Popular wisdom has long held that young children survive traumatic events better than adults do, in part because they suffer less. Being too young to understand fully the nature of what’s happening around them - during war or natural disaster, for instance - they should bounce back with much more resilience.

But new research on child survivors of Hurricane Katrina and witnesses of the 9/11 terrorist attacks suggests otherwise. “There is increasing evidence that kids know what is going on if they are directly exposed and see something like planes crashing into the [World Trade Center] towers,” says child psychologist Claude Chemtob of New York University, lead author of one of several new papers on children and disaster, published in a special section of the July and August issue of Child Development. (See the top 10 scientific discoveries of 2009.)

Together, the new studies show that young children and teens not only exhibit symptoms of posttraumatic stress and depression that are similar to those of adults, but that they may react more strongly to trauma because adults do. They also show that younger children and girls are more likely to develop symptoms of posttraumatic stress disorder (PTSD) than boys and older kids.

In the first two studies, researchers analyzed the long-term effects on children and their parents of the 9/11 attacks. In one analysis, led by Chemtob, researchers followed 116 preschool children and their mothers in Lower Manhattan who had been directly exposed to the World Trade Center attacks. Interviews were conducted with the mothers and with the children’s preschool teachers nearly three years after 9/11. (See pictures of the World Trade Center’s destruction.)

Chemtob found that compared with children whose mothers did not report symptoms of PTSD or depression, those whose mothers were affected were three times more likely to be emotionally reactive - being clingy and quick to become upset - and seven times more likely to exhibit aggressive behavior three years after the traumatic events. “Kids are very attuned to their moms because moms send cues to their kids about what’s safe and what’s not. If Mom is less available and more focused on the fearful aspects of life, then she is not helping,” Chemtob says. (Comment on this story.)

In contrast, a second study on 9/11 that looked at more than 400 children, aged 12 to 20, and their mothers, found that those who were directly exposed to the attacks - those who witnessed the planes hit the towers, for example - were only slightly more likely to suffer PTSD than children who did not directly experience the trauma, but were significantly more likely to be depressed. Only 4% of these children had PTSD 15 months after the attacks, but 12% were depressed.

Notably, this study, led by child-development researcher Elizabeth Gershoff of the University of Texas at Austin, mirrors the findings of a 2008 study that Chemtob conducted with the same group of children involved in his current paper. In the 2008 study, he also found that children who were directly exposed to the events of 9/11 - seeing dead or injured people, watching people jump out of a building or witnessing a tower collapse - were three times more likely to be depressed or anxious than those who were not directly exposed. “We have tended to say that young kids don’t need help, but in fact they are very vulnerable,” says Chemtob. (See pictures of an army town coping with PTSD.)

Chemtob’s and Gershoff’s conclusions are further supported by two other studies appearing in the current issue of Child Development on the child survivors of Hurricane Katrina. In the first study, a team of researchers from Louisiana State University (LSU) interviewed 387 public schoolchildren in St. Bernard Parish, one of the areas most devastated by Katrina, and found that young children were more profoundly affected than adolescents. Three years after the hurricane, children between the ages of 9 and 11 were four times more likely to show symptoms of PTSD than were teenagers between the ages of 15 and 18.

Although the study reported that behavioral problems among the study sample had decreased overall over time - with nearly half of the children showing no lasting signs of stress - more than 25% of the younger kids were still exhibiting significant symptoms of PTSD and depression, such as feeling sad or nervous and having trouble sleeping or concentrating.

It may be that older children had more emotional resources to call on, which made it easier for them to bounce back. “Whereas younger children are more dependent on their caretakers, adolescents can turn to their friends or others in the community,” says Joy Osofsky, a child psychologist at LSU who co-authored the study. Indeed, the children who fared best post-Katrina were those whose schools were quickly rebuilt and who had supportive relationships, both at home and at school. (Read “Study Points at a Clear-Cut Way to Diagnose PTSD.”)

Despite the age advantage, girls of any age were twice as likely as boys to have problems adapting after the disaster - an effect reported by both Osofsky’s current research as well as several prior studies. One explanation, put forth by the second Katrina study in Child Development, is that girls may simply be more expressive of their feelings of stress than boys are, even if boys have the same emotions. In the study, which analyzed saliva samples from 62 boys and girls between the ages of 12 and 19 who had been relocated to camps after the hurricane, researchers found no significant difference in levels of salivary cortisol, a hormone associated with stress, between the genders.

