http://www.therochesterdemocrat.com/ee/index.php en editor@TheRochesterDemocrat.com Copyright 2012 2012-02-03T14:46:11+00:00 http://www.therochesterdemocrat.com/index.php/weblog/fda_confirms_fungicide_in_orange_juice/ {summary} Imports, Products, Testing






WASHINGTON (AP) - The Food and Drug Administration says it has confirmed low levels of an illegal fungicide in orange juice samples taken from Florida manufacturers.

The FDA says the fungicide is far below dangerous levels, the juice is safe to drink and the orange juice won't be recalled from stores or destroyed. The juice tested was mixed with product from Brazil, where the fungicide carbendazim is used.

The government is testing for the chemical in domestic orange juice and in imports because carbendazim is not approved for use on oranges in the United States. It is used in other countries, including Brazil, to combat mold on orange trees.

The test results are the first domestic samples released by the FDA. The government started testing for the chemical after Atlanta-based Coca-Cola, which owns juice brands Minute Maid and Simply Orange, reported finding the chemical in its own juice and in competing juices late last year. Most orange juice products made by Coke and other companies contain a blend of juice from different sources, including Brazil, which is the world's largest orange producer.

The FDA said that nine of 14 samples taken from large holding tanks of juice in Florida tested positive at up to 36 parts per billion. The Environmental Protection Agency has said studies show no risks of consuming the chemical at up to 80 parts per billion and true levels of danger are probably thousands of times higher.

The agency said the juice in the tanks will packaged in hundreds of thousands of retail size containers, so the tests were a good representative sample of what will end up on store shelves. The FDA said it will do follow-up testing at the facilities but did not release the names of the companies where the samples were taken.

Though the EPA says the juice is safe, the FDA is still detaining any orange juice imports that contain the chemical at more than 10 parts per billion, which is the lowest detectable level. The agency has detained almost a quarter of 86 orange juice shipments at the border since the first of the year, hoping to phase the carbendazim out of the U.S. supply.

"We looked at products already in the country and realized there was no safety risk there, and yet carbendazim is technically illegal, we know Brazil uses it and we want to prevent it from entering the country," said FDA spokeswoman Siobhan DeLancey.

All of the imports detained are from Brazil and Canada. Canada doesn't grow oranges but purchases orange juice products from other countries, including Brazil, and then exports it to the United States.

Test results released by the FDA showed the highest levels found were in a Jan. 11 shipment of concentrate from Brazil. That shipment contained up to 60 parts per billion of the fungicide, though most samples were much lower.


Online:

FDA updates on fungicide in orange juice: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm288004.htm

]]> 2012-02-03T14:46:11+00:00 http://www.therochesterdemocrat.com/index.php/weblog/contraceptive_pill_recalled_in_us/ {summary} Recalls




BBC News Health
1 February 2012


One million packets of birth control tablets are being recalled in the US, as they might not prevent pregnancy.

The pharmaceutical company Pfizer said a "packaging error" meant the doses were not correct.

It said the tablets did not pose any health dangers, but there was a risk of "unintended pregnancy".

Pfizer is advising women affected to use non-hormonal forms of contraception immediately.

Fourteen lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and ethinyl estradiol tablets have been recalled. The lot numbers have been published on the company's website.

Throughout the month women would take 21 tablets containing active ingredients and seven which were inert.

The correct dose is essential for preventing pregnancy, however, the drug maker said: "The daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy."

Women affected have been advised to tell their doctor and return the tablets to their pharmacy.






]]> 2012-02-02T14:36:34+00:00 http://www.therochesterdemocrat.com/index.php/weblog/why_do_some_people_never_get_depressed/ {summary} Research



BBC News Magazine
30 January 2012 Last updated at 07:23 ET
By Geoff Watts BBC World Service


Confronted with some of life's upsetting experiences - marriage breakdown, unemployment, bereavement, failure of any kind - many people become depressed. But others don't. Why is this?

A person who goes through experiences like that and does not get depressed has a measure of what in the psychiatric trade is known as "resilience".

According to Manchester University psychologist Dr Rebecca Elliott, we are all situated somewhere on a sliding scale.

"At one end you have people who are very vulnerable. In the face of quite low stress, or none at all, they'll develop a mental health problem," she says.

"At the other end, you have people who life has dealt a quite appalling hand with all sorts of stressful experiences, and yet they remain positive and optimistic." Most of us, she thinks, are somewhere in the middle.

But what is this resilience? Is it something we inherit or do we learn it? Can it be traced in the chemistry of the brain? Or in its wiring, or its electrical activity? And if we lack it, can we acquire it?

The answer, regrettably, to all those questions is much the same. We don't really know. But we'd like to, and we need to. According to the World Health Organization, depression affects just over 120 million people worldwide.

"We think about a fifth of the UK population will suffer from depression at some point in their lifetime," says Bill Deakin, professor of psychiatry at Manchester University. Worryingly, he adds that more people are getting depressed now than in the past, and that it is beginning to affect younger people.

With the support of the Medical Research Council, Bill Deakin, Rebecca Elliott and their colleagues are peering into the brain, trying to fathom the origins and nature of resilience. They think that a better understanding of it might pay dividends in helping those who lack it.

The subjects of their study are a mixed bunch - intentionally so. Some have suffered bouts of depression, others have not. Some have had more than their share of adverse life events, while others have had an easier time of it.

In knowing where to start looking for the differences that might underpin resilience to depression the Manchester group has the advantage of being able to draw on previous work that has investigated resilience to post-traumatic stress disorder.

This, says Bill Deakin, has pointed them to several relevant features of brain function. They include cognitive flexibility - our capacity to adapt our thinking to different situations - and also the extent to which our brains concentrate on processing and remembering happy, as opposed to sad, information.

Emotional memory

Each subject in the Manchester study has been allocated to one of four groups based on the four possible combinations of high and low life stress, with or without depression. All have given saliva samples from which their stress hormone levels can be measured, and many of them will undergo a brain scan.

A scanning technique much used by brain researchers called functional magnetic resonance imaging allows them to see which parts of the brain are active while subjects are performing specific tasks.

"In one task we give them pictures to look at which are emotionally charged," says Rebecca Elliot. "They have to memorise them." Shortly afterward they're shown these pictures again, with others, and have to identify those they've seen already. "This probes emotional memory - how well people remember material which has an emotional component to it."

The research is not yet complete, so Rebecca Elliott can't say whether there are distinct differences in brain function between the groups. But there are encouraging hints, such as the correlations she's finding between the psychological measurements of her subjects' resilience and how they perform on some of the tests.

"For example, our early data suggest that people who are more resilient are more likely to recognise happy faces and less likely to recognise sad or fearful faces. The more resilient someone is, the better they remember positive words and pictures."

Precisely how a clinician might eventually use whatever the Manchester research reveals about our brain activity is still an open question. What we refer to as resilience is the outcome of a complex and continuing set of interactions between our genes, our body chemistry, the wiring of our brains, and our life experiences.

But broadly speaking, the hope is that an understanding of the brain activity that underpins resilience might offer pointers towards new treatments, or better ways of using existing ones.

A resilience pill?

Bill Deakin talks of using brain scanning to create what he calls a "neuroscientific profile" of an individual's problem. This might be used to identify relevant aims and goals in deciding on the best treatment.

A patient may turn out to have normally functioning cognitive flexibility but a tendency to dwell on sad thoughts. "This might allow you to tailor-make a therapy to reduce the likelihood of a further episode of depression," says Deakin. In the first instance this would most likely be a talking therapy of some kind.

Responding to the suggestion that a drug, a daily "resilience pill", tailored to our brain activity or chemistry might be a useful development, Rebecca Elliott is cautious. "I suppose this is something that would theoretically be possible," she says. "Whether people would be willing to take that kind of drug, I'm not sure."

But whatever the means, finding some way to boost resilience is an ambition well worth pursuing. To be assured of that you have only to compare Aeron's experiences with those of Pauline, another of the Manchester research subjects.

While out of work, struggling financially, and single-handedly responsible for three children, Pauline had several bouts of depression during which she felt completely isolated. "And emotionally I was very detached. I would come in and sit on my bed and cry. And when it got so bad I didn't want to be with the children, that's when I went to the doctor."

No clinician can yet prescribe what she most needs - resilience. But one day… maybe.


]]> 2012-01-31T17:09:03+00:00 http://www.therochesterdemocrat.com/index.php/weblog/magnet_toys_pose_serious_health_hazards_if_swallowed/ {summary} Child Health, Toys



Lena H. Sun
Washington Post
Friday, Jan 27, 2012


Meredith DelPrete, age 10, was playing at school one day and did something that she said is popular among kids her age: pretending to have a pierced tongue. The Fairfax County fifth-grader took two tiny magnetic balls out of her pocket and placed one on top of her tongue and the other on the underside. The magnets, the size of a BB, are extremely powerful. They made it look like she had a tongue stud. She opened her mouth to show a friend.

That’s when the tiny silver orbs rolled off.

“I could feel them in the back of my throat. I tried to get them out, but I couldn’t. So I just swallowed them,” she said in an interview this week.

That accidental swallowing led to five days at Inova Fairfax Hospital, at least 10 X-rays, three CT scans and an endoscopy. Finally, on Jan. 20, a surgeon used a metal instrument to manipulate the magnets into her appendix, avoiding major surgery. He then removed her appendix, and the magnets, doctors said.

Doctors and consumer product safety officials say the growing popularity of the small ball-bearing magnets pose a unique health hazard. Not only are they in children’s toys, but they are also in jewelry and are marketed as stress-relief toys for adults. The magnets that Meredith received as a gift are a popular brand known as Buckyballs, which are 5 mm in diameter. The labels warn to keep them away from children, not to put them in the nose or mouth, and that swallowed magnets can cause serious injury or death.

Hospitalized at the same time as Meredith was another 10-year-old, a boy, who had swallowed three ball-bearing magnets. He eventually passed them without incident, doctors said. On Wednesday, a third case, involving a 9-year-old boy, was brought to Inova Fairfax and transferred to Georgetown University Hospital, a doctor said. The boy’s condition could not be immediately determined.

Neither Meredith nor the other 10-year-old suffered serious injury, doctors said.

When two or more magnets are swallowed, they can attract each other internally, resulting in serious injuries, such as small holes in the stomach and intestines, intestinal blockage, blood poisoning and even death, according to safety and health officials.

Last November, the Consumer Product Safety Commission issued its first product-wide warning about ball-bearing magnets in adult products in a joint news release with manufacturers. The commission had received 22 reports of incidents involving the magnets from 2009 through October 2011, it said. The actual number is probably higher, doctors said. Inova Fairfax alone had three cases in less than a week.

Although parents of younger children are generally warned about the hazards of small toys, there is less public awareness among parents — and even medical professionals — about the risk of magnets, especially when older children use them to emulate tongue or lip piercings, according to parents, doctors and safety officials.

“The potential for serious injury and death if multiple magnets are swallowed demands that parents and medical professionals be aware of this hidden hazard,” said Commission Chairman Inez Tenenbaum. “This is not a children’s product and should be kept away from children.”

Three doctors who treated Meredith said they did not know children were using magnets to mimic piercings.

“I had not heard about it until that evening,” said Sharon Day, an emergency-room doctor on duty when Meredith and the other 10-year-old were hospitalized. Day, who lives in Montgomery County, quizzed her two high-school-age children. “I said to my kids, ‘Are you guys doing this?’ . . . They weren’t, but they had heard about it.”

