Kids given healthier snacks eat fewer calories

- Kids given a combination of cheese and vegetables will eat only about a quarter as many calories as those given potato chips, according to a new study.
"Like it or not, children like foods that are energy-dense and not those that are nutrient-rich. That is because children are still growing. That is basic physiology," said Adam Drewnowski, director of the Nutritional Sciences Program at the University of Washington, who was not part of the study.
The findings may not be surprising, but they suggest that swapping out potato chips for cheese or vegetables then might help reduce the amount of calories kids eat at snack time, said Adam Brumberg, one of the authors of the study and the deputy director of the Food and Brand Laboratory at Cornell University.
"If you put into the rotation (healthier snacks) you can have a significant impact on weekly caloric intake," he suggested.
The study, which was funded in part by the cheese maker Bel Brands USA, involved 183 kids in 3rd through 6th grade.
Each of the kids was put in a room to watch TV and eat a snack - 45 kids were given potato chips, 36 were offered cheese, 59 were given raw vegetables and 43 were given cheese and vegetables.
After 45 minutes the researchers measured how much food the children had eaten.
They found that kids in the chip group ate by far the most calories - 620 on average.
Kids ate 200 calories of cheese, 60 calories of vegetables and 170 calories of the combination cheese-and-vegetables snack.
"Children tend to eat the foods they like - and one measure of preference is the amount eaten. So chips and cheese beat raw vegetables hands down. Why am I not surprised?" said Drewnowski in an email to Reuters Health.
The findings might be obvious, but they also reveal that kids felt full after eating fewer calories of the cheese and vegetables than after eating the potato chips.
"One thing that was crucial about this study is there was no restriction on the quantity. No one in the snacking conditions ate everything," said Brumberg.
In other words, the kids ate until they felt full, and for the potato chip group that meant eating a lot more calories than the cheese-and-veggies group.
To put those 600 potato chip calories into perspective, a moderately active eight-year-old boy should eat about 1400 to 1600 calories a day, according to the U.S. Department of Agriculture.
ROLE OF RESTRICTION?
Brumberg said there's a lot of conflicting information regarding nutrition and ways to get kids to eat healthy, but restricting kids' diets to only the healthiest of foods might not be the right approach.
"We think that for most people restrictions are setting up an opportunity for you to fail," he said.
For some families, restricting snacks to only the healthiest ones is not even possible.
Drewnowski pointed out that children from low income families are affected the most by obesity, and "red bell peppers at $3.99 per pound are not going to solve that problem."
Brumberg suggested that parents should still let kids have the foods they prefer, but limit them.
"The most effective way, we believe, is to put (healthy snacks) in the rotation. Don't take away everything that they love, but reduce calories over the week," he said.

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

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.

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Spending on food advertising to kids fell in '09 - U.S. FTC

WASHINGTON (Reuters) - Food companies spent considerably less to advertise to children in 2009 than they did in 2006 as they shifted to the Internet, and products pitched to kids got slightly healthier, the U.S. Federal Trade Commission said in a report on Friday.
Cereal makers, fast food restaurants and other food companies spent $1.79 billion to advertise to children aged 2 to 17 in 2009, down almost 20 percent, on an inflation-adjusted basis, from $2.1 billion three years earlier, the FTC said.
But that drop did not come necessarily because companies advertised less, but because they spent less on expensive television advertising and 50 percent more on cheaper online marketing, the FTC said.
Ninety percent of the 48 companies surveyed reported doing some online marketing, the FTC said. The agency did not identify the companies.
The FTC also found "modest nutritional improvements" in the foods advertised to children, in categories including cereals, drinks and fast-food kids' meals.
Cereals advertised to children had a small drop in sugar content and used more whole grains, while fast-food restaurants advertised fewer unhealthy products, the FTC said.
But beverages remained an issue since the FTC found that drinks marketed to children had an average of more than 20 grams of added sugar per serving. That is slightly less than a candy bar.
The FTC praised the Better Business Bureau's Children's Food and Beverage Advertising Initiative for making "major strides" in self-regulation, but urged more progress.
The CFBAI has nudged its members to improve foods advertised to children, and said that cereals in particular were better than those several years ago.
"This is an incremental process. As self-regulation has matured, it's gotten more robust but, yes, there's room for improvement," said CFBAI Director Elaine Kolish.
But health advocates have been unimpressed with the food industry's efforts to reduce fat, sugar and salt in foods.
"Companies still aren't doing nearly enough to support parents and protect kids," said Margo Wootan, director of nutrition policy for the Center for Science in the Public Interest.
She was particularly critical of industry's decision to allow companies to advertise popsicles and fruit roll-ups to children. "The overwhelming majority of marketing is for foods that will compromise children's health," she said.
The issue is a source of concern since about 17 percent of U.S. children and teens are obese and another 15 percent are overweight, according to 2010 data by the U.S. Centers for Disease Control and Prevention.
The Obama administration, with its goal of containing healthcare costs, has emphasized children's health. First Lady Michelle Obama's "Let's Move" campaign encourages children to eat healthier food and exercise more.
Several government agencies, including the FTC, lost a pitched battle last year to have the companies voluntarily end all advertising to children unless the food being promoted was healthy fare such as whole grains, fresh fruits or vegetables.

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Chelation doesn't help kids with autism: study

NEW YORK (Reuters Health) - Removing heavy metals from the body through a process traditionally used to treat mercury and lead poisoning doesn't help relieve autism symptoms, a new analysis suggests.
During chelation therapy, patients are given injections of a chemical that binds to heavy metals, lowering their concentration in the blood and ultimately allowing the metals to be excreted through urine.
Chelation gained traction as an alternative treatment for autism due to a theory that mercury poisoning might play a role in the developmental disorder. However, evidence hasn't supported that idea and it's been essentially discarded in the scientific community, researchers said.
The procedure also carries safety concerns, including risks of kidney damage and gastrointestinal problems.
Lead researcher Tonya Davis from Baylor University in Waco, Texas, said the study team's goal was not to tell parents which treatments they should or shouldn't seek for their children.
"I see that they want to try everything, and they are well intentioned," she told Reuters Health.
"But there are risks involved with any treatment choice, and some of those risks are very serious. So far science does not support (chelation) as being an effective treatment, and that's a big risk to take when you have limited resources and limited time."
The Centers for Disease Control and Prevention estimates that one in 88 kids in the U.S. has an autism spectrum disorder.
Davis and her colleagues found five studies that tested the effects of chelation in kids with autism. Those studies each had between one and 41 children, from age three to 14.
Researchers had given the kids chelation therapy - sometimes along with vitamin supplements or other treatments - between one and 12 times a week for up to seven months. They used tests and questionnaires or anecdotal reports from parents to see how symptoms changed over time.
The study with only one child, a four-year-old boy, found chelation had positive effects on autism symptoms based on a parent report. The other four studies all showed mixed results, with some kids improving on some symptom measures.
However, none of the studies provided any certainty that those benefits were due to chelation itself, and not another treatment or just kids getting older, the researchers wrote in the journal Research in Autism Spectrum Disorders.
Davis said she and her colleagues were surprised to find so few studies measuring the effects of chelation, given how many families they each knew that were using it. That lack of evidence was a concern, she said, along with the questionable study designs and conclusions.
"I just hope that parents get as much information as they can" before trying a new treatment, Davis said.
A typical package of chelation treatments runs for about $2,000 to $5,000. In addition to treating lead poisoning, chelation has also been used for cancer and heart disease.
But when it comes to autism, even calling chelation an alternative therapy is a stretch, said one autism researcher not involved in the new study.
"There's really no evidence that mercury causes autism or has a place in causing autism, and also we know that chelation can be dangerous as well. Even the underlying theories don't make sense," said Dr. Joyce Mauk, head of the Child Study Center, an organization that treats kids with developmental disabilities in Fort Worth, Texas.
"Most children with developmental disabilities, what gets them better is a really skilled therapist and lots of work," Mauk told Reuters Health.
"If you hear about something when all you do is inject something or take a pill, it's unlikely to work."
SOURCE: Research in Autism Spectrum Disorders, January 2013.