Jacob Vigil, a psychologist at the University of New Mexico and lead author of the study, hypothesizes that the differences in the way boys and girls react to trauma may be due to social conditioning rather than actual physiological effects. It may also be possible that similar levels of stress hormones affect males and females differently.

Past studies have shown that PTSD is more likely to manifest itself in boys as concentration and behavioral problems, while girls tend to exhibit emotional reactions like guilt and anxiety. “Girls tend to internalize their problems, whereas boys are more likely to act out,” says Gershoff. Other common symptoms of the disorder may include nightmares, upsetting thoughts about the past trauma, avoidance of reminders of the event and persistent worrying about more bad things happening.

Although there was no significant difference in the levels of cortisol in boys and girls in Vigil’s study, he did note that cortisol levels in the traumatized population of kids living in relocation camps were lower on average than those of a control group. That suggests the Katrina survivors had lived with constant stress for so long that they had become almost inured to its effect - they became less reactive to relatively minor, day-to-day stressors. “It’s like a rubber band that gets stretched too much. Folks who are not reactive to stress seem to have more stress in their life,” notes Vigil. Low cortisol levels have been associated with depression in adults, and while depression is a separate condition from PTSD, they share many of the same symptoms such as trouble sleeping and concentrating.

Child advocates say that one way to minimize long-term PTSD in kids is to provide them with the same level of psychological support that is regularly offered to adults. “It is important that kids have access to mental-health services right after a disaster,” says Gershoff. “We can’t just assume that kids are going to get over it. They need someone who can help them cope,” especially when their parents can’t.

Technorati Tags: posttraumatic depression, posttraumatic stress

Eisai Co and Pfizer Inc said they won U.S. regulatory approval for a higher dose once-daily version of Aricept, a drug that treats Alzheimer disease.

Eisai, Japan’s No. 4 drugmaker, said in March it expected annual U.S. sales of the drug, its flagship product, to fall 60 percent to $800 million from $2 billion between 2011 and 2013 with the expiration of its patent for the drug looming.

The U.S. Federal Drug Administration approved a 23 mg tablet version of the drug, which treats moderate-to-severe Alzheimer’s. About 3.5 million Americans over the age of 65 suffer from the disease.

(Reporting by Phil Wahba; editing by Carol Bishopric)

Technorati Tags: Alzheimer disease, Aricept, Eisai Co, Pfizer Inc

The cancer drug Avastin, when used in combination with standard chemotherapy, is safe and can effectively treat an advanced form of one of the most common lung cancers, researchers report.

Previously it had been thought that this combination might have serious adverse side effects, including life-threatening bleeding, for patients with non-squamous non-small-cell lung tumors. However, this phase 4 trial, which used Avastin (bevacizumab) plus chemotherapy in a large population found these problems were minimal.

Phase 4 trials are done after a drug is on the market, to look for any new problems.

“Today we have a new option to treat non-squamous lung cancer, incorporating Avastin in chemotherapy regimens and in maintenance therapy,” said lead researcher Dr. Lucio Crino, director of medical oncology at S. Maria della Misericordia Hospital in Perugia, Italy.

“The practical implication is the possibility to incorporate Avastin with any chemotherapy regimen in the frontline therapy of metastatic non-squamous lung cancer,” he added.

The report, which is funded by the maker of Avastin, F Hoffman-La Roche Ltd., is published in the July 20 issue of The Lancet Oncology. The funder was involved in study design, coordination of data collection, data analysis, data interpretation, and writing of the report, the journal noted.

Advanced non-small-cell lung cancer is a common cancer that kills 1.18 million people every year worldwide, according to background information in the study. Avastin is a so-called monoclonal antibody that works by blocking vascular endothelial growth factor A, which stimulates the growth of the tumor’s blood supply.

When used as an adjunct to chemotherapy, Avastin had already shown cancer-fighting activity in two phase 3 trials, the researchers noted.

For the study, Crino’s team studied Avastin in more than 2,200 patients with advanced or recurrent non-squamous non-small-cell lung cancer. The patients were treated at centers in 40 countries around the world.