Voluntary recalls

Marsha Kay, who chairs the pediatric gastroenterology department at the Cleveland Clinic’s Children’s Hospital, said magnet ingestion is increasingly being reported among children in recent years.

“They’re very popular and perceived to be safe,” she said.

The first reports in the United States began appearing in 2005. That year, a 20-month-old boy died after swallowing nine cylindrical magnets from an older sibling’s toy building set, according to the U.S. Centers for Disease Control and Prevention. The magnets had magnetically joined across two loops of intestine, causing a twisting of the bowel that led to a fatal bloodstream infection. Since 2008, the Consumer Product Safety Commission has received more than 200 reports of children swallowing all kinds of magnets; at least 18 children required emergency surgery to remove the magnets.

At least two major toy manufacturers have issued voluntary recalls of toys with magnets since 2006; in 2010, the maker of Buckyballs and the commission issued a voluntary recall of Buckyballs magnet sets to update the labeling.

The recent reports may be linked to the holiday season. Kay said she received a call this week from a doctor elsewhere in the country about an accidental ingestion by a school-age child.

Stephen Kim, the Annandale pediatric surgeon who removed the magnets from Meredith, said he and the two other doctors in the practice have received more calls from pediatricians and gastroenterologists recently. As a result, they are trying to come up with a treatment protocol. “We’re trying to discuss a unified response to anyone who consults us,” he said.

“This is a big, big problem,” said Ben Enav, the pediatric gastroenterologist who treated Meredith and the 10-year-old boy hospitalized at the same time. In the past year, he has had a third case, another school-age child who swallowed the same type of magnets and needed surgery because of a perforated intestine.

“I can see how an innocent bystander can think this seems all very benign and nothing to worry about, but if these things get separated and are floating through your intestine,” they can cause serious injury, he said.

Even urgent-care and emergency-room clinicians have assumed — incorrectly — that they can send a child who has swallowed magnets home. “They are not aware of how serious a problem this is,” Enav said.

Craig Zucker, chief executive for Maxfield & Oberton, the manufacturer of Buckyballs, said the company puts warning labels in five places, inside and outside the boxes. The company works closely with the safety commission to spread the message that the magnets should be kept from children.

“We don’t sell to stores that sell exclusively children’s products or toy stores,” he said. “We are doing everything we can to make sure it’s not getting to children.”

Brookstone, one of many retailers that carry the magnets, says they are a popular item. A boxed set of 125 Buckyball magnets sells for $24.99. A company spokeswoman said new product training includes warnings that they are for adults only.

‘My favorite’

Meredith said she likes the Buckyballs because “you can use them for fake piercings on your ear, your nose, lip or tongue.” On braces, too. The magnets are also very strong, she said, “so you can make different stuff out of them.” Many friends already had them, so she was excited to get them for Christmas. Her siblings, 11 and 13, also each got a box.

She didn’t read the warnings on the box about not putting the magnets in her nose, her mouth or ears. “I just opened it,” she said.

“It was probably my favorite of everything I got until I swallowed it,” she said of the magnets.

On Jan. 17, a Tuesday, she was in the library at Oak View Elementary School, checking out a book with a friend. Two tiny magnets were in her pocket.

After she swallowed them, Meredith, at her friend’s urging, told the school nurse. The nurse sent Meredith back to class, but as a courtesy, notified Meredith’s mother, Helen DelPrete. DelPrete called her pediatrician, Gary Bergman, as a precaution, and was told to take Meredith to the emergency room immediately.

Luckily for Meredith, the two magnets had connected in her esophagus, making the situation less dangerous, doctors said. For four days, the doctors monitored the movement of the magnets in Meredith’s body. She was not allowed to eat. They proceeded with surgery after the magnets became embedded in her large intestine.

Helen DelPrete said her husband bought the magnets for the children and didn’t notice the warning labels. She said she wasn’t aware of the warnings until after Meredith was hospitalized. “It’s etched on the plastic container [holding the magnets], but you can’t even read it — it’s the same color as the plastic container,” she said.

The hospital charges so far are about $22,000 but when the individual doctors’ charges are added, the total cost could be twice that figure, she said.

She has confiscated all the magnets from her children. Meredith says she still wants to play with them but wouldn’t put them anywhere near her nose or mouth.


]]> 2012-01-28T01:36:45+00:00 http://www.therochesterdemocrat.com/index.php/weblog/worth_all_the_sweat/ {summary} Lifestyle




The Economist
January 21, 2012


ONE sure giveaway of quack medicine is the claim that a product can treat any ailment. There are, sadly, no panaceas. But some things come close, and exercise is one of them. As doctors never tire of reminding people, exercise protects against a host of illnesses, from heart attacks and dementia to diabetes and infection.

How it does so, however, remains surprisingly mysterious. But a paper just published in Nature by Beth Levine of the University of Texas Southwestern Medical Centre and her colleagues sheds some light on the matter.

Dr Levine and her team were testing a theory that exercise works its magic, at least in part, by promoting autophagy. This process, whose name is derived from the Greek for “self-eating”, is a mechanism by which surplus, worn-out or malformed proteins and other cellular components are broken up for scrap and recycled.

To carry out the test, Dr Levine turned to those stalwarts of medical research, genetically modified mice. Her first batch of rodents were tweaked so that their autophagosomes—structures that form around components which have been marked for recycling—glowed green. After these mice had spent half an hour on a treadmill, she found that the number of autophagosomes in their muscles had increased, and it went on increasing until they had been running for 80 minutes.

To find out what, if anything, this exercise-boosted autophagy was doing for mice, the team engineered a second strain that was unable to respond this way. Exercise, in other words, failed to stimulate their recycling mechanism. When this second group of modified mice were tested alongside ordinary ones, they showed less endurance and had less ability to take up sugar from their bloodstreams.

There were longer-term effects, too. In mice, as in people, regular exercise helps prevent diabetes. But when the team fed their second group of modified mice a diet designed to induce diabetes, they found that exercise gave no protection at all.

Dr Levine and her team reckon their results suggest that manipulating autophagy may offer a new approach to treating diabetes. And their research is also suggestive in other ways. Autophagy is a hot topic in medicine, as biologists have come to realise that it helps protect the body from all kinds of ailments.

The virtues of recycling

Autophagy is an ancient mechanism, shared by all eukaryotic organisms (those which, unlike bacteria, keep their DNA in a membrane-bound nucleus within their cells). It probably arose as an adaptation to scarcity of nutrients. Critters that can recycle parts of themselves for fuel are better able to cope with lean times than those that cannot. But over the past couple of decades, autophagy has also been shown to be involved in things as diverse as fighting bacterial infections and slowing the onset of neurological conditions like Alzheimer’s and Huntington’s diseases.

Most intriguingly of all, it seems that it can slow the process of ageing. Biologists have known for decades that feeding animals near-starvation diets can boost their lifespans dramatically. Dr Levine was a member of the team which showed that an increased level of autophagy, brought on by the stress of living in a constant state of near-starvation, was the mechanism responsible for this life extension.

The theory is that what are being disposed of in particular are worn-out mitochondria. These structures are a cell’s power-packs. They are where glucose and oxygen react together to release energy. Such reactions, though, often create damaging oxygen-rich molecules called free radicals, which are thought to be one of the driving forces of ageing. Getting rid of wonky mitochondria would reduce free-radical production and might thus slow down ageing.

A few anti-ageing zealots already subsist on near-starvation diets, but Dr Levine’s results suggest a similar effect might be gained in a much more agreeable way, via vigorous exercise. The team’s next step is to test whether boosted autophagy can indeed explain the life-extending effects of exercise. That will take a while. Even in animals as short-lived as mice, she points out, studying ageing is a long-winded process. But she is sufficiently confident about the outcome that she has, in the meantime, bought herself a treadmill.


]]> 2012-01-23T12:16:47+00:00 http://www.therochesterdemocrat.com/index.php/weblog/new_autism_definition_may_exclude_many_analysis_suggests/ {summary} Health Spending




Source: NY Times


Proposed changes in the definition of autism would sharply reduce the rising rate at which the disorder is diagnosed and may make it harder for many people who would no longer meet the criteria to get health, educational and social services, a new analysis suggests.

The definition is being reviewed by an expert panel appointed by the American Psychiatric Association, which is completing work on the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders. The DSM, as the manual is known, is the standard reference for mental disorders, driving research, treatment and insurance decisions.

The results, presented Thursday at the Icelandic Medical Association, are still preliminary but offer the latest and most dramatic estimate of how tightening the criteria for autism could affect the rate of diagnosis. Rates of autism and related disorders such as Asperger's syndrome have taken off since the early 1980s, to prevalence rates as high as 1 in 100 children in some places. Many researchers suspect that these numbers are inflated because of vagueness in the current criteria.

"The proposed changes would put an end to the autism epidemic," said Dr. Fred Volkmar, director of the Child Study Center at Yale University School of Medicine and an author of the new analysis. "We would nip it in the bud -- think of it that way."

Experts working on the new definition questioned the estimate. "I don't know how they're getting those numbers," said Catherine Lord, a member of the task force.

Previous projections have concluded that far fewer people would be excluded under the proposed change, said Lord, director of the Institute for Brain Development, a joint project of New York-Presbyterian Hospital, Weill Cornell Medical College, Columbia University Medical Center and the New York Center for Autism.

At least 1 million children and adults have a diagnosis of autism or a related disorder, such as Asperger's syndrome or "pervasive developmental disorder, not otherwise specified" -- or PDD-NOS. The proposed change would consolidate all three diagnoses under one category, autism spectrum disorder. The likelihood of being left out under the new definition depended on the original diagnosis: About a quarter of those identified with classic autism in 1993 would not be so identified under the proposed criteria; about three quarters of those with Asperger's would not qualify; and 85 percent of those with PDD-NOS would not.


]]> 2012-01-20T16:13:35+00:00 http://www.therochesterdemocrat.com/index.php/weblog/us_wants_effective_alzheimers_treatment_by_2025/ {summary} Alzheimers






WASHINGTON (AP) - The government is setting what it calls an ambitious goal for Alzheimer's disease: Development of effective ways to treat and prevent the mind-destroying illness by 2025.

The Obama administration is developing the first National Alzheimer's Plan to find better treatments for the disease and offer better day-to-day care for those afflicted.

A newly released draft of the overall goals sets the 2025 deadline, but doesn't provide details of how to fund the necessary research to meet that target date. Today's treatments only temporarily ease some dementia symptoms, and work to find better ones has been frustratingly slow.

A committee of Alzheimer's experts begins a two-day meeting Tuesday to help advise the government on how to finalize the plan.

An estimated 5.4 million Americans have Alzheimer's or similar dementias. It's the sixth-leading killer, and is steadily growing as the population rapidly ages. By 2050, 13 million to 16 million Americans are projected to have Alzheimer's, costing $1 trillion in medical and nursing home expenditures.

The national plan is supposed to tackle both the medical and social aspects of dementia, and advocacy groups had urged that it set a deadline for progress.

Among the draft's other goals:

_Improve timely diagnosis. A recent report found as many as half of today's Alzheimer's sufferers haven't been formally diagnosed, in part because of stigma and the belief that nothing can be done. Symptomatic treatment aside, a diagnosis lets families plan, and catching the disease earlier would be crucial if scientists ever find ways to slow the disease's progress.