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Violence, fear & suspicion imperil Pakistan's war on polio

ISLAMABAD, Pakistan (Reuters) - Pakistani health worker Bushra Bibi spent eight years trekking to remote villages, carefully dripping polio vaccine into toddlers' pursed mouths to protect them from the crippling disease.
Now the 35-year-old mother is too scared to go to work after masked men on motorbikes gunned down nine of her fellow health workers in a string of attacks this week.
"I have seen so much pain in the eyes of mothers whose children have been infected. So I have never seen this as just a job. It is my passion," she said. "But I also have a family to look after ... Things have never been this bad."
After the deaths, the United Nations put its workers on lockdown. Immunizations by the Pakistani government continued in parts of the country. But the violence raised fresh questions over stability in the South Asian nation.
Pakistan's Taliban insurgency, convinced that the anti-polio drive is just another Western plot against Muslims, has long threatened action against anyone taking part in it.
The militant group's hostility deepened after it emerged that the CIA - with the help of a Pakistani doctor - had used a vaccination campaign to spy on Osama bin Laden's compound before he was killed by U.S. special forces in a Pakistan town last year.
Critics say the attacks on the health workers are a prime example of the government's failure to formulate a decisive policy on tackling militancy, despite pressure from key ally the United States, the source of billions of dollars in aid.
For years, authorities were aware that Taliban commanders had broadcast claims that the vaccination drive was actually a plot to sterilize Muslims.
That may seem absurd to the West, but in Pakistan such assertions are plausible to some. Years of secrecy during military dictatorships, frequent political upheaval during civilian rule and a poor public education system mean conspiracy theories run wild.
"Ever since they began to give these polio drops, children are reaching maturity a lot earlier, especially girls. Now 12 to 13-year-old girls are becoming women. This causes indecency in society," said 45-year-old Mir Alam Khan, a carpet seller in the northern town of Dera Ismail Khan.
The father of four didn't allow any of his children to receive vaccinations.
"Why doesn't the United States give free cures for other illnesses? Why only polio? There has to be an agenda," he said.
While health workers risk attacks by militants, growing suspicions from ordinary Pakistanis are lowering their morale. Fatima, a health worker in the northwestern city of Peshawar, said that reaction to news of the CIA polio campaign was so severe that many of her colleagues quit.
"People's attitudes have changed. You will not believe how even the most educated and well-to-do people will turn us away, calling us U.S. spies and un-Islamic," said the 25-year-old who did not give her last name for fear of reprisals.
"Boys call us names, they say we are 'indecent women'."
Pakistan's government has tried to shatter the myths that can undermine even the best-intentioned health projects by turning to moderate clerics and urging them to issue religious rulings supporting the anti-polio efforts.
Tahir Ashrafi, head of the All Pakistan Ulema Council, said the alliance of clerics had done its part, and it was up to the government to come to the rescue of aid workers.
"Clerics can only give fatwas and will continue to come together and condemn such acts," he said. "What good are fatwas if the government doesn't provide security?"
RISK OF POLIO RETURNING
That may be a tall order in Pakistan, where critics allege government officials are too busy lining their pockets or locked in power struggles to protect its citizens, even children vulnerable to diseases that can cripple or disfigure them.
Pakistani leaders deny such accusations.
Politicians also have a questionable track record when it comes to dealing with all the other troubles afflicting nuclear-armed Pakistan.
The villages where health workers once spent time tending to children often lack basic services, clinics, clean water and jobs. Industries that could strengthen the fragile economy are hobbled by chronic power cuts.
Deepening frustrations with those issues often encourage Pakistanis to give up on the state and join the Taliban.
So far it's unclear who is behind the shootings. The main Taliban spokesman said they were opposed to the vaccination scheme but the group distanced itself from the attacks.
But another Taliban spokesman in South Waziristan said their fighters were behind an attack on a polio team in the northwestern town of Lakki Marwat on Monday. "The vaccinations were part of "a secret Jewish-American agenda to poison Pakistanis", he said.
What is clear is the stakes are high.
Any gaps in the program endanger hard-won gains against a disease that can cause death or paralysis within hours.
A global effort costing billions of dollars eradicated polio from every country except Nigeria, Afghanistan and Pakistan.
Vaccinations cut Pakistan's polio cases from 20,000 in 1994 to 56 in 2012 and the disease seemed isolated in a pocket in the north. But polio is spread person-to-person, so any outbreak risks re-infecting communities cleared of the disease.
Last year, a strain from Pakistan spread northeast and caused the first outbreak in neighboring China since 1999.
Oliver Rosenbauer, a spokesman for the World Health Organization, said the group had been coming closer to eradicating the disease.
"For the first time, the virus had been geographically cornered," he said. "We don't want to lose the gains that had been made ... Any suspension of activities gives the virus a new foothold and the potential to come roaring back and paralyze more children."
MOURNING FAMILIES
Condemnation of the killings has been nearly universal. Clerics called for demonstrations to support health workers, the government has promised compensation for the deaths and police have vowed to provide more protection.
For women like Fehmida Shah, it's already too late. The 44-year-old health worker lived with her family in a two-room house before gunmen shot her on Tuesday.
Her husband, Syed Riaz Shah, said she spent her tiny salary - the equivalent of just $2 a day - on presents for their four daughters. Even though the family was struggling, she always found some spare money for any neighbor in need.
"She was very kind and big hearted. All the women in our lane knew her," he said.
"The entire neighborhood is in shock. Pray for my daughters. I will get through this. But I don't know how they will."

