaborate on Alzheimer’s drug development






(Reuters) – Merck & Co and General Electric Co‘s healthcare unit have agreed to collaborate on an experimental drug for Alzheimer’s disease, the companies said on Tuesday.


GE Healthcare will supply Flutemetamol, an investigational imaging agent, to Merck for use with its experimental Alzheimer’s disease drug MK-8931.






The companies hope GE’s imaging agent will help identify patients who might benefit from a therapy such as Merck’s, which targets beta amyloid, a protein that can clump together and form plaques in the brain. Such plaques have been found in the brains of patients with Alzheimer’s disease.


MK-8931 is Merck’s lead Alzheimer’s drug candidate and is designed to modify progression of the disease as well as improve symptoms. Alzheimer’s robs patients of their memory and can cause other cognitive disturbances.


Based on promising results from an early-stage clinical trial of MK-8931, Merck plans to move forward with a larger trial, called EPOCH, at multiple sites around the world.


Flutemetamol is a positron emission tomography (PET) imaging agent that has been able, in clinical trials, to detect beta amyloid in the brain.


GE Healthcare will supply Flutemetamol to help select patients for clinical trials and evaluate the agent as a companion diagnostic tool. Financial and other terms of the agreement between the companies were not disclosed.


(Reporting By Toni Clarke; editing by John Wallace)


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Vivalis to buy Intercell in European biotech merger






LONDON/PARIS (Reuters) – France‘s Vivalis and Austrian vaccine specialist Intercell are linking up in a rare cross-border deal that shows the need for Europe’s fledgling biotech companies to grow in scale and produce a stronger pipeline to better compete in the quest for lucrative partnership deals.


Vivalis is set to buy Intercell in a deal valuing the Austrian vaccine maker at around 133 million euros ($ 174 million), and creating an enlarged anti-infectives specialist in the fragmented European biotech industry.






“Today it’s necessary to have critical mass in biotech,” Vivalis Chief Executive Franck Grimaud told Reuters. “Together, we will have all the know-how from drug discovery to product commercialization.”


Both companies are loss-making and the tie-up, billed as a merger of equals, will allow for cost savings of 5 million to 6 million euros a year, the companies said late on Sunday.


The combined group – to be known as Valneva, with listings in Paris and Vienna – also plans to raise 40 million euros via a rights issue to strengthen its balance sheet.


Former Vivalis shareholders will hold approximately 55 percent of the combined entity and Intercell investors 45 percent, immediately after the deal completes.


The combined company will be headquartered in Lyon, France, an establish centre for vaccines and infectious diseases research.


A number of corporate functions will remain at Intercell’s former base in Vienna and Vivalis’ offices in Nantes, north-western France.


STRATEGIC FIT


The decision to merge with Vivalis follows a difficult period for Intercell, which has a vaccine for Japanese encephalitis on the market but has been struggling to get back on track after a string of product setbacks.


For Vivalis, the acquisition offers an opportunity to accelerate its drive to establish a profitable business based on finished products.


Vivalis and Intercell first held talks over a possible combination a year ago, Franck Grimaud said.


Nomura Code analyst Gary Waanders said the two companies will benefit from merging their research and manufacturing activities as well as combined revenues from vaccines and technology licenses.


“We believe the combination of these companies, each experts in their fields, represents an excellent strategic fit which takes advantage of complementary skills and assets and provides a more resilient base for future growth than either company had alone,” Waanders said.


Intercell shares were trading 18 percent higher at 2.06 euros at 1257 GMT in Vienna, while Vivalis was over 7 percent lower at 6.83 euros on the Paris stock exchange.


A Paris-based trader attributed the Vivalis slump to a risk of dilution from the capital hike, which at 40 million is substantial for a group that will have a combined market capitalization of around 270 million.


“It’s also an interesting opportunity to get out of the stock for investors that bought it when it was worth 5 euros,” the trader added.


The French company’s primary expertise is in using technology based on stem cells from embryonic ducks. It licenses its EB66 cell line to pharmaceutical companies for the production of vaccines and drugs, including antibody-based treatments.