These patients were given the drug every three weeks along with standard chemotherapy, for up to six cycles. Patients were then treated with Avastin alone until the cancer began to progress (”maintenance” therapy).

The researchers reported few clinically significant adverse events, meaning that most were no greater than what one would expect in the general population. One percent of patients experienced bleeding in the lungs and 4 percent had bleeding, Crino’s group found.

Overall, 3 percent of the patients died due to adverse events associated with Avastin. These included 1 percent who had blood clots and 1 percent who suffered bleeding.

Other serious adverse events associated with Avastin were blood clots in the lungs and nosebleeds, low white blood cell counts, fever along with a low white blood cell count and deep vein thrombosis (DVT), all of which occurred in 1 percent of the patients.

Dr. Robert Pirker, from the department of medicine at the Medical University of Vienna in Austria, and author of an accompanying journal editorial, said that Avastin “can be safely given when certain precautions are taken.”

However, several issues remain to be determined, including the optimal dose and the role of maintenance therapy with Avastin, he said.

“In addition, it is unknown whether bevacizumab [Avastin] increases survival when added to cisplatin-based chemotherapy in patients with advanced non-squamous non-small-cell lung cancer,” Pirker said.

Overall, Avastin, like several other targeted agents have led to therapeutic advances in lung cancer, he added. “Hurdles in clinical development do occur but — as shown for bevacizumab — can be overcome,” Pirker said.

Another expert, Dr. Norman H. Edelman, chief medical officer at the American Lung Association, and professor of preventive medicine, internal medicine, physiology & biophysics at Stony Brook University in New York, called the study “very good bread-and-butter clinical research.”

The efficacy of the drug has been proven previously, he noted, but this study provides an in-depth analysis of Avastin’s safety profile under “real life” conditions, he added.

“Too often this step is shortcircuited in the rush to market of a new drug and we have to await the laborious collection of after-market data to find the real dangers of many new drugs,” Edelman said.

“So, the researchers and sponsors are to be congratulated for doing this study. They find that there are real deleterious side effects but that they are manageable, and conclude the drug is worth using under the proper circumstances,” he said.

Avastin is in the spotlight Tuesday for another reason, as well. U.S. regulators could rescind approval of the drug for the treatment of breast cancer, based on follow-up studies reported Friday that failed to show the medication shrank tumors or extended lives, according to published reports.

The Food and Drug Administration on Tuesday will ask a panel of outside experts to review the evidence on the Roche drug, the Associated Press said. It’s possible the FDA will withdraw approval of Avastin as a breast cancer treatment.

The drug is also approved for lung, colon, brain and kidney cancer.

Technorati Tags: Advanced Lung Cancer, Avastin

An experimental obesity drug, taken along with formal counseling on lifestyle changes, may spur greater weight loss than counseling alone, a new study finds.

The study of nearly 800 obese adults examined the effects of a drug called Contrave — which combines the antidepressant bupropion (Wellbutrin) and naltrexone, a medication used to treat alcohol and drug addiction.

The trial is one of four studies that the drug’s developer, Orexigen Therapeutics, has sponsored in a bid to win approval from the U.S. Food and Drug Administration (FDA).

The other trials have so far shown that Contrave generally outperforms placebo pills in spurring weight loss; in one, for instance, study participants on the drug lost an average of 6 percent of their initial weight over one year, compared with just over 1 percent among placebo users.

The current findings support the previous results, and suggest that combining the medication with counseling on diet and lifestyle would provide further benefits, the researchers report in the journal Obesity.

They found that over one year, participants in the drug-plus-counseling group lost 9 percent of their initial weight, on average — versus an average of 5 percent among those who received behavioral counseling plus a placebo.

Orexigen recently filed for FDA approval of Contrave and has said that it expects the agency to give a ruling early next year.

The drug is one of three experimental weight-loss medications currently under FDA scrutiny. Later this week, an advisory panel to the agency is set to review Qnexa, a weight-loss drug developed by Vivus Inc. The drug combines phentermine, an appetite suppressant, with topiramate, an epilepsy medication that also happens to help control appetite. In documents made public on Tuesday, FDA staff said Onexa appears to help people shed pounds, but concerns remain about its safety.

The third candidate drug — lorcaserin, developed by Arena Pharmaceuticals Inc. — acts on certain receptors in a portion of the brain that regulates appetite and metabolism.