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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 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 say they believe the problem is under control, that control is hardly evident.
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 was part of the reason he left the testing industry to focus on anti-doping research.
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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.
___
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.
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.
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 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.
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.
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 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.
Oldenburg told the AP he was surprised at the scope of steroid use in college football, even in Colorado State's locker room. "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.
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. 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 love to eat."
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.
But looking solely at the most significant weight gainers also ignores players like Bryan Maneafaiga.
In the summer of 2004, Bryan 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 but not 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, 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 former coach, June Jones, said it was news to him that one of his players had used steroids. Jones, who now coaches at Southern Methodist University, believes the NCAA does a good job rooting out steroid use.
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 for sports.
In practice, though, the NCAA's roughly 11,000 annual tests amount to 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, experts like Catlin 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.
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.
Doping 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.
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.
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.
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.
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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.
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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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AP IMPACT: Big Pharma cashes in on HGH abuse

A federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies, an Associated Press investigation shows.
The crackdown, which began in 2006, reduced the illegal flow of unregulated supplies from China, India and Mexico.
But since then, Big Pharma has been satisfying the steady desires of U.S. users and abusers, including many who take the drug in the false hope of delaying the effects of aging.
From 2005 to 2011, inflation-adjusted sales of HGH were up 69 percent, according to an AP analysis of pharmaceutical company data collected by the research firm IMS Health. Sales of the average prescription drug rose just 12 percent in that same period.
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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 second of a two-part series.
___
Unlike other prescription drugs, HGH may be prescribed only for specific uses. U.S. sales are limited by law to treat a rare growth defect in children and a handful of uncommon conditions like short bowel syndrome or Prader-Willi syndrome, a congenital disease that causes reduced muscle tone and a lack of hormones in sex glands.
The AP analysis, supplemented by interviews with experts, shows too many sales and too many prescriptions for the number of people known to be suffering from those ailments. At least half of last year's sales likely went to patients not legally allowed to get the drug. And U.S. pharmacies processed nearly double the expected number of prescriptions.
Peddled as an elixir of life capable of turning middle-aged bodies into lean machines, HGH — a synthesized form of the growth hormone made naturally by the human pituitary gland — winds up in the eager hands of affluent, aging users who hope to slow or even reverse the aging process.
Experts say these folks don't need the drug, and may be harmed by it. The supposed fountain-of-youth medicine can cause enlargement of breast tissue, carpal tunnel syndrome and swelling of hands and feet. Ironically, it also can contribute to aging ailments like heart disease and Type 2 diabetes.
Others in the medical establishment also are taking a fat piece of the profits — doctors who fudge prescriptions, as well as pharmacists and distributors who are content to look the other way. HGH also is sold directly without prescriptions, as new-age snake oil, to patients at anti-aging clinics that operate more like automated drug mills.
Years of raids, sports scandals and media attention haven't stopped major drugmakers from selling a whopping $1.4 billion worth of HGH in the U.S. last year. That's more than industry-wide annual gross sales for penicillin or prescription allergy medicine. Anti-aging HGH regimens vary greatly, with a yearly cost typically ranging from $6,000 to $12,000 for three to six self-injections per week.
Across the U.S., the medication is often dispensed through prescriptions based on improper diagnoses, carefully crafted to exploit wiggle room in the law restricting use of HGH, the AP found.
HGH is often promoted on the Internet with the same kind of before-and-after photos found in miracle diet ads, along with wildly hyped claims of rapid muscle growth, loss of fat, greater vigor, and other exaggerated benefits to adults far beyond their physical prime. Sales also are driven by the personal endorsement of celebrities such as actress Suzanne Somers.
Pharmacies that once risked prosecution for using unauthorized, foreign HGH — improperly labeled as raw pharmaceutical ingredients and smuggled across the border — now simply dispense name brands, often for the same banned uses. And usually with impunity.
Eight companies have been granted permission to market HGH by the U.S. Food and Drug Administration, which reviews the benefits and risks of new drug products. By contrast, three companies are approved for the diabetes drug insulin.
The No. 1 maker, Roche subsidiary Genentech, had nearly $400 million in HGH sales in the U.S. last year, up an inflation-adjusted two-thirds from 2005. Pfizer and Eli Lilly were second and third with $300 million and $220 million in sales, respectively, according to IMS Health. Pfizer now gets more revenue from its HGH brand, Genotropin, than from Zoloft, its well-known depression medicine that lost patent protection.
On their face, the numbers make no sense to the recognized hormone doctors known as endocrinologists who provide legitimate HGH treatment to a small number of patients.
Endocrinologists estimate there are fewer than 45,000 U.S. patients who might legitimately take HGH. They would be expected to use roughly 180,000 prescriptions or refills each year, given that typical patients get three months' worth of HGH at a time, according to doctors and distributors.
Yet U.S. pharmacies last year supplied almost twice that much HGH — 340,000 orders — according to AP's analysis of IMS Health data.
While doctors say more than 90 percent of legitimate patients are children with stunted growth, 40 percent of 442 U.S. side-effect cases tied to HGH over the last year involved people age 18 or older, according to an AP analysis of FDA data. The average adult's age in those cases was 53, far beyond the prime age for sports. The oldest patients were in their 80s.
Some of these medical records even give explicit hints of use to combat aging, justifying treatment with reasons like fatigue, bone thinning and "off-label," which means treatment of an unapproved condition. In other cases, the drug was used "for an unknown indication," meaning that the reason for treatment wasn't clear.
Even Medicare, the government health program for older Americans, allowed 22,169 HGH prescriptions in 2010, a five-year increase of 78 percent, according to data released by the Centers for Medicare and Medicaid Services in response to an AP public records request. And nearly half the increase came in one year: 2007.
"There's no question: a lot gets out," said hormone specialist Dr. Mark Molitch of Northwestern University, who helped write medical standards meant to limit HGH treatment to legitimate patients.
And those figures don't include HGH sold directly by doctors without prescriptions at scores of anti-aging medical practices and clinics around the country. Those numbers could only be tallied by drug makers, who have declined to say how many patients they supply and for what conditions.
The AP approached every U.S.-authorized manufacturer to ask what efforts they make to market responsibly and prevent abuse. Only one HGH supplier, Novo Nordisk, agreed to an interview.
"We're doing our level best to make sure that the right patients are getting the right medicine at the right time," said company spokesman Ken Inchausti.
He said the company is aware of the abuse issue. He said if patients apply for assistance from the company's patient-support hub, prescriptions will be flagged for review if they are missing the most rigorous test or an endocrinologist's signature. He said the company won't sell HGH directly to doctors accused of bad practices and does not deal with anti-aging clinics.
Representatives of other FDA-approved HGH makers insist they do not encourage use by bodybuilders or athletes or wealthy baby boomers trying to recapture their youth. But some said they are largely powerless to control who uses their medications or why.
"Lilly cannot restrict the actions of distributors, pharmacies or doctors," Eli Lilly spokeswoman Kelley Murphy said in a written statement.
That argument doesn't fly for critics like Dr. Peter Rost, a retired Pfizer executive who filed a whistleblower lawsuit over the HGH marketing practices of Pharmacia, which later merged with Pfizer. He said drug companies are simply looking the other way and betting that their profits will eclipse the cost of any fines.
They view it as "good business," he said.
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PEDDLED ON INTERNET
Type "human growth hormone" into any Internet search engine, and it will spit back countless websites with overblown promises of smoother skin, better sex, weight loss and even renewed body organs.
Any doctor who actually prescribes the drug for those purposes is taking a legal risk.
FDA regulations ban the sale of HGH as an anti-aging drug. In fact, since 1990, prescribing it for things like weight loss and strength conditioning has been punishable by 5 to 10 years in prison.
Such marketing claims are routinely made at hormone clinics like Palm Beach Life Extension, whose owners are among 13 people now awaiting trial on federal charges in Florida in a steroids and HGH distribution case brought last year.
"Grow YOUNG with Us!" screamed a banner on the company's now-defunct website, which advertised that HGH can reduce body fat, improve vision, strengthen the immune system, aid kidney function, lower blood pressure and enhance memory and mood.
The clinic arranged to have its clients' prescriptions filled at Treasure Coast Pharmacy, in Jensen Beach, Fla.