Thomas Lingelbach, the current chief executive of Intercell said the merger would bring together Vivalis’ technological know-how with Intercell’s product development and manufacturing experience.


Lingelbach will become CEO of Valneva, while Grimaud will become its chief business officer.


Under the terms of the deal, Intercell shareholders will receive 13 Vivalis new ordinary shares for 40 Intercell shares, representing a premium of 38.5 percent to the Austrian company’s closing share price on December 14, when the company was valued at 96 million euros, or 31.7 percent above the three-month average.


Intercell shareholders will also get 13 new preferred shares for 40 Intercell, with each preferred share to be converted into 0.481 new Valneva ordinary share in the event of successful approval of Intercell’s experimental Pseudomonas vaccine.


Societe Generale is advising Vivalis and Goldman Sachs International is working for Intercell on the deal, which is expected to be completed in May 2013.


(Reporting by Ben Hirschler and Elena Berton, editing by G Crosse)


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S.Africa’s Mandela had gallstones removed, recovering: government






JOHANNESBURG (Reuters) – Nelson Mandela, the 94-year-old former South African president and Nobel Peace laureate hospitalised with a lung infection, has successfully undergone a procedure to have gallstones removed, the government said on Saturday.


“The former president underwent a procedure via endoscopy to have gallstones removed. The procedure was successful and Madiba is recovering,” President Jacob Zuma‘s office said in a statement, using Mandela’s clan name.






South Africa‘s first black president, who came to power in historic all-race elections in 1994 after decades struggling against apartheid, remains a symbol of resistance to racism and injustice at home and around the world.


Mandela was admitted to a Pretoria hospital on Saturday a week ago after being flown from his home village of Qunu in a remote, rural part of the Eastern Cape province.


Tests revealed a recurrence of a lung infection and that he had developed gallstones, the government statement said.


The medical team had decided to treat the lung infection before attending to the gallstones, it said.


Mandela spent 27 years in apartheid prisons, including 18 years on the windswept Robben Island off the coast of Cape Town.


He was released in 1990 and went on to use his unparalleled prestige to push for reconciliation between whites and blacks as the bedrock of the post-apartheid “Rainbow Nation”.


He stepped down in 1999 after one term in office and has been largely removed from public life for the last decade.


Mandela spent time in a Johannesburg hospital in 2011 with a respiratory condition, and again in February this year because of abdominal pains. He was released the following day after a keyhole examination showed there was nothing serious.


He has since spent most of his time in Qunu.


His fragile health prevents him from making any public appearances in South Africa, although he has continued to receive high-profile domestic and international visitors, including former U.S. President Bill Clinton in July.


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School murders silence “cliff” rhetoric as deadline nears






WASHINGTON (Reuters) – Mass murder in Connecticut silenced “fiscal cliff” talk on Saturday as the White House and Congress quietly got ready for a final scramble to avert the tax hikes and spending cuts set for the New Year, with sessions of the U.S. House of Representatives now scheduled just days before Christmas.


President Barack Obama canceled a trip he had planned to make next Wednesday to Portland, Maine to press his case for tax hikes for the wealthy. His weekly radio and Internet address on Saturday focused on Newtown, the site of Friday’s school shootings, in which a gunman killed 20 children and six adults before taking his own life.






House Speaker John Boehner of Ohio canceled the standard Republican radio response to Obama “so that President Obama can speak for the entire nation at this time of mourning,” he said in a statement issued late Friday.


The moratorium on cliff pronouncements masked a growing recognition that the two sides could remain deadlocked at the end of the year on the key sticking point – whether to leave low tax rates in place except for high earners, as Obama wants, or extend them for all taxpayers, as Boehner wants.


With multiple polls showing that the public supports Obama’s position, Republicans in the U.S. Senate prodded their counterparts in the House to make a face-saving retreat, in a fashion that would allow Obama’s proposal to pass the Republican-controlled House while simultaneously letting Republicans cast a vote against it.