For its part, Contrave is believed to act on brain pathways involved in food craving.

These latest findings are based on 793 obese men and women who were randomly assigned to take either Contrave or a placebo for one year in addition to 28 sessions of group counseling on diet, exercise and behavioral tactics for encouraging weight loss — like eating more slowly and avoiding temptations.

Researchers led by Dr. Thomas A. Wadden, of the University of Pennsylvania in Philadelphia, found that after 56 weeks, the Contrave group shed more pounds overall. Just over 41 percent lost 10 percent or more of their starting weight, versus 20 percent of the placebo group; 29 percent lost at least 15 percent of their initial weight, compared with 11 percent of placebo users.

It remains to be seen what role, if any, Contrave or its would-be competitors might have in battling obesity, which now affects about one-third of U.S. adults.

Weight-loss drugs have had a troubled history, starting in 1997 when the medication known as “fen-phen” was withdrawn from the market after being linked to fatal heart-valve problems.

One component of that medication, fenfluramine, was taken off the market; the other, phentermine (now a component of Qnexa) is generally considered safe at low doses.

There are currently two weight-loss medications FDA-approved for longer-term use: sibutramine (Meridia) and orlistat (Xenical), the latter also being available in a lower-dose, over-the-counter version called Alli.

Those medications have had their problems as well. Meridia carries warnings about high blood pressure and a risk of heart attack and stroke in patients with heart problems, and is no longer sold in Europe. Xenical can cause serious liver problems, uncontrolled bowel movements and gas.

Among the side effects so far seen with Contrave are nausea, constipation, dizziness, abdominal pain and ringing in the ears. In the current study, 34 percent of Contrave users reported nausea, while one-quarter reported constipation — compared with 10 percent and 14 percent, respectively, in the placebo group.

The side effects were reported mainly during the first month of treatment, according to Wadden’s team.

Besides the issue of side effects, experts generally caution people to temper their expectations regarding the effectiveness of any weight-loss drug. They stress that none is considered a “magic pill” that will work without the help of diet changes and regular exercise.

One of the FDA criteria for judging a weight-loss medication effective is that its average weight loss beat a placebo by 5 percentage points, which is a relatively modest benefit.

Still, research indicates that even moderate weight loss — 5 to 10 percent of a person’s starting weight — can have health benefits for someone who is obese.

In the current study, Contrave users saw, along with their greater weight loss, a larger reduction in triglycerides (a type of blood fat) and insulin levels, and a greater gain in “good” HDL cholesterol levels.

SOURCE: http://link.reuters.com/byx37m Obesity, online June 17, 2010.

Technorati Tags: Contrave, naltrexone, obesity drug, Weight Loss, wellbutrin

Clinical trials aimed at pinpointing emerging safety problems with drugs already on the market should only be conducted when other, less invasive research is not possible, a U.S. advisory group said on Friday.

The Institute of Medicine’s report, requested by U.S. Food and Drug Administration officials, comes ahead of a highly-anticipated meeting next week on GlaxoSmithKline Plc’s diabetes drug Avandia, that has come under fire for potential heart risks.

Glaxo is conducting a randomized, controlled trial called TIDE to compare Avandia to Takeda Pharmaceutical Co’s rival drug, Actos, after safety concerns emerged with Avandia that the FDA and its advisers concluded were unclear.

While the IOM did not target the Avandia trial in particular, FDA Commissioner Margaret Hamburg asked the independent, nonprofit medical group to weigh in with at least an initial finding on general ethical issues involving the safety of studying the risks of drugs already in use.

The FDA called in 2007 for the TIDE study, which aims to enroll 16,000 patients and end in 2015, although some critics say it could take longer.

Analyses of other data since then have convinced some researchers that Avandia’s risks are greater than those of Actos and have repeatedly called for the trial to be halted.

Glaxo has defended its drug, saying data overall shows it does not increase the risk of heart attack, stroke or death.

On Tuesday and Wednesday, FDA’s panel of outside experts will weigh numerous studies and analyses before recommending whether Avandia should remain on the market, be pulled from the market, or various options in between.

They also will be asked to weigh in on the TIDE trial.

In its report, the IOM said randomized controlled trials should only be done when “a responsible policy decision cannot be made based either on the existing evidence or on evidence from new observational studies.”