In 2009, the FBI recorded a phone call between the pharmacy's owner, Peter Del Toro, and a doctor in Elkton, Md., who was cooperating with agents after being implicated in a related steroid-distribution case.
Their talk, documented in a court filing, illustrates how things often work in the networks of pharmacies and clinics that drive HGH sales.
Patients submitted a medical history form by mail and took a blood test. But in most instances, the indictment said, the evaluation was a sham: One doctor was charged with giving a clinic a pad of blank, signed prescriptions to save him the chore of signing off on each diagnosis. He got $50 for every drug order bearing his name, the indictment said.
Dr. Rodney Baltazar, the Maryland physician cooperating with the FBI, sometimes consulted briefly with patients via webcam. But he made it clear in the call that those evaluations were perfunctory at best.
Baltazar was a gynecologist, not an endocrinologist. He said he knew "a little bit" about HGH and testosterone, which are often prescribed in tandem, but he relied largely on clinic salespeople to set doses.
The pharmacist coached the doctor: Keep detailed medical charts documenting that patients are taking the drug for at least some kind of health problem, just in case the U.S. Drug Enforcement Administration ever came calling.
"Because somebody questions you, you want to be able to say, 'Here, look at his chart. You know, he's got fatigue. He's got, you know, a decreased sex drive. He's got increased body fat. He has some -- some slight depression, probably.' Whatever his signs and symptoms are."
None of these conditions is a legal reason to prescribe HGH. But the pharmacist said that most investigators will be satisfied and move on "because there's guys that are just selling stuff basically like a boiler room."
Del Toro was arrested along with 12 other people in September 2011 on charges that they distributed steroids and human growth hormone to people who had no legitimate medical need. He is awaiting trial. His lawyer declined to comment. Baltazar was sentenced to six months in prison for involvement in steroid distribution schemes.
At the height of the crackdown in 2007, the federal government went after Pfizer in a case involving anti-aging clinics. The company paid $34.7 million in fines to settle the case — 11 percent of the company's annual revenue from the drug.
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TROUBLED HISTORY
Blockbuster U.S. sales of HGH represent the latest frustration in 25 years of government efforts to control abuse of the growth drug made infamous by sports scandals.
First marketed in 1985 for children with stunted growth, HGH was soon misappropriated by adults intent on exploiting its modest muscle- and bone-building qualities. Congress limited HGH distribution to the handful of rare conditions in an extraordinary 1990 law, overriding the generally unrestricted right of doctors to prescribe medicines as they see fit.
Despite the law, illicit HGH spread around the sports world in the 1990s, making deep inroads into bodybuilding, college athletics, and professional leagues from baseball to cycling. The even larger banned market among older adults has flourished more recently.
For years, cheaper supplies from unauthorized foreign factories, particularly in China, fed the market via direct and Internet sales that sidestepped the medical establishment.
Though such shipments were banned under other law, the imports initially attracted little attention because they were usually labeled as raw pharmaceutical ingredients, which compounding pharmacies are allowed to bring into the country.
That flow began to be curtailed in 2006, when U.S. drug authorities stepped up efforts to block shipments at the border.
A handful of pharmacies across the country were hit with criminal charges over their handling of HGH. Federal prosecutors charged China's biggest HGH maker, GeneScience Pharmaceutical, with illegally distributing its Jintropin brand in the U.S. The company's CEO pleaded guilty in 2010.
With illicit supplies crimped, many pharmacies stopped selling unauthorized HGH. But tens of thousands of adult abusers began buying pricey U.S.-approved HGH that remained available in abundant supply, the AP found in its analysis of sales data.
Thus, pushed by a powerful demand, sales of U.S.-approved brands have swelled far beyond expected levels for a drug approved in just a handful of rare conditions.
Dr. Robert Marcus, a retired hormone specialist who left HGH manufacturer Eli Lilly and Co. in 2008, said that company was bent on stopping foreign counterfeits, not on cutting off abusers. "That's where their major level of frustration was — pharmaceutical fraud — rather than focusing on people who were using growth hormone illegitimately," he said.
Dr. Jim Meehan, of Tulsa, Okla., who has used HGH to treat aging problems and sports injuries, said the federal clampdown "never seemed to affect my patients and their ability to get Omnitrope, Tev-Tropin" and other government-approved brands.
The big drug companies have applauded the foreign crackdown and urged the government to do even more to combat sales of fake or fraudulently labeled HGH. In 2004, Bruce Kuhlik, speaking for the Pharmaceutical Research and Manufacturers of America, told a federal task force that unauthorized drug importation "is inherently unsafe" and industry representatives used Chinese HGH imports as their poster child.
In 2007, as the HGH embargo gained momentum, authorized makers picked up 41 percent more HGH orders, raising their annual total from 245,000 to 345,000, according to the analysis of the IMS Health data. Similarly, most of the drug's sales boom happened in the first two years of the crackdown, with 46 percent inflation-adjusted growth in yearly sales to $1.1 billion.
Steve Kleppe, of Scottsdale, Ariz., a restaurant entrepreneur who has taken HGH for almost 15 years to keep feeling young, said he noticed a price jump of about 25 percent after the block on imports. He now buys HGH directly from a doctor at an annual cost of about $8,000 for himself and the same amount for his wife.
Despite higher prices, the business has expanded in recent years largely on the strength of sales to healthy adults who can afford to indulge their hope of retaining youthful vigor.
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GROWING OLD
Many older patients go for HGH treatment to scores of anti-aging practices and clinics heavily concentrated in retirement states like Florida, Nevada, Arizona and California.
These sites are affiliated with hundreds of doctors who are rarely endocrinologists. Instead, many tout certification by the American Board of Anti-Aging and Regenerative Medicine, though the medical establishment does not recognize the group's bona fides.
The clinics offer personalized programs of "age management" to business executives, affluent retirees, and other patients of means, sometimes coupled with the amenities of a vacation resort.
The clinics insist there are few, if any, side effects from HGH. Mainstream medical authorities say otherwise.
A 2007 review of 31 medical studies showed swelling in half of HGH patients, with joint pain or diabetes in more than a fifth. A French study of about 7,000 people who took HGH as children found a 30 percent higher risk of death from causes like bone tumors and stroke, stirring a health advisory from U.S. authorities.
For proof that the drug works, marketers turn to images like the memorable one of pot-bellied septuagenarian Dr. Jeffry Life, supposedly transformed into a ripped hulk of himself by his own program available at the upscale Las Vegas-based Cenegenics Elite Health. (He declined to be interviewed.)
These promoters of HGH say there is a connection between the drop-off in growth hormone levels through adulthood and the physical decline that begins in late middle age. Replace the hormone, they say, and the aging process slows.
"It's an easy ruse. People equate hormones with youth," said Dr. Tom Perls, a leading industry critic who does aging research at Boston University. "It's a marketing dream come true."
Some scientific studies of HGH have found modest benefits: some muscle and bone building, as well as limited fat loss, but nothing like the claims of the anti-aging industry. And some of the value credited to HGH may instead come from testosterone, which is routinely provided with HGH by anti-aging doctors and sports suppliers.
Endocrinologists say it's natural for the body to produce less growth hormone as people age beyond their early 20s, because they aren't growing anymore. Only a tiny number of adults with extraordinarily low HGH levels — perhaps several thousand of them — are believed to suffer real deficiencies that can properly be treated with the hormone.
Still, anti-aging doctors routinely diagnose otherwise healthy middle-aged people with an HGH deficiency, simply because their levels are lower than in young adults. "Basically anyone going through midlife," can benefit from the drug, declared one prescriber, Dr. Howard Elkin, of Whittier, Calif., who has himself competed as a bodybuilder.
Dr. Kenneth Knott, of Marietta, Ga., said HGH helps his older patients feel "more vibrant" and look "more alive."
Like many anti-aging doctors, he diagnoses patients by testing for a blood component called insulin growth factor, which is indirectly tied to HGH. Endocrinologists use a more authoritative test that stimulates the pituitary gland to make HGH itself. Nearly all insurers insist on this stimulation testing, and that's why clinic patients almost always pay for HGH out of their own pockets.
Bob Vitols, a 50-year-old lab assistant at a veterinary medicine company in Lincoln, Neb., is a rare exception. His unusually generous health plan isn't allowed to challenge a doctor's prescription.
Four years ago, Vitols began feeling run down. So he Googled his symptoms on the Internet, decided he had a hormone deficiency, and sought out a clinic.
One doctor put him on testosterone replacement therapy. A second clinic added HGH after diagnosing him with osteopenia, a mild bone thinning common in aging adults. It is not, however, a condition that can properly be treated with HGH.
Despite the diagnosis, the treatments — which can cost $10,000 per year — have been covered by his health insurance, he said. He takes Genotropin, the HGH made by Pfizer. His prescriptions are filled via mail order by CVS Caremark Corp., one of the largest dispensers of prescription drugs in the U.S.
Vitols said the drug changed his life: his mood is better, and he isn't burning out every day at 2 p.m. "I feel like I could walk outside and just walk through a fence — and come out fine on the other side," he said.
His experiences with the drug haven't all been positive, though. Vitols said he initially developed elevated liver enzymes and went to a specialist, who told him to stop taking hormones immediately.
Instead, Vitols said, he adjusted his dosage, and the problem disappeared.
He also dumped the specialist:
"I could tell he was against hormones right at the start," Vitols said.
___
Associated Press Writer David Caruso reported from New York and AP National Writer Jeff Donn reported from Plymouth, Mass. AP Writer Troy Thibodeaux provided data analysis assistance from New Orleans.
___
AP's interactive on the HGH investigation: http://hosted.ap.org/interactives/2012/hgh
___
The AP National Investigative Team can be reached at investigate(at)ap.org
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 second of a two-part series.