Republicans could then shift the debate onto territory they consider more favorable to them, cutting government spending to reduce the deficit.


“Just about everyone is throwing stuff on the wall to see if anything sticks,” one Republican aide said with reference to various proposals being discussed on how to proceed. Alluding to public opinion polls, the aide added: “We know if there is no deal, we will get blamed.”


“We could win the argument on spending cuts,” said a Republican senator who asked not to be identified. “We aren’t winning the argument on taxes.”


However, Republican leaders in both chambers are leery about seeming to cave on taxes. “There’s concern that if we did that, Obama would simply declare victory and walk away and not address spending,” said one aide. “We don’t trust these guys.”


Some of the prodding was coming from Senate Minority Leader Mitch McConnell of Kentucky.


Don Stewart, a McConnell spokesman, said the minority leader in the Democratic-controlled Senate hasn’t embraced any single plan, but has discussed and circulated measures offered by fellow Senate Republicans.


“Senator McConnell does not advocate raising taxes on anybody or anything,” Stewart said.


“We’re focused on getting a balanced plan from the White House that will begin to solve the problem of our debt and deficit to improve the economy and create American jobs,” said Boehner spokesman Michael Steel.


“Right now, all the president is offering is massive tax hikes with little or no spending cuts and reforms,” Steel said.


House Majority Leader Eric Cantor scheduled “possible legislation related to expiring provisions of law,” a reference to the expiring tax cuts, for the end of the week, portending a weekend session.


Cantor has said the House would meet through the Christmas holidays and beyond.


Hopes expressed after the November6 general election of some “grand bargain” on deficit reduction have all but disappeared, at least for this year. This is partly because time is running out and partly result of growing warnings from Democrats in Congress that they would not support big changes in the Medicare program, the government-run health insurance program for seniors that is a major contributor to the government’s debt.


House Democratic Minority Leader Nancy Pelosi of California ruled out one frequently mentioned proposal – raising the age of eligibility for Medicare, in a December 12 CBS television interview.


Asked if she was drawing a “red line,” around that idea, Pelosi said her comments were “something that says, ‘don’t go there,’ because it doesn’t produce money.


(Reporting by Thomas Ferraro and Kim Dixon; Editing by Fred Barbash and David Brunnstrom)


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U.S. to finalize stricter soot standards on Friday






WASHINGTON (Reuters) – The Obama administration will finalize stronger limits on harmful soot pollution from power plants and diesel engines on Friday, two health groups said.


The new standards, which the Environmental Protection Agency was under court order to finalize, will limit annual average soot emissions to about 12 micrograms per cubic meter of air from the standard of 15 micrograms set in 1997, the groups said.






Individual states will be responsible for deciding how to limit the emissions of fine particulates, which can threaten the elderly, people with heart disease and children.


When the EPA proposed the rules in June it said only six counties in California, Arizona, Alabama, Michigan and Montana are out of compliance with the standard. It also said the reduction in health bills from the standard would far outweigh the costs to industry.


(Reporting by Timothy Gardner; Editing by Gerald E. McCormick and Bob Burgdorfer)


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In challenge to personalized cancer care, DNA isn’t all-powerful






NEW YORK (Reuters) – The cancer cells were not behaving the way the textbooks say they should. Some of the cells in colonies that were started with colorectal tumor cells were propagating like mad; others were hardly multiplying. Some were dropping dead from chemotherapy and others were no more slowed by the drug than is a tsunami by a tissue. Yet the cells in each “clone” all had identical genomes, supposedly the all-powerful determinant of how cancer cells behave.


That finding, published online Thursday in Science, could explain why almost none of the new generation of “personalized” cancer drugs is a true cure, and suggests that drugs based on genetics alone will never achieve that holy grail.






Scientists not involved in the study praised it for correcting what Dr. Charis Eng, an oncologist and geneticist who leads the Genomic Medicine Institute at the Cleveland Clinic, called “the simple-minded” idea that tumor genomes alone explain cancer.