It also said studies of real world use of a drug — known as observational studies and often done by reviewing insurance claims and other databases — can yield strong data.

In separate FDA documents released on Friday, FDA staff scientists were split over whether the TIDE trial should continue just as they are divided over whether another major Glaxo trial, RECORD, showed excessive heart-attack risks with Avandia.

Some staff also pointed to studies done since 2007, including an FDA analysis of 52 trials on the prescription drug, as well as a review of Medicare data that showed a greater risk of heart attack and other complications with Glaxo’s drug.

“Based on these findings, any proposed head-to-head trial of rosiglitazone vs. pioglitazone is unethical and exploitative,” agency reviewers David Graham and Kate Gelperin wrote.

Rosiglitazone is the generic name for Avandia, and pioglitazone is the generic name for Actos.

Another FDA scientist, clinical reviewer Karen Mahoney, said that the TIDE trial does not have many of the limitations of the earlier RECORD study and could be illuminating.

“This trial, if it continues to completion, has the potential to address the question of the cardiovascular safety of rosiglitazone more definitively,” she wrote in a separate memo.

(Reporting by Susan Heavey; Editing by Tim Dobbyn)

Technorati Tags: Actos, Avandia, drug safety trials, pioglitazone, Rosiglitazone

The U.S. House of Representatives has approved a ban on some patent agreements between brand name and generic drug companies, deals which a federal agency says slow the arrival of cheaper generic drugs to market.

The House, voting late on Thursday, approved the measure as part of its approval of money to pay for President Barack Obama’s Afghanistan troop increase.

The measure, backed by the Federal Trade Commission, must now be considered by the Senate. The U.S. House has approved the measure previously but it has died in the Senate.

The Generic Pharmaceutical Association (GPhA) said it was disappointed in the vote.

“As this legislation moves to the Senate, GPhA will expand its efforts to point out that a curb on settlements will not hasten generic market entry, but rather will delay the launch of new and affordable generic medicines,” the group said.

“The unintended consequence of these restrictions on settlements will significantly harm the millions of Americans who rely on generic drugs,” it said in a statement.

But the House move pleased FTC Chairman Jon Leibowitz, who has made stopping the deals a centerpiece of his tenure on the commission. The FTC says the deals break antitrust law in instances where brand name drug companies essentially pay generic companies to delay entering the market.

“Congress has taken a critical step toward ending a practice that is dramatically increasing the cost of prescription drugs,” said Leibowitz.

The FTC has estimated that the deals — which often come as part of settling patent litigation — cost consumers about $3.5 billion a year by delaying access to generics.

(Reporting by Diane Bartz; Editing by Tim Dobbyn)

Technorati Tags: brand name drug, cheaper generic drugs, drug patent, generic drug, generic medicines, prescription drugs

A new study led by a federal drug safety expert ties the controversial diabetes drug Avandia to a higher risk of heart problems, strokes and deaths in older adults, and says it is more dangerous than a rival drug Actos.

The study, a huge review of Medicare records, comes two weeks ahead of a Food and Drug Administration hearing on Avandia’s safety. The lead author, Dr. David Graham, is an FDA scientist who wants the pill banned.

As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, Graham said in an interview with The Associated Press.

Harms from Avandia are great enough to “put you in a hospital or in a cemetery,” he said.

Editors at the Journal of the American Medical Association rushed to release the study online on Monday, so the information would be available before the July 13-14 hearing, a spokeswoman said.

Avandia is a once-blockbuster drug for Type 2 diabetes, the most common form of the disease and the kind often tied to obesity. Avandia and Actos are pills that help the body make better use of insulin, a key digestive hormone.

The American Heart Association issued a statement reminding patients not to stop taking any medicine without talking with their doctors first. The new study is not definitive enough to prove harm but “deserves serious consideration” and should be discussed between patients and their doctors, the statement says.

Avandia has been under a cloud since May 2007, when a review of dozens of studies suggested it may raise the risk of heart attacks and heart-related deaths. Warnings were added to its label, and the American Diabetes Association told patients to avoid using it until safety questions were resolved.

The FDA and Congress have held meetings on the drug but it has remained on the market, still used by hundreds of thousands of Americans.