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Women’s Excellence in Endometriosis Presents a New State-of-the-Art Center for Pelvic Pain, Painful Intercourse, and Painful Periods in Lake Orion, MI

Pelvic pain, painful intercourse, and painful periods are all common symptoms of disabling disease in women called “endometriosis”. Women’s Excellence in Endometriosis has opened a unique center to help women dealing with this chronic painful condition.

Lake Orion, MI (PRWEB) December 21, 2012
Endometriosis is a disease affecting the female reproductive tract in which the endometrial lining of the uterus spreads into the pelvic cavity, implanting itself on the pelvic structures causing inflammation and pain. Symptoms of endometriosis include painful menstrual periods (dysmenorrhea) which cannot be relieved with typical over-the-counter pain medications such as acetaminophen or ibuprofen, irregular periods, pelvic pain, or difficulty conceiving a pregnancy. Untreated, endometriosis can lead to chronic pelvic pain (CPP), infertility, and disability in women.
Women’s Excellence in Endometriosis was designed to treat women with this chronic condition in a multidisciplinary fashion. Dr. Jonathan Zaidan has established himself as an expert in diagnosing and treating endometriosis. Dr. Zaidan is trained and credentialed in minimally invasive robotic surgery to treat endometriosis. Working primarily out of McLaren Oakland hospital in Pontiac, MI, Dr. Zaidan can remove most and sometimes all disease through this procedure. According to Dr. Zaidan, “Robotic resection of endometriosis is the most advanced treatment for the disease and can even provide a surgical cure for some individuals. The procedure is minimally invasive, which means no large incisions, patient goes home the same day, and recovery is much easier.”
According to Debbie Henry, NP-C, nurse practitioner at Women’s Excellence in Endometriosis, “Once diagnosis has been confirmed via laparoscopy, typically we start the patient on a six-month regimen of Lupron or Zoladex therapy, to help the body’s natural immune system clear as much of the endometriosis as possible, before going back into surgery for the robotic resection. We have found this protocol to be highly successful for most patients.” After the robotic resection procedure, hormonal control of estrogen is achieved through birth control options such as Depo Provera or a combined oral contraceptive. Hormonal suppression of estrogen retards a resurgence of the disease and allows for a longer lasting treatment.
“Women with endometriosis are dealing with a chronic illness and need specialized care. We just felt that we could not give these patients adequate time and the quality of care that they really needed in a busy OB/GYN setting, sandwiched between routine OB visits and annual exams,” states Zaidan. “We provide an inviting, calming atmosphere here at Women's Excellence in Endometriosis; our patients are dealing with a stressful, chronic condition and the last thing they need is a long wait or an impersonal quick visit. We are able to provide longer patient visits at this center. Our patients really become like family to us,” Henry offered.
Founded by Dr. Jonathan Zaidan, Women's Excellence in Endometriosis is a comprehensive center for women that have either been diagnosed with endometriosis or have the symptoms of endometriosis. Women’s Excellence in Endometriosis utilizes the latest and best treatment protocols to effectively treat the symptoms and sequelae of endometriosis. Whether a woman has known endometriosis or seeking a diagnosis for symptoms of painful intercourse, painful periods, chronic pelvic pain or irregular bleeding, Women's Excellence in Endometriosis is designed to diagnose, treat and improve the symptoms of endometriosis and chronic pelvic pain (CPP). Women’s Excellence in Endometriosis treats all women with these symptoms including those women in the teenage years, women who are desiring having a child, as well as women who are done with their childbearing. The knowledgeable, well trained, compassionate physicians and healthcare providers of Women’s Excellence in Endometriosis are now accepting new patients. Call for an appointment today

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US Drug Watchdog Urges Victims Of A Transvaginal Mesh Product Failure To Call them For The Names Of The Best Possible Women Attorneys-During The Holidays

The US Drug Watchdog intends to stay open everyday during the holidays in the hopes of helping victims of a transvaginal mesh, tape, or bladder sling failure get to the best possible attorneys, and for obvious reasons the attorneys will all be women. For more information please call the US Drug Watchdog at 866-714-6466. http://USDrugWatchdog.Com