_Improve support and training for families so they know what resources are available for patients and what to expect as dementia worsens.

Alzheimer's sufferers gradually lose the ability to do the simplest activities of daily life and can survive that way for a decade or more. In meetings around the country last summer and fall, families urged federal health officials to make sure the national plan addresses how to help patients live their last years at home without ruining their caregivers' own health and finances.


]]> 2012-01-17T11:50:15+00:00 http://www.therochesterdemocrat.com/index.php/weblog/woman_injects_bath_salts_loses_arm_to_flesh-eating_bacteria/ {summary} Drug News



by Nancy Shute
npr NEWS
January 13, 2012


Stimulant chemicals dubbed "bath salts" are increasingly injected for a high.

Using illicit drugs can cause lots of bad things to happen. But being attacked by flesh-eating bacteria usually isn't one of them.

Yet that's what happened to an unfortunate young woman who had injected the increasingly popular stimulant drug called "bath salts."

The 34-year-old woman showed up at a New Orleans hospital with a painful, swollen arm after she attended a party. She had a small red puncture mark on her forearm.

The doctors diagnosed a skin infection and put her on intravenous antibiotics. Things got better. But two days later, the swelling suddenly returned. At that point, she told them that she had injected the bath salts (not to be confused with real bathing aids) at the party.


The doctors cut open the skin on the woman's forearm and discovered a raging infection and dead muscle. They knew immediately that she was in serious trouble. As they cut skin farther up her arm in an effort to find healthy tissue, the infection was moving so fast they could see flesh dying right before their eyes.

In the end, doctors amputated the woman's entire right arm and shoulder to stop the infection, and also performed a radical mastectomy and skin grafts. The woman survived, and is now in rehabilitation. Her case was reported online in the journal Orthopedics.

This tale certainly got Shots' attention. Bath salts is a relatively new problem in the world of recreational drugs. The name covers several synthetic chemicals, including mephedrone and MDPV, short for methylenedioxypyrovalerone, that give a stimulant high similar to meth or cocaine. The stuff is sold under names like Vanilla Sky or Ivory Wave.

The Drug Enforcement Administration invoked emergency powers in October to make the drug illegal.

Until recently most people who have taken bath salts have either snorted or smoked the drug. But injection gives a quicker, stronger high, so drug abuse experts aren't surprised to see some people going that route.

This appears to be the first known case of a person contracting a flesh-eating infection from shooting up bath salts.

Infections with flesh-eating bacteria are rare, fortunately. But there's a risk of infection with any sort of injection, even in a hospital. And as Robert Russo, an orthopedic resident who helped treat the woman, tells Shots: "When you're out in the street with these drugs the risk is significantly higher."

Russo had gotten used to treating gunshot wounds in the ER, but was still shaken by this case. "It's one of those horrible things that starts out as no big deal," he says. "Then the person ends up losing an extremity."

Bath salts is a bad drug, Russo adds. This woman's nightmarish experience "is just one more reason to stay away from it."


]]> 2012-01-14T14:05:18+00:00 http://www.therochesterdemocrat.com/index.php/weblog/excedrin_bufferin_nodoz_and_gas-x_recalled/ {summary} Over The Counter Remedies




by Scott Hensley
npr NEWS


It's enough to give you a headache. Some of the pills inside the bottle of Excedrin in your bathroom cabinet might be the wrong ones.

Drugmaker Novartis is recalling a slew of nonprescription medicines because of of quality issues at a factory in Lincoln, Neb.

Look out for Excedrin and NoDoz with expiration dates of Dec. 20, 2014, or earlier. Bufferin and Gas-X Prevention with expiration dates of Dec. 20, 2013, or earlier, are also affected. The complete rundown of affected medicines is here.

The company says there may be chipped or broken tablets inside some bottles. There's a bigger worry, though. It's possible that "stray tablets, capsules, or caplets," as Novartis puts it, could have found their way into the container of medicine you bought.


The company explains:

"Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient."

Novartis says it's unaware of any health problems caused by the quality lapses that led to the recalls.

The factory that makes the affected drugs has suspended production while Novartis sorts out the problems there and deals with the recalls.

The Food and Drug Administration inspectors alleged numerous problems at the Nebraska plant last year. Since 2009, Novartis "failed to adequately investigate" 166 complaints about pill mix-ups, the FDA said. And when the company did mount investigations, they didn't go far enough, the agency said, citing examples involving mix-ups of Excedrin Migraine caplets, tablets and gelcaps.

Overall, the FDA alleged the quality unit at the factory has been understaffed and "has consistently failed to review critical complaints" for drugs made and packaged there.

Novartis said it's working to remedy the problem. In a statement, CEO Joseph Jimenez said, "We are making the necessary investments and committing the right resources" to make sure that quality standards are upheld across the company.

In a related move, the FDA is telling consumers to check bottles of narcotic painkillers sold by Endo Pharmaceuticals to make sure the pills are all the same. Bottles of Percocet, Percodan, Opana and some other Endo drugs are manufactured and packaged at the same Novartis plant. The bottles may contain stray pills from a different kind of medicine, the FDA said.

And the Associated Press reports that the FDA said it's possible that some of Novartis' over-the-counter pills may accidentally have been packaged with some of Endo's narcotic painkillers. "The likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low and patients should not be unduly alarmed," FDA's Dr. Edward Cox said, according to the AP.

]]> 2012-01-14T14:03:32+00:00 http://www.therochesterdemocrat.com/index.php/weblog/cvs_caremark_settles_charges_over_prescription_prices/ {summary} Drug News



January 12, 2012
By REED ABELSON and NATASHA SINGER
The NY Times


After more than two years of investigation, CVS Caremark agreed on Thursday to pay $5 million to settle charges by the Federal Trade Commission that the company had misrepresented the price of certain prescription drugs in one of its Medicare drug plans, causing many older consumers to pay significantly higher prices than advertised.

The settlement comes at a time of intensive government scrutiny of pharmacy benefits managers like CVS Caremark, companies that manage prescription drug plans for employers and insurers. The F.T.C. is currently reviewing the proposed merger of the two main competitors to CVS Caremark: Medco Health and Express Scripts.

In the case of Medco and Express Scripts, regulators are examining whether the combination would create a player with too much market share.

With CVS Caremark, the agency looked into whether the merger of one of the largest drugstore chains with one of the largest pharmacy benefits managers had given the company an unfair market advantage in steering customers and obtaining information about competing pharmacies. CVS Caremark is one of the country’s largest pharmacy benefits managers with a network of about 65,000 pharmacies, including more than 7,300 of its own drugstores.

In 2009, some legislators, labor unions, pharmacies and consumer groups raised concerns about potentially anti-competitive and anti-consumer business practices by CVS Caremark. The F.T.C. opened an investigation early that year.

On Thursday, the agency dismissed the more serious allegations of anti-competitive behavior. The agency found only one violation — that one of the company’s Medicare drug plans, then called RxAmerica, had misled some consumers about drug prices.

“After a thorough and comprehensive review of other consumer protection and competition issues in this matter, the F.T.C. issued a letter closing the investigation,” the agency said in a press release Thursday morning.

In a statement, CVS Caremark said that the settlement related only to the practices of RxAmerica, a subsidiary of Longs Drug Stores, that took place before CVS Caremark’s acquisition of Longs in October 2008. (While much of the incorrect pricing did occur before the purchase, the F.T.C. asserted that some continued after the acquisition.)

CVS Caremark said the subsidiary had inadvertently posted inaccurate prices for certain generic drugs on a Web site maintained by the Centers for Medicare and Medicaid Services and that the company had rectified the pricing problem upon learning of it.

“CVS Caremark is pleased to have reached an agreement with the F.T.C. that ends the investigation and enables us to continue our focus on offering unique, innovative products and services that differentiate us and benefit consumers,” said Larry Merlo, the chief executive of CVS Caremark, in the statement. The agency’s decision removes a significant overhang for the company.

In 2006, when CVS proposed to merge with Caremark, executives pledged that the new company would put up a firewall to keep the activities of its own stores separate from the benefits manager, which processes prescriptions from competing pharmacies. Tom Ryan, then the company’s chief executive, said in a conference call with investors in 2006 that the merged company would “be agnostic to where the consumer fills their prescription.”

But pharmacies and consumer groups asserted in their complaints to regulators that the two divisions of the company had shared consumers’ records, steering people to the company’s own retail stores and mail-order operations, which gave CVS Caremark an unfair advantage over its competitors. At the time, some consumer advocates called for the agency to dissolve the merger.

The F.T.C. mounted a sweeping investigation, involving its bureau of consumer protection, bureau of economics and bureau of competition — a highly unusual effort by the agency. But the agency ultimately cited CVS Caremark for only one narrow violation.

In the statement, Douglas A. Sgarro, the chief legal officer of CVS Caremark said: “It is important to note that, at the conclusion of this comprehensive investigation, the F.T.C. made no allegations of antitrust law violations or anti-competitive behavior associated with any of our business practices, products or service offerings.”

The F.T.C. charged that from 2007 through at least November 2008, the RxAmerica plan posted on its Web site and supplied to some third-party Web sites incorrect prices for Medicare Part D prescription drugs at two pharmacy chains, CVS and Walgreens. The posted prices caused many people to choose the CVS Caremark plan and pay as much as 10 times more than they had expected, according to the F.T.C. complaint. In some cases, the higher prices unexpectedly pushed older consumers into the so-called “donut hole” — a gap in prescription drug coverage that requires people to pay out of pocket for their medicines.

The settlement requires CVS Caremark to pay $5 million to reimburse consumers for the price difference and bars the company from making deceptive claims about drug prices. The agency said it planned to mail checks to consumers who were deceived.

In 2009, CVS Caremark settled earlier charges from regulators that it had failed to protect sensitive personal information of its customers and employees. In a separate but related agreement, the company paid $2.25 million to the Department of Health and Human Services to resolve allegations that it violated the Health Insurance Portability and Accountability Act, the health privacy law.



]]> 2012-01-12T21:01:49+00:00 http://www.therochesterdemocrat.com/index.php/weblog/brazil_bans_sale_of_dutch_cos_breast_implants/ {summary} Implants







SAO PAULO (AP) - The sale of Dutch-branded breast implants made by a French company at the center of an international scandal has been banned in Latin America's biggest country, Brazil's health ministry said Wednesday.

The ministry's National Agency for Sanitary Vigilance said in a statement that the banned implants were sold by Rofil Medical Nederland BV.

The agency later announced that the government will pay for the removal of ruptured implants sold by Rofil and France's now-defunct Poly Implant Prothese company.

The agency said that so far it knows of 39 women who are entitled to the have their implants removed free of charge.

Brazil and many other nations already have banned implants from the PIP company that were made with cheap, industrial-grade silicone instead of medical-grade gel. The agency said Rofil had outsourced the production of its implants to PIP.

"The government will only pay for the removal of ruptured implants," an agency official said by telephone. "We are not offering free preventive surgeries." He declined to be identified because he was not authorized to speak to the press.

The agency says it did not know how many Rofil implants were imported and sold in Brazil.

In late December the agency said Brazil imported 34,631 implants made by PIP and that 24,534 of them had been sold.



]]> 2012-01-12T12:52:45+00:00 http://www.therochesterdemocrat.com/index.php/weblog/boston_lawsuit_claims_des-breast_cancer_link/ {summary} Cancer



DENISE LAVOIE
Published: 1/8/2012
Associated Press


BOSTON (AP) - Arline MacCormack first heard about DES from her mother when she was 17. Three decades later, MacCormack believes that the drug her mother took to prevent miscarriages caused her to develop breast cancer at age 44.