Avandia’s maker, the British company GlaxoSmithKline PLC, maintains that its drug is safe. A spokeswoman said the new study has limitations, and that the company looks forward to a full discussion of evidence at the FDA hearing.

The study involved 227,571 Medicare patients, average age 74, who started on Actos or Avandia from July 2006 through June 2009 and were followed for three years on average.

Avandia patients were 27 percent more likely to suffer strokes, 25 percent more likely to develop heart failure and 14 percent more likely to die than those on Actos, researchers found.

There were 2,593 heart attacks, heart failure cases, strokes and deaths among the 67,593 Avandia users, and 5,386 of those problems among the 159,978 people taking Actos. Just dividing these numbers to compare side effect rates can’t be done, though, because people were on the drugs for differing lengths of time.

Unlike studies in younger patients that implicated Avandia, heart attack risks were similar in both groups in the Medicare study. Sudden cardiac deaths are much more common in older adults, and whether Avandia affects heart risks differently in older versus younger patients is unknown, the researchers note.

The findings suggest that if 60 people were treated with Avandia for one year, one extra case of heart failure, stroke or death would occur that could have been avoided if they’d taken Actos instead, Graham said.

“The evidence is overwhelming,” he said. “There is not a single study where those two drugs are compared where Avandia doesn’t look worse than Actos. How many studies do you have to do before you come to your senses?”

The study was observational, with the researchers examining data on patients whose doctors had prescribed Avandia or Actos. That’s less rigorous than studies that randomly assign patients to take different drugs, and therefore cannot prove that the drug is riskier.

But Dr. Alvin Powers, a diabetes specialist at Vanderbilt University, called it “important information that’s consistent with prior studies,” even if it is not definitive. He said he doesn’t prescribe Avandia because of uncertainty over its safety.

Another AMA journal, Archives of Internal Medicine, on Monday released online an expanded analysis by the same authors who did the original one in 2007; both suggest higher heart risks for Avandia.

At its hearing next month, the FDA plans to examine the latest safety data and air internal disagreement among its scientists over what should be done.

At the FDA’s request, Glaxo began a big study last year comparing heart and stroke risks in patients on Avandia or Actos, made by Japan’s Takeda Pharmaceuticals. It aims to enroll thousands of patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study continue.

The editorial, by Dr. David Juurlink of the University of Toronto, says it is hard to understand why patients and doctors would choose Avandia when a safer alternative exists. He led a previous study of elderly diabetics in Ontario that also found higher risks with Avandia versus Actos.

Technorati Tags: Actos, Actos side effects, Avandia, Avandia side effects, diabetes drugs

They’re out there on the Web: Sites that offer tips to successful purging or water-only fasts; others that list methods of hiding rapid weight loss from parents and doctors.

If the proliferation of these pro-anorexia and pro-bulimia Web sites isn’t bad enough, eating disorder experts say they now have to contend with “pro-ana” and “pro-mia” bloggers and “thinspiration” Twitter updates sent right to an interested party’s mobile phone.

“They are reaching very vulnerable youth,” said Dina Borzekowski, an associate professor in Johns Hopkins Bloomberg School of Public Health. “When you have the Internet used all times of the night, kids have easy access to it. It’s anonymous. They can gain support for what they’re doing and information.”

For their new study, Borzekowski and colleagues conducted a systematic review of 180 pro-eating disorder sites. What they found was both surprising and frightening.

About 91 percent of sites were open to the public — though many warned that “wannabes” should stay away — and about 79 percent had interactive features, such as calorie and body-mass index (BMI) calculators.

About 16 percent had a “creed” or “oath to Ana,” such as the “Thin Commandments,” or 10 rules for eating disorders, such as: “Thou shall not eat without feeling guilty,” “Thou shall not eat fattening food without punishing oneself afterward,” and “What the scale says is the most important thing.”

About 42 percent provided a venue for posting artwork and poetry, some of it disturbing:

“some look at us and call us crazy
how little they really know
they pass us by and stare
like we’re in some sickly show
don’t they see?
It is not us who is at fault
They kill their bodies with fats and grease
but we give our bodies nothing at all.”

“Thinspiration,” such as photos or videos of very thin models and actresses, were on 85 percent of the sites. And about 43 percent provided specific instructions on concealing eating disorders, according to the study.