(PRWEB) December 21, 2012
The US Drug Watchdog will stay open during the holidays, in the hopes of helping victims of a tranvaginal mesh, tape, or bladder sling failure get to the best possible attorneys. Because the damages are so gender specific, the group is promising the attorneys will all be women. The US Drug Watchdog is saying, "These tranvaginal mesh, tape, or bladder sling failures are the most complex, and devastating medical device failures we have ever heard of. The US FDA is now saying transvaginal mesh failures are causing complications in patients such as erosion and infection. Women who experience transvaginal mesh failure may need to have numerous corrective surgeries." The US Drug Watchdog intends to dramatically expand their transvaginal mesh product failure victims effort in 2013, and they will remain open during this holiday season with the hope of helping as many victims as possible get the contact information for the best possible attorneys, who are also women. For more information women, who are victims of a transvaginal mesh product failure are welcome to contact the US Drug Watchdog anytime at 866-714-6466. http://USDrugWatchdog.Com
The US Drug Watchdog is indicating symptoms of a transvaginal mesh, tape, or bladder sling implant failure may include:

Mesh erosion through the vagina (the mesh is protruding out of the vaginal wall)
Vaginal bleeding
Vaginal Infection
Urinary problems
Organ perforation
Hardening of the vaginal mesh
Injury to nearby organs
Severe Pelvic Pain
The US Drug Watchdog says, "One of the biggest problems we have with respect to our failed medical device or recalled drug initiative work is the average US consumer never hears about a drug recall or failures involving medical devices like a transvaginal mesh product failure. If you have a friend, or loved one who is a recipient of a transvaginal mesh, tape, or bladder sling device that has already failed, or is showing symptoms of a failure, please have them call us at 866-714-6466. We want to make certain all women, who are transvaginal mesh, tape, or bladder sling failure victims get to the best possible attorneys, to ensure they get the best possible compensation for their ordeal, and we will do our absolute best to make certain all of the attorneys are women.

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Study: Solo stars at higher death risk than bands

LONDON (AP) — Rock 'n' roll will never die — but it's a hazardous occupation.
An academic study published Thursday confirms that rock and pop musicians are more likely to die prematurely than the general population, and finds that solo artists are twice as likely to die young as members of bands.
Researchers from Liverpool John Moores University and Britain's Health Department studied 1,489 rock, pop, punk, R&B, rap, electronica and New Age stars who became famous between 1956 and 2006 — from Elvis Presley to the Arctic Monkeys.
They found that 137 of the stars, or 9.2 percent, had died, representing "higher levels of mortality than demographically matched individuals in the general population."
The researchers dismissed the "fanciful but unsubstantiated" popular myth that rock stars tend to die at 27 — as Jim Morrison, Jimi Hendrix, Janis Joplin, Kurt Cobain and Amy Winehouse all did. The average age of death was 45.2 years for North American stars and 39.6 for European ones.
Solo performers had twice the death risk of members of bands. Lead researcher Mark Bellis speculated that could be because bands provide peer support at stressful times.
"Solo artists, even though they have huge followings, may be relatively isolated," said Bellis, director of the Center for Public Health at Liverpool John Moores University.
Music critic John Aizlewood agreed that solo artists receive more attention and adulation — and also more pressure.
"And when you are a solo act, irrespective of what they say in interviews, it's an incredibly egotistical thing," he said. "So you tend to be dealing with people who are more emotionally extreme.
"They have an ego in the way a drummer or even a lead guitarist in a band doesn't."
In good news for aging rockers, the study found that, after 25 years of fame, stars' death rates began to return to normal — at least in Europe. A European star still living 36 years after achieving fame faces a similar mortality rate to the European public. But U.S. artists continue to die in greater numbers.
Bellis said factors contributing to the difference could include longer careers — and thus longer exposure to rock 'n' roll excess — in the U.S., a huge, populous country with greater opportunities for aging stars to stay on the road. Europe's stronger social safety net and socialized medicine may also play a role, he said.
The research, which updates a 2007 study by the same team, was published in the online journal BMJ Open.
The study suggests the infamous rock 'n' roll lifestyle may not be entirely to blame for rock stars' death risk.
The researchers looked for the first time at the role of "adverse childhood experiences" — such as physical or sexual abuse — on stars' later behavior.
They found that performers who had had at least one adverse childhood experience were more likely to die from drug and alcohol use or "risk-related causes."
"Substance abuse and risk-taking in stars are largely discussed in terms of hedonism, music industry culture, responses to the pressures of fame or even part of the creative process," the researchers said.
However, they said, "adverse experiences in early life may leave some predisposed to health-damaging behaviors, with fame and extreme wealth providing greater opportunities to engage in risk-taking."
But Ellis Cashmore, a cultural studies professor at Staffordshire University and author of the book "Celebrity/Culture," said it would be wrong to overlook "artistic frustration" as a factor in artistic self-destruction.
He said troubled artists from Vincent Van Gogh and Ernest Hemingway to the Beach Boys' Brian Wilson all illustrate "the torment that creativity brings with it."
"Perhaps it is the continual striving for some sort of unattainable artistic perfection that drives them," he said.

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Lilly tests therapy to rid brain plaques in mice with Alzheimer's

(Reuters) - Drugmaker Eli Lilly  & Co said it may have found a way to remove plaque from the brains of forgetful, old mice using an experimental therapy it hopes someday will be used to treat Alzheimer's disease in humans.

Previous animal studies have demonstrated that it is possible to prevent the formation of brain plaques, which are thought to be a hallmark of the progressive memory-robbing disease. But until now, researchers have not been able to remove pre-existing plaques, made of amyloid beta protein, once they have deposited into the brain, Lilly said.

These deposited plaques are insoluble, whereas soluble forms of amyloid beta are free-floating around the brain and have been easier to target.

Lilly researchers developed a genetically engineered antibody that selectively targets insoluble plaques and was able to cross the blood-brain barrier. The antibody was then able to bind itself to the deposited amyloid beta, and clear roughly 50 percent of pre-existing plaques in the mice without causing damage to tiny vessels in the brain.

"We're very enthused about understanding the mechanism and science behind it," lead researcher Ronald DeMattos said in a telephone interview. "We don't know how it translates in humans until we test human antibodies in clinical trials."

Indeed, there have been scores of mice that were cured of cancer and other diseases with experimental drugs that did not work in humans.

But Lilly is excited about this study because, at least in mice, a new therapeutic approach for Alzheimer's disease appears to be viable.

DeMattos said the drugmaker, which is developing other Alzheimer's drugs, is already engineering a human antibody that will target insoluble plaques. He said he expects the company to begin clinical trials using this antibody within a year.

Results of the study, entirely funded by Lilly, were published in the journal Neuron on Wednesday.

Lilly's best known Alzheimer's disease drug is solanezumab, a medicine given by infusion that attacks amyloid beta protein. In data presented in August, the drug failed in large clinical trials to arrest cognitive and physical declines among patients with mild to moderate Alzheimer's. But it was shown to somewhat delay cognitive declines in patients with mild symptoms.

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U.S. House Democrats introduce new meningitis legislation

WASHINGTON (Reuters) - Two Democratic lawmakers in the U.S. House of Representatives introduced legislation on Wednesday aimed at bolstering federal oversight of compounded drugs like the tainted steroid injections blamed for a deadly fungal meningitis outbreak.

But the legislation is not likely to move forward in the Republican-controlled chamber. In fact, aides from both parties said neither the House nor the Democratic-led Senate is expected to vote on meningitis legislation this year, given the little time remaining and the overarching focus on so-called "fiscal cliff" deficit-reduction talks.