MacCormack, of Newton, is one of 53 women from around the country who are suing drug companies who made and promoted DES for millions of pregnant women from about 1938 to the early 1970s. In 1971, the U.S. Food and Drug Administration told doctors to stop prescribing DES for their pregnant patients after a study found that taking DES during pregnancy appeared to increase the risk of developing a rare vaginal cancer years later for DES daughters in their teens and 20s.

DES, or diethylstilbestrol (dahy-eth-uhl-stil-bes'-trawl), is a synthetic estrogen that was prescribed to millions of women in the United States, Europe and other countries to prevent miscarriages, premature birth and other problems.

The case in Boston is being closely watched by DES daughters around the country. Thousands of lawsuits have been filed since the 1970s alleging links between DES and cervical and vaginal cancer, as well as infertility problems. Many of those cases were settled before trial. The Boston case is believed to be the first major litigation alleging a link between DES and breast cancer in DES daughters over the age of 40.

MacCormack, now 50, said she was stunned when she was diagnosed with breast cancer six years ago after having mammograms every six months since she turned 40 because she had had several benign cysts removed over the years.

"The characteristics of my cancer were for women over 60 typically. It wasn't the type of cancer a 40-year-old or a 44-year-old woman gets," said MacCormack.

"When I read the research that's been done, I found I had more chance of getting it because my mom took DES," she said.

The women's lawyers say their case is supported by a recent study that suggests that breast cancer risk is nearly doubled in DES daughters over the age of 40. The average woman has about a 1 in 50 chance of developing breast cancer by 55. The study, led by Dr. Robert Hoover, a researcher at the National Cancer Institute, found that the chance for DES daughters is 1 in 25.

The lawsuit alleges that 14 drug manufacturers - including Eli Lilly and Co. and Bristol-Myers Squibb Co.- withheld from doctors and the FDA reports that showed DES did not prevent miscarriages and raised serious questions about the safety of the drug.

"This drug, DES, was the biggest human experiment of quackery in the history of medicine," said Aaron Levine, a Washington, D.C., lawyer who filed the Boston lawsuit and represents another 18 DES daughters making similar claims.

Representatives and lawyers for Eli Lilly and Bristol-Myers Squibb declined to comment on the lawsuit.

In court and in public documents, the companies argue that a firm link between DES and breast cancer has not been established and that the DES daughters who are suing them have not shown that DES caused their cancers.

"We believe these claims are without merit and are prepared to defend against them vigorously," Eli Lilly said in its most recent annual report.

The drug companies also argue that the medical community does not generally accept that fetal exposure to DES causes breast cancer.

"There is not a single published study, a respected medical treatise or textbook, nor a pronouncement by one of the prominent societies dedicated to the discovery of cancer causes which claims a causal link between prenatal DES exposure and breast cancer has been proven," Bristol-Myers Squibb argued in a motion to exclude the testimony of the plaintiffs' experts.

U.S. Magistrate Judge Marianne Bowler has heard testimony from a dozen experts on both sides during a hearing on the drug companies' motions, which argue that the opinions of the women's experts are not based on reliable science.

If Bowler grants the drug companies' motion, the case will not go to trial, Levine said. But if she allows the plaintiffs' experts to testify, the case can proceed to trial.

Final arguments on the motion are scheduled for Jan. 19 in U.S. District Court.

DES was prescribed at a time when medical advice was rarely questioned and drugs were not subjected to the kinds of rigorous clinical trials they are today, said Dr. Michael Grodin, a professor of medical ethics at Boston University's School of Public Health. Grodin said proving a link between DES and the plaintiffs' breast cancer could be difficult.

"There's an issue of causation, but even if it did cause the cancer, that doesn't mean there was negligence," Grodin said.

"The question of negligence is what did they know, when did they know it and what did they do about it? Those are all in contention," he said.

Jackie White, 48, of Centerburg, Ohio, a plaintiff in the lawsuit, was diagnosed with breast cancer in 2010 at age 47. Tests showed 20 tumors in one breast and two pre-cancerous lumps in the other. The cancer had also spread to her lymph nodes. She had a double mastectomy, and did six months of chemotherapy and seven weeks of radiation.

White said her mother, a nurse, told her at age 13 that she had taken DES while pregnant, prompting White to get regular gynecological exams and mammograms over the years. She said she has no family history of breast cancer.

White said it wasn't until she saw high estrogen levels in her pathology reports that she began to wonder whether DES could have caused her cancer.

"I exercise daily. I ate healthy, low-fat, did all of the maintenance screenings that a person needs - self-exams, mammograms, OB-GYN appointments - eliminated the exposure to birth control or things like that, just like doctors recommended," she said.

"I'm not any of the things that are the highest-known reasons for risk factors for breast cancer."



]]> 2012-01-09T13:18:34+00:00 http://www.therochesterdemocrat.com/index.php/weblog/the_good_city_life_why_new_yorks_life_expectancy_is_the_highest_in_the_nati/ {summary} Environment


Good News
December 30, 2011
Source:
http://www.good.is/post/the-good-city-life-why-new-york-s-life-expectancy-is-the-highest-in-the-nation/


Most of us take for granted that urban dwellers are more stressed than country dwellers. Hey, it's even proved by science! Not only that, their day-to-day existence is polluted, crime-ridden, and filled with hedonistic temptations. So they must have lower life expectancies, right? Wrong. In fact, the latest data from the Bureau of Vital Statistics shows New York City—my hometown—has the highest life expectancy in the country. Babies born in 2009 can expect to live a record 80.6 years. That's almost three years longer than a decade ago, and more than two years longer than the current national average of 78.2 years.

Mayor Bloomberg is attributing the good news to policy: anti-smoking and anti-obesity campaigns, higher taxes on cigarettes, and calorie-count requirements for fast food restaurants. The city has also expanded testing and treatment of people with HIV and upped the quality of obstetric and pediatric care. But once you look past the press releases, there are far more wide-ranging reasons for why New Yorkers are lasting longer.

First, we don't spend our entire lives in cars. We walk everywhere. With narrow streets, an abundance of stores, and a dearth of parking, the city is practically designed to make us walk. Before we get on the subway, we walk there, and after we arrive at our stop, we climb numerous flights of stairs. We also walk faster than the average American; in a recent study, New Yorkers were ranked as the fastest pedestrians in the country. To some, that's a sign that we're rude and obnoxious. To scientists, it's a sign we're going to live longer.

Our old people also have it much better than the elderly in bucolic settings. The essentials—food, medicine, laundromats, parks—are usually mere blocks from their homes. The hospital is likely a shorter distance away, too. High population density means a plethora of neighbors who can look after each other. When people live on top of each other, the likelihood of social isolation plummets—and the age of death rises.

Life expectancy isn't the whole story—just because someone is old doesn't mean they're able to live a pleasurable and fulfilling life. But cities like New York tend to provide that, too. There's something to be said for mental stimulation, which New York City delivers in droves. Studies have shown that cultural attractions getting people out of the house and exercising their brains elongate life. So do friends. So, apparently, do random people with crazy outfits walking down the street. The more variety in one's daily life, the more life is, literally, worth living.

Of course, "getting away from it all" is valuable, too. There's a reason why retirees flock to Florida and Arizona. And like everywhere, all New York life isn't created equal. The life expectancy varies wildly by socioeconomic class; unsurprisingly, the Bronx has the lowest age of death. This disparity is made worse by a rapidly gentrifying city (although studies have shown that the presence of wealthier people has a "spillover effect" on nearby neighborhoods). Despite the caveats, this newest data makes it clear: It's high time for the myth of the "urban health penalty to die out.


]]> 2011-12-31T10:18:38+00:00 http://www.therochesterdemocrat.com/index.php/weblog/german_doctor_discusses_arthritus_treatments/ {summary}


Thursday, December 29, 2011
By Shaun Assael
ESPN The Magazine


The doctor that New York Yankees star Alex Rodriguez traveled to Germany to see for his aching knee and shoulder is a former physician for Pope John Paul II who claims to be a miracle worker when it comes to reversing arthritis.

A long list of Hollywood stars and pro athletes have travelled to Dusseldorf to seek treatment from Peter Wehling, a brash molecular scientist with a taste for celebrity. His website shows him arm and arm with patient Nick Nolte. Golfer Fred Couples wrote an introduction to Wehling's recent book, The End of Pain. But it took the Los Angeles Lakers' Kobe Bryant, who sought help for his ailing right knee this summer, to get A-Rod interested in Wehling's pioneering treatments.

As Yankees general manager Brian Cashman told reporters this week, "Kobe had maintained, according to Alex, that he felt significantly better because of it."

When asked about it Thursday, Bryant confirmed he'd given Wehling's number to Rodriguez.

"... I just told him it made a huge difference for me," he said.

Wehling's treatment involves isolating growth factors and other healing agents in his patient's blood that stop a particularly destructive arthritic agent known as interleukin-1, which causes degeneration of the joints. After he incubates and supercharges the proteins, Wehling gets a serum that he says is up to 1,000-times higher in the arthritis fighting growth factors than normal blood.

In an interview with ESPN The Magazine, Wehling claimed to have a 90 percent success rate by genetically screening his patients to personalize their serums.

"I am the only one to have found a way to cure arthritis," he said.

According to the New York Post, the Yankees sought guidance from Major League Baseball before allowing A-Rod to travel to Dusseldorf on Dec. 5 for treatment on his right knee, which had surgery for a slightly torn meniscus this summer. In a conference call with reporters, Cashman said the league permitted the procedure.

But MLB's medical director, Gary Green, told ESPN New York that the league did not give the Yankees any green light.

"We don't have a mechanism for a medical approval process," he said. "We just tell the teams to make sure their players follow state and local laws."

Wehling recently opened an outpost of his clinic in Los Angeles with veteran anti-aging specialist, Chris Renna, and another in New York with neurologist Douglas Schottenstein, who told the New York Post that he's done more than 50 procedures.

But one reason that A-Rod may have travelled to Dusseldorf is because it unclear whether the treatment meets the standards of the U.S. Food & Drug Administration. The agency has issued several sternly worded advisories in recent months, warning orthopedists to avoid incubating blood more than a few hours to boost its healing properties. Wehling's procedure involves incubating the blood for a day.

"I may be wrong, but I was under the impression that the FDA doesn't allow us to do this in our country," said Jim Bradley, the Pittsburgh Steelers team doctor and an orthopedist at the University of Pittsburgh Medical Center.

The FDA only allows treatments involving "minimal manipulation," which federal statue defines as "processing that does not alter the relevant biological characteristics of cells or tissues."

In an interview, Renna defended the work, saying, "We're not altering the characteristics of anything."

In the separate interview, Wehling told The Magazine, "We do it at the moment only on low profile and recommendation, and we do not advertise it."

Wehling began his research as an adjunct professor at the University of North Carolina at Chapel Hill last decade, doing studies on lab rats.

An early partner in his work, Chris Evans, an orthopedics professor at Harvard Medical School, says, "He's a friend of mine, but he's also the only one to have done clinical trials."

Those trials, Evans says, prove that Wehling's work stops one of the most damaging byproducts of diseased joints -- interleukin -- from attaching to receptor sites and causing a cascade of damage.