Patients with eating disorders have been known to go to great lengths to hide their weight loss, explained Dr. Ira Sacker, an eating disorder specialist, including drinking lots of water before being weighed and hiding weights in their clothes.

About one-third of sites did include information about recovery or treatment, though only 13 percent of sites contained an overt statement that eating disorders are a problem.

“Some people who create these messages stand behind what they are doing, while another fraction realize this is troubling and they are suffering,” Borzekowski, said. “You get mixed messages.”

The study is published in the June 17 issue of the American Journal of Public Health.

Previous research suggests that teens exposed to pro-eating disorder Web sites do have higher levels of body dissatisfaction compared to adolescents that have not been exposed. Other studies found that teens who spent time on these sites tend to have harder-to-treat eating disorders, according to background information in the study.

Sacker has been treating patients with eating disorders for some 40 years. He can remember his dismay when he first started seeing pro-eating disorder sites pop up in the early 1990s.

“These are really scary,” Sacker said. “The people on these sites want to be using the eating disorder as their identity, and they want to communicate with others like them. That makes them believe there is a safety in it and a community behind it, which reinforces that what they are doing is OK. It’s almost like a cheerleading group.”

In 2001, the search engines Yahoo and MSN agreed to shut down overtly pro-eating disorder sites, according to background information in the article.

It didn’t make much of a dent, Sacker said. Over time, online offerings for those with eating disorders have only gotten more sophisticated. The text and a photos of skeletal models has morphed into videos, voice-overs, blogs and Facebook groups.

“Parents need to be aware and have boundaries about what their kids are doing on Facebook or on these sites,” Sacker said. “Even though some sites talk about recovery, the majority can worsen or prolong the illness.”

Though there are many exceptions, the typical profile of someone with an eating disorder is a highly intelligent, motivated perfectionist who “feels they are not good enough, no matter what they do, and are looking for some form of control,” Sacker said.

The content of pro-eating disorder sites reflected those themes, with 83 percent talking about “success,” 81 percent “control,” 80 percent “perfection” and 76 percent “solidarity,” according to the paper.

People with eating disorders may also have depression, anxiety and obsessive-compulsive disorder or other mental health conditions.

The obsession with weight loss obscures all else, Sacker said. “They become totally preoccupied by looking at mirrors. They know more about nutrition than most nutritionists. They lose friends and become socially isolated because of it,” Sacker said.

Medications, including mood stabilizers, anti-anxiety drugs and antidepressants can help some with eating disorders, Sacker said.

Technorati Tags: eating disorders, pro eating disorder, rapid weight loss, Weight Loss

A pink pill designed to boost sex drive in women — the latest attempt by the drug industry to find a female equivalent to Viagra — fell short in two studies, federal health regulators said Wednesday.

The Food and Drug Administration is considering Boehringer Ingelheim’s drug flibanserin for premenopausal women who report a lack of sexual desire, a market that drugmakers have been targeting for more than a decade since the blockbuster success of Viagra in men.

The search for so-called “female Viagra,” has proved elusive though, with many drugs abandoned after showing lackluster results.

On Friday the FDA will ask a panel of experts to weigh in on the safety and effectiveness of Boehringer’s drug. The agency is not required to follow the group’s advice, though it often does.

In its review posted online, the FDA said two Boehringer studies failed to show a significant increase in sexual desire, as recorded by women in a daily journal. Women taking the drug reported slightly more sexually satisfying experiences, but FDA said that was not the primary measure of the study.

“The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not,” states the FDA review.

The FDA also noted increased side effects like depression, fainting and dizziness seen among women taking the pink pill.

The drug, which is related to the antidepressant family, affects serotonin and several other brain chemicals, though it’s not clear how that increases sex drive.

“We don’t know specifically what the exact mechanism of action is but we believe it acts on brain chemicals that have a role in human sexual response,” said Dr. Peter Piliero, executive director for Boehringer’s U.S. medical affairs.

Since the launch of Viagra in 1998, more than two dozen experimental therapies have been studied for so-called “female sexual dysfunction,” a market which some analysts estimate at $2 billion.

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, says arousal in women is so complicated that it may be unrealistic to expect a pill to completely address sexual problems.

“It’s a fairly complicated area, unlike in men’s sexual dysfunction where there’s a major mechanical concern,” said Kavaler. “In women there’s no mechanical concern, so if she’s not having a successful sex life, where is the problem?”