Some Democratic lawmakers have warned that enacting tighter federal standards for compounded drugs could become more difficult in the new year, as the meningitis outbreak wanes and loses public attention.

The outbreak, linked to steroid injections from the Massachusetts-based New England Compounding Center, has sickened 541 people, 36 of whom have died, according to the U.S. Centers for Disease Control and Prevention.

The public health disaster has also spawned several investigations including a U.S. grand jury probe.

Drug compounding is a traditional pharmacy practice in which pharmacists alter or recombine drugs to meet the special needs of individual patients with a physician's prescription. The practice is regulated mainly by state pharmacy boards that do not impose the stringent safety and efficacy standards that the Food and Drug Administration requires of drug manufacturers.

But in the past few decades, some compounding pharmacies, such as NECC, have become large operations selling thousands of drug doses to clinics, hospitals and other healthcare providers across state lines.

Critics say those operations rival drug manufacturers in scale and should be subjected to strict FDA standards. But past attempts to strengthen federal regulation has been defeated by industry lobbying and legal maneuvering.

FDA has lately come under fire in Congress, mainly from Republican lawmakers who say it has the authority to act against problem compounders but failed to take effective action against NECC despite problems dating back ten years.

Public Citizen, an advocacy group that tracks drug safety issues, has called for an investigation of FDA's failures and urged the agency to inspect other compounders where problems have also surfaced over the past several years.

The legislation introduced on Wednesday by Democratic representatives Rosa DeLauro of Connecticut and Nita Lowery of New York is the second House Democratic measure to emerge since the outbreak first surfaced in mid-September.

The bill, known as the SAFE Compounding Drugs Act, would require compounding companies to register with the FDA, allow the agency to set minimum production standards and impose new labeling restrictions on compounded drugs.

Representative Ed Markey, a Democrat from Massachusetts, also introduced a measure to address FDA's authority last month.

The agency itself has called on Congress to allow it to set national standards for large drug compounding operations. FDA officials are scheduled to discuss a potential new regulatory structure during a meeting with state officials on December 19.

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Pfizer breast cancer drug delays progression 18 months

(Reuters) - An experimental drug showed impressive effectiveness and safety in a mid-stage trial against a common form of advanced breast cancer, lifting Pfizer Inc shares nearly 2 percent.

The favorable results prompted the drugmaker to plan large late-stage trials of the drug next year. If approved, the medicine could fetch multi-billion dollar sales, industry analysts said.

The drug, called PD-0332991, delayed by more than 18 months the worsening of symptoms for postmenopausal women with the most common form of breast cancer. Data from the study of the drug was presented on Wednesday at the annual San Antonio Breast Cancer Symposium.

The medicine, which blocks enzymes known as CDK4 and 6 kinases, was taken in combination with a standard drug called letrozole among women who were estrogen receptor positive - meaning tumors grow in response to estrogen - and HER2-negative, meaning that the HER2 protein is not causing the cancer. Such patients make up about 60 percent of breast cancer cases.

Patients had either locally advanced tumors or cancer that had spread to other parts of the body.

Those taking both drugs went an average of 26.1 months before tumors worsened. That compared with 7.5 months for those taking letrozole, but not PD-0332991. The 18.6 month difference was considered statistically significant.

"In a disease where a several-month improvement in progression-free survival is considered impressive, we view an 18.6-month improvement in PFS as remarkable," said analyst Jon LeCroy of MKM Partners. He predicted Pfizer will introduce the medicine in 2017.

Letrozole is the chemical name of Femara, a Novartis drug that belongs to a class of treatments called aromatase inhibitors that block production of estrogen.

Side effects seen in patients taking the drug combination included anemia, fatigue and neutropenia - a decline in white blood cells called neutrophils that can put patients at higher risk of infection.

"If approved in a front-line breast cancer setting, this drug has the potential to generate $2 billion to $6 billion" in worldwide sales for these types of breast cancer patients, said Mark Schoenebaum, an analyst with ISI Group, of PD-0332991.

Schoenebaum, who had not previously predicted any revenue for the drug, said the medicine could provide considerable "upside" to Pfizer revenue if it is cleared by regulators.

He noted that researchers have not yet disclosed to what degree the Pfizer drug might have prolonged patient survival.

Pfizer had released some data from the trial in May, but released updated findings on Wednesday.

Shares of Pfizer closed up 46 cents, or 1.8 percent, at $25.64 on the New York Stock Exchange on Wednesday.

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Dueling Fiscal Cliff Deceptions

A fog of misinformation has settled on the fiscal cliff, as both House Speaker John Boehner and Treasury Secretary Timothy Geithner have traded conflicting, misleading and false statements in recent days on the president’s deficit-reduction plan:

    * Geithner falsely claimed on “Fox News Sunday” that the president’s proposals to slow Medicare growth are “not shifting costs to seniors.” There are four proposals that would increase costs to some seniors by $32.9 billion over 10 years, beginning in 2017, including higher premiums and new fees and surcharges.
    * Boehner, also on Fox News, wrongly stated that the administration has proposed “$400 billion worth of unspecified cuts.” The administration has itemized nearly $600 billion worth of what it calls “cuts and reforms to mandatory programs” — half of that from Medicare.
    * Geithner exaggerates when he says the ratio of spending cuts to tax increases is “roughly 2 to 1.” The administration’s $3 trillion in “spending cuts” includes more than $800 billion on two wars financed by deficit spending and already set to end, and tens of billions in new or higher fees and surcharges described as “reforms.”
    * Boehner and other GOP leaders claimed in a letter to Obama that the president’s “proposal calls for $1.6 trillion in new tax revenue, twice the amount you supported during the campaign.” But the fact is that Obama’s fiscal 2013 budget proposal calls for $1.6 trillion in new tax revenues — which his opponent, Mitt Romney, attacked during the campaign.
    * Boehner repeatedly (and falsely) says the president’s fiscal 2013 budget plan will create “trillion-dollar deficits for as far as the eye can see.” It’s true the fiscal 2013 deficit is projected to be close to $1 trillion, but annual deficits would fall each year thereafter — dropping to $488 billion by Obama’s final year in 2017.

There is also much confusion on what exactly is in the president’s plan — despite Geithner’s briefing to Republican leaders and their staffs on Nov. 29.

Boehner says the administration has proposed more in new stimulus spending than it proposes in spending cuts. His office says the new stimulus spending could exceed $600 billion but the president proposes only $400 billion in spending cuts. The administration tells us that the stimulus package would not exceed $200 billion.

Obama’s Plan: Neither Painless nor Lacking Specifics

Geithner and Boehner have been the point men for their respective sides of the fiscal cliff debate.

Geithner briefed Republican leaders on Nov. 29 and made multiple TV appearances on Dec. 2 to talk about the president’s plan — which we detail in our Nov. 30 article, “Facing Facts on Fiscal Cliff.”

Geithner and Boehner both appeared on “Fox News Sunday” and each provided misleading information about the Obama administration’s proposed plan.

Geithner claimed that the president’s deficit reduction plan is about “strengthening Medicare, not shifting costs to seniors.” However, the president’s plan does shift some costs to seniors — mostly to higher-income beneficiaries, but also for all new beneficiaries.