The Yankees thoroughly researched that work, and Cashman told reporters this week that "there appeared to be no downside" to having Rodriguez try it.

But MLB's Green isn't willing to endorse it yet.

"It's still such an evolving field, it's hard to get a handle on some of these products," he says.

Shaun Assael is a senior writer for ESPN The Magazine. ESPNLosAngeles.com's Dave McMenamin contributed to this report.


]]> 2011-12-31T09:53:55+00:00 http://www.therochesterdemocrat.com/index.php/weblog/preventive_care_its_free_except_when_its_not/ {summary} Health Insurance






CHICAGO (AP) - Bill Dunphy thought his colonoscopy would be free.

His insurance company told him it would be covered 100 percent, with no copayment from him and no charge against his deductible. The nation's 1-year-old health law requires most insurance plans to cover all costs for preventive care including colon cancer screening. So Dunphy had the procedure in April.

Then the bill arrived: $1,100.

Dunphy, a 61-year-old Phoenix small business owner, angrily paid it out of his own pocket because of what some prevention advocates call a loophole. His doctor removed two noncancerous polyps during the colonoscopy. So while Dunphy was sedated, his preventive screening turned into a diagnostic procedure. That allowed his insurance company to bill him.

Like many Americans, Dunphy has a high-deductible insurance plan. He hadn't spent his deductible yet. So, on top of his $400 monthly premium, he had to pay the bill.

"That's bait and switch," Dunphy said. "If it isn't fraud, it's immoral."

President Barack Obama's health overhaul encourages prevention by requiring most insurance plans to pay for preventive care. On the plus side, more than 22 million Medicare patients and many more Americans with private insurance have received one or more free covered preventive services this year. From cancer screenings to flu shots, many services no longer cost patients money.

But there are confusing exceptions. As Dunphy found out, colonoscopies can go from free to pricey while the patient is under anesthesia.

Breast cancer screenings can cause confusion too. In Florida, Tampa Bay-area small business owner Dawn Thomas, 50, went for a screening mammogram. But she was told by hospital staff that her mammogram would be a diagnostic test - not preventive screening - because a previous mammogram had found something suspicious. (It turned out to be nothing.)

Knowing that would cost her $700, and knowing her doctor had ordered a screening mammogram, Thomas stood her ground.

"Either I get a screening today or I'm putting my clothes back on and I'm leaving," she remembers telling the hospital staff. It worked. Her mammogram was counted as preventive and she got it for free.

"A lot of women ... are getting labeled with that diagnostic code and having to pay year after year for that," Thomas said. "It's a loophole so insurance companies don't have to pay for it."

For parents with several children, costs can pile up with unexpected copays for kids needing shots. Even when copays are inexpensive, they can blemish a patient-doctor relationship. Robin Brassner of Jersey City, N.J., expected her doctor visit to be free. All she wanted was a flu shot. But the doctor charged her a $20 copay.

"He said no one really comes in for just a flu shot. They inevitably mention another ailment, so he charges," Brassner said. As a new patient, she didn't want to start the relationship by complaining, but she left feeling irritated. "Next time, I'll be a little more assertive about it," she said.

How confused are doctors?

"Extremely," said Cheryl Gregg Fahrenholz, an Ohio consultant who works with physicians. It's common for doctors to deal with 200 different insurance plans. And some older plans are exempt.

Should insurance now pay for aspirin? Aspirin to prevent heart disease and stroke is one of the covered services for older patients. But it's unclear whether insurers are supposed to pay only for doctors to tell older patients about aspirin - or whether they're supposed to pay for the aspirin itself, said Dr. Jason Spangler, chief medical officer for the nonpartisan Partnership for Prevention.

Stop-smoking interventions are also supposed to be free. "But what does that mean?" Spangler asked. "Does it mean counseling? Nicotine replacement therapy? What about drugs (that can help smokers quit) like Wellbutrin or Chantix? That hasn't been clearly laid out."

But the greatest source of confusion is colonoscopies, a test for the nation's second leading cancer killer. Doctors use a thin, flexible tube to scan the colon and they can remove precancerous growths called polyps at the same time. The test gets credit for lowering colorectal cancer rates. It's one of several colon cancer screening methods highly recommended for adults ages 50 to 75.

But when a doctor screens and treats at the same time, the patient could get a surprise bill.

"It erodes a trust relationship the patients may have had with their doctors," said Dr. Joel Brill of the American Gastroenterological Association. "We get blamed. And it's not our fault,"

Cindy Holtzman, an insurance agent in Marietta, Ga., is telling clients to check with their insurance plans before a colonoscopy so they know what to expect.

"You could wake up with a $2,000 bill because they find that little bitty polyp," Holtzman said.

Doctors and prevention advocates are asking Congress to revise the law to waive patient costs - including Medicare copays, which can run up to $230 - for a screening colonoscopy where polyps are removed. The American Gastroenterological Association and the American Cancer Society are pushing Congress fix the problem because of the confusion it's causing for patients and doctors.

At least one state is taking action. After complaints piled up in Oregon, insurance regulators now are working with doctors and insurers to make sure patients aren't getting surprise charges when polyps are removed.

Florida's consumer services office also reports complaints about colonoscopies and other preventive care. California insurance broker Bonnie Milani said she's lost count of the complaints she's had about bills clients have received for preventive services.

"'Confusion' is not the word I'd apply to the medical offices producing the bills," Milani said. "The word that comes to mind for me ain't nearly so nice."

When it's working as intended, the new health law encourages more patients to get preventive care. Dr. Yul Ejnes, a Rhode Island physician, said he's personally told patients with high deductible plans about the benefit. They weren't planning to schedule a colonoscopy until they heard it would be free, Ejnes said.

If too many patients get surprise bills, however, that advantage could be lost, said Stephen Finan of the American Cancer Society Cancer Action Network. He said it will take federal or state legislation to fix the colonoscopy loophole.

Dunphy, the Phoenix businessman, recalled how he felt when he got his colonoscopy bill, like something "underhanded" was going on.

"It's the intent of the law is to cover this stuff," Dunphy said. "It really made me angry."



]]> 2011-12-29T13:20:14+00:00 http://www.therochesterdemocrat.com/index.php/weblog/the_champion_of_painkillers/ {summary} Drug News


Dec. 23, 2011, 2:15 p.m.
by Tracy Weber and Charles Ornstein,
ProPublica
(A version of this story ran in the Washington Post)


The head of the Centers for Disease Control and Prevention has declared the overdoses from opioid drugs like OxyContin an "epidemic." And a growing group of experts doubts that they work for long-term pain.

But the pills continue to have an influential champion in the American Pain Foundation, which describes itself as the nation's largest advocacy group for pain patients. Its message: The risk of addiction is overblown, and the drugs are underused.

What the nonprofit doesn't highlight is the money behind that message.

The foundation collected nearly 90 percent of its $5 million funding last year from the drug and medical-device industry -- and closely mirrors its positions, an examination by ProPublica found.

Although the foundation maintains it is sticking up for the needs of millions of suffering patients, records and interviews show that it favors those who want to preserve access to the drugs over those who worry about their risks.

Some of the foundation's board members have extensive financial ties to drugmakers, ProPublica found, and the group has lobbied against federal and state proposals to limit opioid use. Painkiller sales have increased fourfold since 1999, but the foundation argues that pain remains widely undertreated.

The group says industry money has had no effect on its advocacy.

"I'm convinced with every shred of my body that our interest is improving the lives of people affected by pain," said Will Rowe, the foundation's chief executive, "and we want to do that the best way we can."

The problem isn't opioids, Rowe and other group leaders say. It's poorly trained doctors who prescribe them too easily or in excess.

Yet, critics say the Baltimore-based foundation is making it harder to address a major public-health problem.

"If you were a drug company, wouldn't it be smart to make it look like you had a patient-oriented group?" said Dr. Gary Franklin, a Washington state official who tussled with the foundation over new restrictions on high-dose painkillers.

Its funding makes the group "one and the same" with the pain industry, Franklin said.

In stories this year, ProPublica has detailed the close entanglements between pharmaceutical companies and groups representing doctors. Reporting showed that the positions of societies representing specialty physicians often reflected the views of their major funders.

The American Pain Foundation falls into a different category -- health advocacy. It harnesses the power of patient stories to sway politicians, state medical boards, judges and government health regulators, emphasizing that it represents grassroots voices.

ProPublica's review found that the foundation's guides for patients, journalists and policymakers play down the risks associated with opioids and exaggerate their benefits. Some of the foundation's materials on the drugs include statements that are misleading or based on scant or disputed research.

The group has intervened in court cases in ways that appear to counter its stated mission. In one example, it sided with Purdue Pharma, its longtime funder, to block a 2001 class-action case filed by Ohio patients who had become addicted to or dependent on the company's blockbuster painkiller, OxyContin.

And the foundation mobilizes patients to send "outraged" email messages to news organizations that run stories it believes reinforce "stigmas and stereotypes" about the risks of pain medication.

The group's board includes some patients but also doctors who are paid to speak and consult for drug companies, a researcher whose clinic has relied on their funding for survival and a public-relations executive whose firm represents them.

Last year, one board member was the lead author of a study about a Cephalon drug. Cephalon sponsored the study, and its employees were co-authors. The study found that the drug, Fentora, was "generally safe and well-tolerated" in non-cancer patients even though it is only approved for severe cancer pain.

Dr. Andrew Kolodny, a New York psychiatrist who heads Physicians for Responsible Opioid Prescribing, said the foundation has built credibility with politicians and regulators who may not be aware of the extensive industry ties.

"I don't think they realize that in many ways the American Pain Foundation is a front for opioid manufacturers," Kolodny said.

Rowe, however, said it can be hard for critics to understand the mindset of patients whose pain is so severe they are willing to risk serious side effects to gain relief.

"Policymakers can go to bed at night and say, 'Well, I protected society,'" by restricting access to a risky painkiller," he said. "The person with pain or the person with cancer could say, 'You know, I'm sorry. I'm living with this, and I want to take this chance.'"

'The System Is Awash in Opioids'

In the late 1980s and early '90s, physicians who cared for pain patients excitedly embraced opioids as a low-risk treatment for suffering.

Derived from the opium plant, opioids reduce the perception of pain by attaching to opioid receptors in the brain, spinal cord and elsewhere in the body.

"We bought into this idea that opioids would be effective and that the risk of addiction would be low," said Dr. Jane Ballantyne, a longtime pain expert and a professor at the University of Washington.

But along the way, pain doctors split. Some, like Ballantyne, began decrying the increasingly widespread use of opioids and questioned whether the drugs worked. Others, like the foundation's leaders, said the drugs were being unfairly maligned, making pain patients feel like criminals and discouraging doctors from prescribing them.

Despite the debate, sales of the drugs have skyrocketed.

Last year, $8.5 billion worth of narcotic painkillers were sold in the United States, according to the prescription-tracking company IMS Health. Enough of the drugs were prescribed last year to "medicate every American adult around the clock for a month," the CDC said.

"Right now, the system is awash in opioids, dangerous drugs that got people hooked and keep them hooked," said CDC Director Thomas Frieden in a recent news briefing.

Some of the pills have become household names: Vicodin, Percocet, OxyContin. On its own, OxyContin, an extended-release painkiller, accounted for $3.1 billion in sales last year, up from $752 million in 2006, according to IMS Health.

There's little dispute that many people endure chronic pain. In the past, many doctors, especially those providing primary care, ignored pain as a condition that warranted its own treatment.