Pharmaceutical approaches to boosting female libido have evolved over time. Initially, most treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave of would-be blockbusters focused on boosting hormones, including testosterone, which is linked to sexual interest. Flibanserin is the first drug to approach the problem through brain chemistry.

The FDA has approved an unusual handheld vacuum device that increases blood flow to the clitoris to increase sexual arousal. But all drug therapies have fallen short so far.

In 2004, Pfizer halted its study of Viagra in women due to inconclusive results. Later that year an FDA panel rejected Procter & Gamble’s testosterone patch Intrinsa, due to potential risks of heart disease and cancer. Smaller companies are currently developing creams and nasal sprays to increase female libido.

BioSante Pharmaceuticals Inc. expects to submit its testosterone gel LibiGel for FDA approval next year.

Medical surveys have estimated more than 40 percent of women suffer from some form of sexual dysfunction; Boehringer estimates as many as one in 10 women could be helped by its drug.

Boehringer tried to zero in on the chemical aspect of sexual dysfunction by only testing its drug on premenopausal women who were in stable relationships and not taking other medications. Despite wanting to have a sexual relationship, the women enrolled in company studies reported a persistent lack of desire that caused them “distress or interpersonal difficulty.”

Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, believes drugmakers have oversimplified female sexuality. She says in most cases lack of sex drive has more to do with the quality of one’s relationship and lifestyle than brain chemicals.

During the public comment period at Friday’s meeting, Tiefer will ask the FDA to reject flibanserin, arguing it offers meager benefits for women with unknown long-term risks.

The modest results reported by Boehringer have also cooled Wall Street’s expectations for the drug.

Decision Resources analyst Alasdair Milton said he expects flibanserin sales to peak at $300 million after six or more years on the market. By comparison, male sexual dysfunction drugs including Viagra, Cialis and others posted combined sales of $4.4 billion last year, according to health care data firm IMS Health.

Privately-held Boehringer Ingelheim posted sales of $12 billion last year. The Ingelheim, Germany -based company makes a range of prescription drugs for heart disease, HIV and other diseases.

Technorati Tags: BioSante Pharmaceuticals, Boehringer, female sexual dysfunction, female viagra, pink pill, prescription drugs, Viagra

Swiss drugmaker Novartis AG won wider U.S. approval for its leukemia drug Tasigna to treat a rare form of the blood cancer at an earlier stage of the disease, the Food and Drug Administration said on Thursday.

Tasigna had previously been approved to treat adults with chronic myeloid leukemia, or CML, in patients who could not tolerate or were no longer responding to treatment with Gleevec, an older but highly effective Novartis drug.

The new approval could lead to significantly higher sales of Tasigna, known chemically as nilotinib.

In a clinical study presented at a major cancer meeting earlier this month, Tasigna fared better than Gleevec in a head-to-head trial, paving the way for the expanded approval.

About 44 percent of patients taking the newer Novartis pill had a major molecular response compared with 22 percent for Gleevec after 12 months.

A major molecular response is defined by a reduction of disease by 99.9 percent and has been associated with higher rates of long-term survival.

The side effects, or toxicity, seen with Tasigna were less severe than with Gleevec in the head-to-head study, researchers said when presenting the data.

Both Tasigna and Gleevec belong to a class of drugs called tyrosine kinase inhibitors, which deactivate messages that make leukemia cells malignant and kills them.

Bristol-Myers Squibb Co is hoping to win earlier stage approval for its similar CML drug Sprycel, which also topped Gleevec in a recent head-to-head trial.

Any long-term survival improvement the newer drugs can demonstrate over Gleevec would be impressive. The older drug increased the CML 10-year survival rate from less than 20 percent to up to 90 percent and transformed CML from a death sentence to a manageable disease for most patients.

“It’s important for companies to continue developing oncology drugs for earlier stages of the disease once they have demonstrated clinical effectiveness in resistant forms of cancer,” Dr Richard Pazdur, director of the Office of Oncology Drug Products for the FDA’s Center for Drug Evaluation and Research, said in a statement.

“This approach has the potential to increase the availability of an effective treatment to more patients,” he added.

(Reporting by Bill Berkrot; Editing by Tim Dobbyn)

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