Calling the study “very exciting,” she said the finding underlines that a tumor’s behavior and, most important, its Achilles heel depend on something other than its DNA. Her own work, for instance, has shown that patients with identical mutations can have different cancers.


The core premise of the leading model of cancer therapy is that cells become malignant when they develop mutations that make them proliferate uncontrolled. Find a molecule that targets the “driver” mutation, and a pharmaceutical company will have a winner and patients will be cancer-free.


That’s the basis for “molecularly targeted” drugs such as Pfizer’s Xalkori for some lung cancers and Novartis’s Gleevec for chronic myeloid leukemia. When those drugs stop working, the dogma says, it is because cells have developed new cancer-causing mutations that the drugs don’t target.


In the new study, however, scientists found that despite having identical genetic mutations, colorectal cancer cells behaved as differently as if they were genetic strangers. The findings challenge the prevailing view that genes determine how individual cells in a solid tumor behave, including how they respond to chemotherapy and how actively they propagate.


If DNA is not the sole driver of tumors’ behavior, said molecular geneticist John Dick of the Princess Margaret Cancer Centre in Toronto, who led the study, it suggests that, to vanquish a cancer entirely, drugs will have to target their non-genetic traits too, something few drug-discovery teams are doing.


Genomes are what cutting-edge clinics test for when they try to match a patient’s tumor to the therapy most likely to squelch it.


For their study, Antonija Kreso, Catherine O’Brien and other scientists under Dick’s direction took colorectal cancer cells from 10 patients and transplanted them into mice. They infected the cells with a special virus that let them track each cell, even after it divided and multiplied and was transplanted into another mouse, then another and another, through as many as five such “passages.”


Only one in 10,000 tumor cells was responsible for keeping the cancer growing, the scientists found – in some cases for 500 days of repeated transplantation from one mouse to the next. Genetically-identical tumor cells stopped dividing within 100 days even without treatment.


Tumor cells that were not killed by chemotherapy – the scientists used oxaliplatin, a colon-cancer drug sold by Sanofi as Eloxatin – had the same mutations as cells that were. The survivors tended to be dormant, non-proliferating ones that suddenly became activated, causing the tumor to grow again. Yet the cells – dormant or active, invulnerable to chemo or susceptible – had identical genomes.


“I thought we’d be able to look at the genetics that let some cells propagate, or not be susceptible to chemotherapy, but lo and behold there was no genetic difference,” said Dick. “That goes against a main dogma of the cancer enterprise: that if a tumor comes back after treatment it’s because some cells acquired mutations that made them resistant.”


That’s true in some cases, he said, “but what our data are saying is, there are other biological properties that matter. Gene sequencing of tumors is definitely not the whole story when it comes to identifying which therapies will work.”


The results were surprising enough, Dick said, that experts reviewing the paper for Science asked him to run additional tests to make sure the cells that behaved so differently were in fact genetic twins. He did, they were, and Science accepted the paper.


Other experts also praised the work, saying it supported the growing suspicion in the field that personalized cancer therapy is oversimplistic, at least in how it’s sold to the public.


“It’s not as simple as just sequencing mutations to tailor therapies to each tumor,” said surgical oncologist Dr. Steven Libutti of the Montefiore Einstein Center for Cancer Care in New York City. “In my mind, the findings are not unexpected. Other things besides genes matter: the environment in which a tumor is growing, for instance, plays an important role in whether therapy will be effective.”


Rather than targeting DNA alone, the Toronto scientists suspect, effective therapies would also take aim at what phase of its cycle a cell is in (dormant, growing or dividing, for example), which of its genes are activated, whether it sits in a region of the tumor that is starved of oxygen, and other non-genetic properties.


Nudging tumor cells out of their dormant phase and into their growth cycles, for instance, could make them more susceptible to chemotherapy, which generally targets rapidly dividing cells.


“Our findings raise questions about the resources put into sequence, sequence, sequence,” said Dick. “That has led to one kind of therapeutic” – molecularly-targeted drugs – “but not the cures the public is being promised.”


(Reporting by Sharon Begley; editing by Claudia Parsons)


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