A report from the prestigious Institute of Medicine last summer said 116 million American adults suffer from chronic pain. The report also cited legal and regulatory barriers to opioids, especially for cancer and end-of-life pain. The findings are lauded by the foundation as underscoring the concern about undertreatment.

In an email to ProPublica, however, the report's chairman said the study panel took a broad look at chronic pain and didn't examine the use of opioids with "rigor or detail."

"It does seem like the issue of opioid use is worthy of a separate study," wrote Dr. Philip A. Pizzo, dean of Stanford University's medical school.

Guides Offer Reassurance About Pain Drugs

The American Pain Foundation's website offers publications for patients, policymakers and even journalists. Each depicts the benefits of opioids, and each is underwritten by the makers of those drugs.

Its patient guide, paid for by four companies, discusses several treatments for pain. It says such pain relievers as aspirin, ibuprofen and naproxen commonly cause gastrointestinal bleeding or ulcers, delay blood clotting, decrease kidney function and may increase the risk of stroke or heart attack. And it warns patients to use these pain pills at the lowest dose and stop them unless clearly needed.

The side effects of opioids, on the other hand, are minor, and most go away "after a few days," the foundation's guide says. The underuse of opioids, it says, "has been responsible for much unnecessary suffering."

Patients, it says, shouldn't worry if they need more of a drug. They are not developing an addiction.

"Many times when a person needs a larger dose of a drug," the guide says, "it's because their pain is worse or the problem causing their pain has changed."

Another guide, written for journalists and supported by Alpharma Pharmaceuticals, likewise is reassuring. It notes in at least five places that the risk of opioid addiction is low, and it references a 1996 article in Scientific American, saying fewer than 1 percent of children treated with opioids become addicted.

But the cited article does not include this statistic or deal with addiction in children.

"I would much prefer that they would put in there something that could be substantiated by a real reference," said Dr. Leonard Paulozzi, a CDC medical epidemiologist specializing in drug overdoses. "That would present a much less rosy picture of the risk."

A recent report by the National Institute on Drug Abuse said estimates of addiction among chronic pain patients using opioids range from 3 percent to as high as 40 percent.

One Foundation-related publication this year provided a case study of how physicians could convince patients that the drugs are not addictive.

In an e-newsletter paid for by a drug company, Florida family physician Louis Kuritzky summed up the advice he'd give to a patient with knee pain: "We have learned that when patients have important pain problems like you do, they can use such medications successfully over the long term without any major risk of addiction."

This advice is contradicted by a respected medical review organization that looked at research on the use of opioids for osteoarthritis of the knee or hip. The Cochrane Collaboration concluded that "the small to moderate" benefits of opioids "are outweighed by large increases in the risk of adverse events" and the drugs should not be routinely used.

Kuritzky said he had not read the Cochrane review but believes that the downside of opioids is "very, very small" based on his experience with his patients.

"There are many issues where you will see wise men and women differ about the right answer to a difficult and important question," he said.

Rowe, the foundation's chief executive, acknowledged that some of its publications need updating. He pointed to additional materials on the group's new PainSAFE website, which include a broader description of the risks. But the foundation continues to post outdated guides and even refers to them in newer materials.

And while the PainSAFE site discusses the risks more completely, it is based on the assumption that the drugs have proven to work well for chronic pain sufferers. The site says studies have shown opioids improve daily function and quality of life for such patients. In contrast, a new guide by New York City's Department of Health and Mental Hygiene says there is "insufficient evidence" that "pain relief is sustained or function improves."

Dr. Lewis Nelson, chairman of the federal Food and Drug Administration's Drug Safety and Risk Management Advisory Committee, said he believes the foundation's guides can't help but be biased.

"If you're taking drug-company money and you're working as an advocacy group for patients, I think by definition you're biased," said Nelson, an emergency room physician in New York. "I take everything they say with a grain of salt."

Fighting in Court for Painkiller Access

The foundation doesn't just offer advice about opioids; it takes its arguments into court.

In 2005, it filed a friend-of-the-court brief in the U.S. Fourth Circuit Court of Appeals in support of Dr. William Hurwitz, a pain doctor in Virginia who had been convicted on 50 counts of drug trafficking.

The doctor had been accused of prescribing a single patient as many as 1,600 Roxicodone pain pills in one day. Hurwitz allegedly had prescribed that patient alone more than 500,000 pills between July 1999 and October 2002.

The pain foundation and its allies argued that the jury instructions in the case didn't distinguish between criminal behavior and mistakes by a well-intentioned physician. "It is not drug dealing to prescribe opioids to patients that might be 'suspected' addicts or substance abusers," the foundation and two other groups wrote in a brief.

Rowe said the foundation intervened in the case on principle, fearing the drugs would be "demonized." The appeals court threw out the conviction, but Hurwitz was retried and convicted on 16 counts of trafficking.

Years earlier, the foundation opposed several pain patients who had sued Purdue Pharma in an Ohio county court for allegedly obscuring the risks of OxyContin.

The foundation filed a friend-of-the-court brief backing Purdue, arguing that the health of all pain patients would be harmed if the class-action lawsuit went forward because doctors would become fearful of prescribing opioids.

Ohio was plagued by "opiophobia" according to a brief co-authored by the foundation and two smaller pain nonprofits. "Consequently many, if not most, of the state's residents had been deprived of adequate pain care," it said.

The Ohio Supreme Court decided in 2004 not to allow a class action.

In a separate federal case in 2007, Purdue pleaded guilty to misbranding OxyContin "in an effort to mislead and defraud physicians and consumers," according to a statement from prosecutors. The company agreed to pay $600 million in penalties. Three top officials also pleaded guilty to misdemeanors and agreed to pay $34.5 million.

Two months after the conviction, however, then-foundation chairman Dr. James Campbell praised Purdue in a statement to a U.S. Senate committee.

"I believe Purdue and its management deserve recognition for their contribution to the welfare of these many patients," Campbell wrote. Prosecuting the executives, he wrote, sent a "chilling message to those who dare to develop high-risk drugs for important diseases."

Campbell mentioned his foundation role in his remarks. Rowe said the former board chairman was not speaking for the group, and stressed that strict rules keep funders from influencing its work. The foundation is working to diversify its support, Rowe and others said.

Nevertheless, the group often finds itself on the same side as drugmakers in state and federal debates over how to regulate painkillers.

In 2009, the FDA suggested changes to address concerns about the risks of long-acting opioids, recommending that physicians and pharmacists be certified to ensure they had been educated about those risks.

Although foundation officials blame poorly educated physicians for the growing problems with opioids, the officials joined with other pain groups and drugmakers to assail the plan.

The FDA backed off key elements of its proposal last year and said doctors could voluntarily attend courses about the risks.

That move was criticized by an FDA advisory committee, which voted overwhelmingly that it wasn't enough to stem the tide of overdose deaths.

"When you look at 14,000 people dying on an annual basis, that's more than we've lost in Iraq and Afghanistan since 2001 in active duty," Dr. Mori Krantz, an advisory panel member and director of the prevention center at the University of Colorado in Denver, said during the meeting.

Little Evidence That Narcotics Work for Chronic Pain

Missing from the American Pain Foundation literature is any suggestion that the drugs don't work for many chronic pain sufferers.

Recent editorials in medical journals and scientific reviews cite little evidence of long-term benefit.

Most of the clinical trials for opioids to treat chronic pain "were small, lasted less than 16 weeks and excluded patients with a history of substance abuse, psychiatric illness and depression, who are at increased risk for opioid misuse and abuse," three physicians wrote in an editorial this year in the Archives of Internal Medicine.

"How can a therapy be considered if there's no evidence that it works and there's evidence of lots of side effects?" Dr. Mitchell Katz, one of the authors and director of the Los Angeles County Department of Health Services, said in an interview.

Rowe said he knows plenty of patients for whom the drugs work, "and their lives are together because they use them."

The foundation board's chairman and president, Dr. Scott Fishman, is stepping down at the end of the month. In a statement to ProPublica, he said his views have evolved and that he now believes opioids are both overused and addictive. But he defended the group.

"I have not always agreed with APF positions and have had disagreements with some APF leaders and patient advocates about many issues in pain management, including the appropriate place of chronic opioid therapy," wrote Fishman, chief of pain medicine at University of California, Davis.

"Nonetheless, I have always believed that patients in pain in the United States need strong patient advocacy, which APF has offered."


]]> 2011-12-29T12:35:11+00:00 http://www.therochesterdemocrat.com/index.php/weblog/france_recommends_removal_of_risky_breast_implants/ {summary} Implants








PARIS (AP) - Tens of thousands of women with risky, French-made breast implants should have them removed at the state's expense, France's health minister recommended Friday, in an unprecedented move that could have implications across Europe and South America.

Xavier Bertrand said the mass removals were "preventive" and not urgent, and French health officials said analyses so far have found no link between the pre-filled silicone gel implants and nine cases of cancer among women implanted with them.

But Bertrand, in a statement, cited an unusually high risk that the implants could rupture and leak a questionable type of silicone gel into the wearer's body.

Health authorities in Britain - where even more women have the implants than in France - said Friday that for now they see no reason to take similar action.

Questions remain about the logistics and final costs of the removals. Francois Godineau, a top official in the French national health service, estimated it could deplete French government coffers by euro60 million ($78 million) at a time when the country is teetering on a brink of a new recession and struggling to tame state debt.

Investigators say the company Poly Implant Prothese used cheaper industrial silicone for the implants instead of medical silicone to save money. The implants were pulled from the market last year and the company is being liquidated.

"As a preventive measure not of an urgent nature, (French authorities) recommend that the removal of these implants, even those not showing signs of deterioration, be proposed," the statement said. It added that the costs of removal would be footed by France's national health care system - presumably solely for French patients.

One reason for the drastic measure is the uncertainty about the contents of the silicone gel used and the risks it poses to internal organs. Also, standard mammograms and ultrasounds do not always indicate that an implant has ruptured, and many women may be walking around unknowingly with burst implants.

Some 30,000 of women in France, and tens of thousands more in Britain, Italy, Spain, Portugal and other countries in Europe and South America have had implants made by PIP. The implants in question were not sold in the U.S.

All breast implants are subject to rupture, especially as they get older, and patients are meant to be informed of the risks before getting them put in.

But "these implants have a particular fragility" and appear to pose risks of rupture earlier in their life spans than other implants, Jean-Claude Ghislain of French health agency AFSSAPS, told a news conference Friday.

Removal of the implants can require general anesthesia and other risks associated with major surgery. The government recommendations say women who don't want to get them removed should be examined every six months.

Leading French plastic surgeons had been urging the government to act. The death last month of a woman who had the implants and developed a rare cancer catalyzed worries.

Annie Mesnil, who had a PIP implant to replace a breast removed after cancer in 1999, said she was relieved that the Health Ministry "accepts the idea that there is a potential danger."

But, she added, "It's not enough. They will pay for the removal of the implants, but they will not pay for the replacements."

France's state health care system normally pays for implants for medical reasons, but not for cosmetic implants. About 80 percent of those with the PIP silicone implants have them for esthetic reasons.

After the PIP product was recalled last year, a mammogram and ultrasound did not reveal any problem with Mesnil's implant. But Mesnil, 62, had it removed anyway, at her own expense, out of fear. When her surgeon took it out and studied it, "he discovered it had already burst," she said.