There are four proposals, contained in both the president’s 2011 deficit-reduction plan and his fiscal 2013 budget, that would increase costs to seniors by $32.9 billion over 10 years. All four proposals would begin in 2017 — after Obama leaves office:

    * Expanded means testing for Medicare Parts B and D Premiums. The administration proposes to increase premiums under Medicare Part B (medical insurance) and D (prescription drugs) for higher-income seniors by 15 percent and freeze the high-income thresholds at current levels “until 25 percent of beneficiaries under parts B and D are subject to these premiums.” In 2012, only 5.1 percent of Part B enrollees and 3 percent of Part D enrollees pay higher premiums based on income, according to the Kaiser Family Foundation. The current thresholds for higher premiums are $85,000 for individuals and $170,000 for couples. Kaiser estimates that the income thresholds for paying higher premiums by 2035 will be equivalent to about $47,000 for individuals and $94,000 for couples “in today’s adjusted inflation dollars.” Cost to seniors: $28 billion over 10 years (pages 34-35).
    * Increased Medicare Part B deductible for new beneficiaries. The administration would increase the deductibles paid by new beneficiaries by $25 in 2017, 2019 and 2021. Cost to seniors: $2 billion over 10 years (page 35).
    * A copay for Medicare home-health care for new beneficiaries. There’s currently no copay. This proposal would create a new copay of $100 for each “home health episode.” Cost to seniors: $350 million over 10 years (page 35).
    * Medicare Part B premium surcharge for new beneficiaries who purchase Medigap coverage. The administration would impose a Part B premium surcharge for new beneficiaries who purchase “near first-dollar Medigap coverage.” Medigap policies cover Medicare’s out-of-pocket expenses, such as copays and deductibles. The administration’s plan says Medigap provides “less incentive” to make cost-efficient health care decisions. Cost to seniors: $2.5 billion over 10 years (page 35).

As he made the rounds of the other Sunday talk shows, Geithner gave an accurate — but incomplete — accounting of the president’s Medicare proposals. On “Meet the Press,” for example, Geithner said that “we’re proposing to modestly increase premiums for high income beneficiaries of Medicare.” But he did not mention that the president’s plan also raises costs for all new beneficiaries, not just those with high incomes.

For his part, Boehner twice criticized the administration for failing to provide detailed cuts, claiming the administration “put $400 billion worth of unspecified cuts that they’d be willing to talk about.” Geithner said that’s not true, claiming the administration has “proposed $600 billion of detailed reforms and savings, to our health care and other government programs.”

Boehner is wrong.

The president’s deficit-reduction plan, as proposed to Congress in September 2011, itemizes “nearly $580 billion in cuts and reforms to mandatory programs, of which $320 billion is savings from Federal health programs such as Medicare and Medicaid.” Those proposals are also listed in the president’s fiscal 2013 budget proposal in a section, beginning on page 23, titled “Cutting Waste, Reducing the Deficit.”

The Medicare proposals, for example, are a mix of reduced payments to certain providers, including teaching hospitals and post-acute care facilities — as well as the higher premiums and new fees for certain beneficiaries that we mentioned above.

White House spokesman Jay Carney made this point at a press briefing on the day of Geithner’s meeting with Republican leaders.

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Longer tamoxifen use cuts breast cancer deaths

Breast cancer  patients taking the drug tamoxifen can cut their chances of having the disease come back or kill them if they stay on the pills for 10 years instead of five years as doctors recommend now, a major study finds.

The results could change treatment, especially for younger women. The findings are a surprise because earlier research suggested that taking the hormone-blocking drug for longer than five years didn't help and might even be harmful.

In the new study, researchers found that women who took tamoxifen for 10 years lowered their risk of a recurrence by 25 percent and of dying of breast cancer by 29 percent compared to those who took the pills for just five years.

In absolute terms, continuing on tamoxifen kept three additional women out of every 100 from dying of breast cancer within five to 14 years from when their disease was diagnosed. When added to the benefit from the first five years of use, a decade of tamoxifen can cut breast cancer mortality in half during the second decade after diagnosis, researchers estimate.

Some women balk at taking a preventive drug for so long, but for those at high risk of a recurrence, "this will be a convincer that they should continue," said Dr. Peter Ravdin, director of the breast cancer program at the UT Health Science Center in San Antonio.

He reviewed results of the study, which was being presented Wednesday at a breast cancer conference in San Antonio and published by the British medical journal Lancet.

"The result of this trial will have a major, immediate impact on premenopausal women," Ravdin said.

About 50,000 of the roughly 230,000 new cases of breast cancer in the United States each year occur in women before menopause. Most breast cancers are fueled by estrogen, and hormone blockers are known to cut the risk of recurrence in such cases.

Tamoxifen long was the top choice, but newer drugs called aromatase inhibitors — sold as Arimidex, Femara, Aromasin and in generic form — do the job with less risk of causing uterine cancer and other problems.

But the newer drugs don't work well before menopause. Even some women past menopause choose tamoxifen over the newer drugs, which cost more and have different side effects such as joint pain, bone loss and sexual problems.

The new study aimed to see whether over a very long time, longer treatment with tamoxifen could help.

Dr. Christina Davies of the University of Oxford in England and other researchers assigned 6,846 women who already had taken tamoxifen for five years to either stay on it or take dummy pills for another five years.

Researchers saw little difference in the groups five to nine years after diagnosis. But beyond that time, 15 percent of women who had stopped taking tamoxifen after five years had died of breast cancer versus 12 percent of those who took it for 10 years. Cancer had returned in 25 percent of women on the shorter treatment versus 21 percent of those treated longer.

Tamoxifen had some troubling side effects: Longer use nearly doubled the risk of endometrial cancer. But it rarely proved fatal, and there was no increased risk among premenopausal women in the study — the very group tamoxifen helps most.

"Overall the benefits of extended tamoxifen seemed to outweigh the risks substantially," Dr. Trevor Powles of the Cancer Centre London wrote in an editorial published with the study.

The study was sponsored by cancer research organizations in Britain and Europe, the United States Army, and AstraZeneca PLC, which makes Nolvadex, a brand of tamoxifen, which also is sold as a generic for 10 to 50 cents a day. Brand-name versions of the newer hormone blockers, aromatase inhibitors, are $300 or more per month, but generics are available for much less.

The results pose a quandary for breast cancer patients past menopause and those who become menopausal because of their treatment — the vast majority of cases. Previous studies found that starting on one of the newer hormone blockers led to fewer relapses than initial treatment with tamoxifen did.

Another study found that switching to one of the new drugs after five years of tamoxifen cut the risk of breast cancer recurrence nearly in half — more than what was seen in the new study of 10 years of tamoxifen.

"For postmenopausal women, the data still remain much stronger at this point for a switch to an aromatase inhibitor," said that study's leader, Dr. Paul Goss of Massachusetts General Hospital. He has been a paid speaker for a company that makes one of those drugs.

Women in his study have not been followed long enough to see whether switching cuts deaths from breast cancer, as 10 years of tamoxifen did. Results are expected in about a year.

The cancer conference is sponsored by the American Association for Cancer Research, Baylor College of Medicine and the UT Health Science Center.

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