Chantal Guerin, a 46-year-old accountant and mother of three, had her left breast removed after cancer and had PIP implants put in both breasts. In 2010, she developed cancer in her right breast.

"One cannot directly incriminate the implant, since there is no scientific proof," she said in an interview. "But we have the right to ask ourselves a lot of questions, because there is a great amount of physical pain involved."

She insisted that women who have implants for cosmetic reasons should also be protected by government health care.

Following the French announcement, Britain's Medicines and Healthcare Products Regulatory Agency said it was still not recommending that women in Britain have the implants removed. The agency says up to 40,000 women in Britain may have had the implants.

"We recognize the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France," it said in a statement.

"We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence."

In the U.S., concerns about silicone gel implants in general led to a 14-year ban on their use. Silicone implants were brought back to the market in the U.S. 2006 after research ruled out cancer, lupus and some other concerns.


]]> 2011-12-23T14:23:52+00:00 http://www.therochesterdemocrat.com/index.php/weblog/wal-mart_pulls_formula_after_baby_dies_in_missouri/ {summary} Child Health, Products, Recalls







COLUMBIA, Mo. (AP) - Wal-Mart and health officials awaited tests Thursday on a batch of powdered infant formula that was removed from more than 3,000 stores nationwide after a Missouri newborn who consumed it apparently died from a rare infection.

The source of the bacteria that caused the infection has not been determined, but it occurs naturally in the environment and in plants such as wheat and rice. The most worrisome appearances have been in dried milk and powdered formula, which is why manufacturers routinely test for the germs.

Wal-Mart pulled the Enfamil Newborn formula from shelves as a precaution following the death of little Avery Cornett in the southern Missouri town of Lebanon.

The formula has not been recalled, and the manufacturer said tests showed the batch was negative for the bacteria before it was shipped. Additional tests were under way.

"We decided it was best to remove the product until we learn more," Wal-Mart spokeswoman Dianna Gee said. "It could be returned to the shelves."

Customers who bought formula in 12.5-ounce cans with the lot number ZP1K7G have the option of returning them for a refund or exchange, Gee said.

The product is not exclusive to Wal-Mart. The manufacturer, Mead Johnson Nutrition, declined to answer questions about whether formula from that batch was distributed to other stores.

"We're highly confident in the safety and quality of our products," said Christopher Perille, a spokesman for the company based in the Chicago suburb of Glenview.

A second infant fell ill late last month after consuming several different types of powdered baby formula, but that child recovered, health officials said.

Powdered infant formula is not sterile, and experts have said there are not adequate methods to completely remove or kill all bacteria that might creep into formula before or during production.

Preliminary hospital tests indicated that Avery died of a rare infection caused by bacteria known as Cronobacter sakazakii. The infection can be treated with antibiotics, but it's deemed extremely dangerous to babies less than 1 month old and those born premature.

The bacteria are "pervasive in the environment," Perille said. "There's a whole range of potential sources on how this infection may have got started."

A spokeswoman for the Food and Drug Administration said the agency is investigating the death, along with the Centers for Disease Control and the Missouri Department of Health. Investigators have collected samples from the family and are testing unopened formula purchased at stores.

Siobhan Delancey said the FDA gets four to six reports a year of infant infections related to formula and has not found a powder that tested positive since 2002.

The FDA is also investigating the other case of illness, which involved a baby from Illinois whose case was reported in neighboring Missouri. But the agency does not believe there is any connection between the two, Delancey said.

Public health investigators will look at the formula itself, as well as the water used in preparing it and at anything else the baby might have ingested, Perille said.

Only two to three cases a year are reported. New Mexico saw two in 2008, including one infant who died and another who suffered severe brain damage. A Tennessee infant died in 2001 after being infected.

It could be several days before test results are available.

The family submitted two types of infant formula for testing - the powdered version and a pre-sterilized, ready-to-eat liquid - as well as the distilled water used to prepare the powdered product.

"We're just trying to test anything that was consumed by the baby," Laclede County Health Director Charla Baker said.

Avery was taken to a pediatrician Dec. 15 - a week after he was born - after showing signs of stomach pain and lethargy. When the pain persisted the next day, his parents took him to an emergency room.

He died Sunday at a hospital in Springfield after being removed from life support.

The Missouri Department of Health advised parents to follow safety guidelines for preparing powdered infant formula, including washing hands, sterilizing all feeding equipment in hot, soapy water and preparing enough formula for only one feeding at a time.

A flood of calls from worried parents prompted Missouri officials to clarify that the formula pulled by Wal-Mart is not being provided to participants in the Women, Infants and Children federal program for low-income parents.


]]> 2011-12-23T01:23:59+00:00 http://www.therochesterdemocrat.com/index.php/weblog/group_urges_govt_to_strictly_limit_chimp_research/ {summary} Research







WASHINGTON (AP) - Chimpanzees should hardly ever be used for medical research, a prestigious scientific group told the government Thursday - advice that means days in the laboratory may be numbered for humans' closest relatives.

The Institute of Medicine stopped short of recommending the outright ban that animal rights activists had pushed. Instead, it urged strict limits that would make invasive experiments with chimps essentially a last resort, saying today's more advanced research tools mean the primates' use only rarely will be necessary enough to outweigh the moral costs.

Chimp research already was dwindling fast as scientists turned to less costly and ethically charged alternatives. The government agency in charge of it - the National Institutes of Health - called the new recommendations "scientifically well-founded" and signaled that it would make some changes.

"While operational details will need to be worked out, NIH intends to adopt the panel's general conclusions," said Dr. Francis Collins, the NIH's director.

These apes' genetic similarity to people has long caused a quandary. It's what has made them so valuable to scientists for nearly a century. They were vital in creating a vaccine for hepatitis B, for example, and even were shot into space to make sure the trip wouldn't kill the astronauts next in line.

But that close relationship also has had animal rights groups arguing that using chimps for biomedical research is unethical, even cruel.

"We understand and feel compelled by the moral cost of using chimpanzees in research," said bioethicist Jeffrey Kahn of Johns Hopkins University, who chaired the Institute of Medicine panel. "We have established criteria that will set the bar quite high for justification of the use of chimpanzees."

For biomedical research - testing new drugs or giving the animal a disease - that means using chimps only if studies cannot be done on other animals or people themselves, and if foregoing the chimp studies would hinder progress against life-threatening or other debilitating diseases.

The panel advised the government to limit use of chimps in behavioral research as well, saying such studies must provide insights into the brain and behavior that otherwise are unattainable - and use techniques that minimize any pain or distress.

The U.S. is one of only two countries known to still conduct medical research with chimpanzees; the other is Gabon, in Africa. The European Union essentially banned such research last year.

Here, too, the practice is dwindling fast. The Institute of Medicine's investigation found over the past 10 years, the NIH has paid for just 110 projects of any type that involved chimps. There are not quite 1,000 chimps available for medical research in the country. While it's impossible to say how many have been used in privately funded pharmaceutical research, the industry is shifting to higher-tech and less costly research methods. One drug company, GlaxoSmithKline, adopted an official policy ending its use of great apes, including chimpanzees, in research.

Thursday's report was triggered by an uproar over the fate of 186 semi-retired research chimps that the NIH, to save money, last year planned to move from a New Mexico facility to an active research lab in Texas.


]]> 2011-12-15T17:53:40+00:00 http://www.therochesterdemocrat.com/index.php/weblog/he_finds_viruses_captivating/ {summary} Virus



By Karen Weintraub
Boston Globe
December 11, 2011


“A lot of our major health problems involve viruses that didn’t make people sick all that long ago,” said Carl Zimmer, a science writer who is author of “Planet of Viruses.” “If you went back a century, there was no HIV.”

Q. What fascinates you about viruses?

A. Viruses in a way really rule the world, we just don’t know it. They’re the most abundant form of life by far. They’re everywhere: they’re in the oceans, they’re in the soil, they’re in the air, they’re inside of us - even when we’re healthy. And they’ve been around since the beginning of life. Their existence and ours are really intertwined.

Q. How many are in our bodies?

A. By one estimate, there are 4 trillion viruses in your body. They’re mostly viruses that infect the bacteria that are also living inside of you. They’re kind of like predators in your ecosystem - they are keeping different species in check. We also have viruses in our own genome, which is pretty mind-blowing. There are maybe 100,000 pieces of our DNA that came from viruses.

Q. And there are some we can’t live without?

A. There’s a virus gene that makes a protein that is essential for placentas to attach to the uterus wall. If that gene is not there, there’s no way the placenta can form. So, it’s literally true that none of us would be here without this in our genome.

Q. Of course, viruses make us sick, too.

A. A lot of our major health problems involve viruses that didn’t make people sick all that long ago. If you went back a century, there was no HIV [the virus that causes AIDS]. What a lot of scientists are doing is trying to find a way to predict what is the next virus that is going to jump from animals to us?

Q. Has your research into viruses made you paranoid about them?

A. I don’t think I’m paranoid. Sometimes I feel very fatalistic. Sometimes you just think oh, gosh, something like the movie “12 Monkeys’’ - you start to think, maybe that could happen. I think that one’s a little extreme, but still, there’s some serious trouble ahead, I’m sure.

Q. A lot of people seem to confuse viruses and bacteria. Can you explain the difference.

A. Bacteria are a lot more like us - they’ve got lots of DNA in them, lots of proteins inside of them. They can feed, they can grow, they can divide. Most viruses are just protein cells with just a few genes inside. All they can do is insert their genes and proteins into a cell and force that cell to make new viruses. They’re not quite alive in the sense that bacteria or we are alive.

Q. That’s why they’re harder to treat with medications?

A. There aren’t many good antivirals. There’s not one for the cold. Viruses change quickly - they mutate a lot. If you get sick with a cold, your body starts producing lots of new cold viruses. Every single spot in the cold viruses’ genes may mutate. You’re producing millions or billions of viruses. That means there’s this fantastic opportunity to evolve protection against the drugs we try to make for them. It also means that drugs that work against one strain may not work against another strain. There aren’t a whole lot of targets to hit on a virus.

Q. But scientists are getting better at fighting viruses?

A. I think there’s reason to be optimistic. It’s possible that scientists may need to rethink how they attack viruses to really come up with an effective, new generation of antivirals, but there are people who are exploring that now.


]]> 2011-12-12T13:49:47+00:00 http://www.therochesterdemocrat.com/index.php/weblog/study_bone_drug_boosts_breast_cancer_survival/ {summary} Cancer





SAN ANTONIO – Doctors were mostly hoping to prevent complications and relapses when they gave young women a medicine to keep their bones strong during breast cancer treatment. Seven years later, they found it did more than that: The bone drug improved survival, as much as many chemotherapies do.

The study found a 37 percent lower risk of death among women who received the bone drug, Zometa. In absolute terms, it meant that 4 to 5 more women out of every 100 were alive seven years later.

It's especially impressive considering that the women took the drug, given as an infusion every six months, for only three years.

"The benefit persists" long after treatment ends, said study leader Dr. Michael Gnant of Austria's Medical University of Vienna. He presented the research this week at the San Antonio Breast Cancer Symposium.

Zometa (zow-MAY-tuh) should now be offered to all patients like those in this study — younger women forced into early menopause by hormone-blocking cancer treatments, some specialists said.

"It's a new standard of care," said Dr. James Ingle, a Mayo Clinic breast specialist who had no role in the study.

Bone drugs called bisphosphonates — sold as Fosamax, Boniva and Actonel — have long been sold for treating osteoporosis. Those are daily pills. Zometa, made by the Swiss company Novartis AG, is given intravenously to treat cancer that has spread to the bone.

Hope that it could do more grew in 2008, when Gnant reported that it lowered the risk of a cancer recurrence in a study of 1,800 premenopausal women with early-stage breast cancer. All had surgery followed by hormone blockers, and half also received Zometa.

Now, with seven years of follow-up, researchers see that Zometa not only helped keep cancer from coming back, but also improved survival. There were 33 deaths among women given the bone drug and 49 among those not treated with it.

That magnitude of benefit is comparable to many chemotherapy treatments. Researchers think because Zometa strengthens bones, it's tougher for cancer to spread there and the drug may also have direct effects against circulating cancer cells or microscopic tumors.

Zometa's side effects were mostly fever and bone and joint pain, and doctors saw no cases of jawbone decay, a serious problem long linked to bisphosphonates. Zometa costs more than $1,000 in the U.S. and about half as much in Europe, though the price may drop when its U.S. patent expires in 2013. Novartis helped pay for the study and Gnant consults for the company.

The bone drug proved disappointing though in a large study last year in postmenopausal women, who account for three-fourths of all breast cancers. But there was a glimmer of hope in the oldest patients.

"They benefitted substantially as long as they were well past menopause," said Dr. Peter Ravdin, director of the breast cancer program at the UT Health Science Center in San Antonio, who also had no role in the research.

Other studies reported at the conference this week strengthen the view that Zometa works best in women with little estrogen. A consistent picture is emerging, Ravdin said.

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


Online:

Cancer conference: http://www.sabcs.org


]]> 2011-12-12T13:30:26+00:00 http://www.therochesterdemocrat.com/index.php/weblog/vaccine_developed_against_ebola_virus/ {summary} Immunization




6 December 2011
by Jennifer Carpenter Science reporter, BBC News


Scientists have developed a vaccine that protects mice against a deadly form of the Ebola virus.

First identified in 1976, Ebola fever kills more than 90% of the people it infects.

The researchers say that this is the first Ebola vaccine to remain viable long-term and can therefore be successfully stockpiled.

The results are reported in the journal Proceedings of National Academy of Sciences.

Ebola is transmitted via bodily fluids, and can become airborn. Sufferers experience nausea, vomiting, internal bleeding and organ failure before they die.

Although few people contract Ebola each year, its effects are so swift and devastating that it is often feared that it could be used against humans in an act of terroism.

All previously developed vaccines have relied on injecting intact, but crippled, viral particles into the body.

Long-term storage tends to damage the virus, paralysing the vaccine's effectiveness.

The new vaccine contains a synthetic viral protein, which prompts the immune system to better recognise the Ebola virus, and is much more stable when stored long-term.

The vaccine protects 80% of the mice injected with the deadly strain, and survives being "dried down and frozen," said biotechnologist Charles Arntzen from Arizona State University who was involved in its development.


]]> 2011-12-06T20:44:53+00:00 http://www.therochesterdemocrat.com/index.php/weblog/flu_vaccinations_still_recommended_peak_typically_hits_early_in_year/ {summary} Flu



By Lisa Pevtzow,
Chicago Tribune
December 7, 2011


As the influenza season heads in, Carol Baker, who chairs the National Foundation for Infectious Diseases' Childhood Influenza Immunization Coalition, answers some common questions about the flu vaccine. Baker is a professor of pediatrics, molecular virology and microbiology at Baylor College of Medicine in Houston.

Q. What is the flu vaccine and who should receive it?

A. The influenza vaccine protects against three different strains of the virus that are determined each year by flu trends in the Southern Hemisphere six months previously. This year's vaccine is identical to last year's. But even if you got the flu shot last year, it's still important to get one this year because the vaccine doesn't last more than a year, at most.

In general, everyone 6 months of age and older should receive the vaccine. It's especially important that the very old, the very young, people with compromised immune systems and pregnant women be vaccinated, because they are the populations more likely to develop serious complications. During the H1N1 flu pandemic in 2009, 5 percent of the deaths from the outbreak were pregnant women. Immunity passes from the mother to the baby in utero and protects them against the flu until they are old enough to be vaccinated. Because infants can't be immunized until they are 6 months, they should be surrounded by vaccinated people, just as cancer patients and other especially vulnerable people should be surrounded by people who are vaccinated.

Q. How effective is the flu vaccine?

A. Unfortunately, getting vaccinated won't guarantee you won't get the flu, but it greatly lessens the chance. Even if the vaccine is a good match to the flu strains that year, its effectiveness is just 70 percent. Everyone in the medical world agrees we need a better vaccine that covers all strains and lasts a lot longer. Scientists around the world are working on developing a universal vaccine that potentially would work like the measles vaccine — two doses and you're protected for life — but this is five to seven years off or longer.

Q. What is new this year?

A. The Fluzone high-dose vaccine, which is four times stronger than the standard dose, is being offered to adults 65 and older. The standard vaccine does not work as well in older people and young children, and we hope that the higher dose of antigen in this vaccine will strengthen their immune response.

For people who avoid the flu vaccine because they are afraid of needles, the intradermal vaccine uses an ultrafine needle to inject the flu vaccine directly into the skin, instead of the muscle. The needle is 90 percent smaller. Only healthy people, aged 18 to 54, can receive the intradermal vaccine.

This year, children under 9 who were fully vaccinated last year only need one dose of the flu vaccine, because it is the same as last year. Normally, children under 9 receive two doses. Children who were not vaccinated last year should receive two doses, as usual. Also, the American Academy of Pediatrics recommends that children with minor allergies to eggs receive the vaccine. Previously, children with egg allergies were not vaccinated. Parents of children with more serious egg allergies should talk to their health care professionals.

Q. What are some of the myths about the flu vaccine?

A. The oldest and worst myth I've heard — and I've even heard nurses say this — is, "I got the vaccine and it caused the flu." The shot is made up of dead virus that can't give anyone the flu, and even the live virus present in the nasal spray flu vaccine has been weakened so much that it won't cause any symptoms. It takes two weeks for the flu shot to become effective. That's why I tell people to get flu vaccine early. The flu usually starts with winter and peaks in February. If the vaccine is available in September, get it in September.

I also hear a lot of people say: "My child is healthy, so he doesn't need to be vaccinated. Only children with weakened immune symptoms really need the flu shot." In reality, about 150 children died last year from the flu, and about half of them were previously healthy. Likewise, about 20,000 children were hospitalized due to complications from the flu and about half of them were previously healthy.

Q. What can you do if you get the flu?

A. Remember, it's very contagious, so use cough and hand hygiene to keep it from spreading. Prescription drugs, like Tamiflu, are effective in shortening the duration of the illness, but you need to begin taking them within 36 hours of the onset of symptoms. People really shouldn't go to work. They're not productive and can make everyone else sick. The best thing, though, is to try to prevent the flu by making it a habit to get vaccinated every year.


]]> 2011-12-06T13:42:26+00:00 http://www.therochesterdemocrat.com/index.php/weblog/china_prepares_for_big_entry_into_vaccine_market/ {summary} Drug News, Immunization







BEIJING (AP) - The world should get ready for a new Made in China product - vaccines.

China's vaccine makers are gearing up over the next few years to push exports in a move that should lower costs of lifesaving immunizations for the world's poor and provide major new competition for the big Western pharmaceutical companies.

However, it may take some time before some parts of the world are ready to embrace Chinese products when safety is as sensitive an issue as it is with vaccines - especially given the food, drug and other scandals the country has seen.

Still, China's entry into this market will be a "game changer," said Nina Schwalbe, head of policy at the GAVI Alliance, which buys vaccines for 50 million children a year worldwide.

"We are really enthusiastic about the potential entry of Chinese vaccine manufacturers," she said.

China's vaccine-making prowess captured world attention in 2009 when one of its companies developed the first effective vaccine against swine flu - in just 87 days - as the new virus swept the globe. In the past, new vaccine developments had usually been won by the U.S. and Europe.

Then, this past March the World Health Organization announced that China's drug safety authority meets international standards for vaccine regulation. It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.

"China is a vaccine-producing power" with more than 30 companies that have an annual production capacity of nearly 1 billion doses - the largest in the world, the country's State Food and Drug Administration told The Associated Press.

But more needs to be done to build confidence in Chinese vaccines overseas, said Helen Yang of Sinovac, the NASDAQ-listed Chinese biotech firm that rapidly developed the H1N1 swine flu vaccine. "We think the main obstacle is that we have the name of 'made in China' still. That is an issue."

China's food and drug safety record in recent years hardly inspires confidence: in 2007, Chinese cough syrup killed 93 people in Central America; one year later, contaminated blood thinner led to dozens of deaths in the United States while tainted milk powder poisoned hundreds of thousands of Chinese babies and killed six.

The government has since imposed more regulations, stricter inspections and heavier punishments for violators. Perhaps because of that, regulators routinely crack down on counterfeit and substandard drugmaking.

While welcoming WHO's approval of China's drug safety authority, one expert said it takes more than a regulatory agency to keep drugmakers from cutting corners or producing fakes.

"In the U.S., we have supporting institutions such as the market economy, democracy, media monitoring, civil society, as well as a well-developed business ethics code, but these are all still pretty much absent in China," said Yanzhong Huang, a China health expert at the Council on Foreign Relations. "For China, the challenge is much greater in building a strong, robust regulative capacity."

Last year, a Chinese newspaper report linked improperly stored vaccines to four children's deaths in northern Shanxi province, raising nationwide concern. The Health Ministry said the vaccines did not cause the deaths, but some remained skeptical.

Meanwhile, Chinese researchers reported in the New England Journal of Medicine earlier this year that a pandemic flu vaccine given to 90 million people in 2009 was safe.

WHO's medical officer for immunization, Dr. Yvan Hutin, said WHO's approval of the Chinese drug regulatory agency is not "a blank check." Each vaccine will be evaluated rigorously, with WHO and Chinese inspectors given access to vaccine plants on top of other safety checks, he said.

Vaccines have historically been a touchy subject in the Western world, rife with safety concerns and conspiracy theories. Worries about vaccine safety resurfaced in the late 1990s triggered by debate over a claimed association between the vaccine for measles, mumps and rubella and autism. The claim was later discredited.

For China, the next few years will be crucial, as biotech companies upgrade their facilities and improve procedures to meet the safety and quality standards - a process that is expected to be costly and challenging. Then they will submit vaccines to the U.N. health agency for approval, which could take a couple of years.

First up is likely to be a homegrown vaccine for Japanese encephalitis, a mosquito-borne disease that can cause seizures, paralysis and death. The vaccine has been used for two decades in China with fewer side effects than other versions. Its manufacturer expects WHO approval for it in about a year. Also in the works are vaccines for polio and diseases that are the top two killers of children - pneumonia and rotavirus, which causes diarrhea.

Vaccines also are a significant part of a $300 million partnership with the Bill & Melinda Gates Foundation for the development of new health and farming products for poor countries.

China's entry into this field is important because one child dies every 20 seconds from vaccine-preventable diseases each year. UNICEF, the children's agency and the world's biggest buyer of vaccines, has been in talks with Chinese companies, said its supply director Shanelle Hall. The fund provides vaccines to nearly 60 percent of the world's children, and last year spent about $757 million.

Worldwide, vaccine sales last year grew 14 percent to $25.3 billion, according to healthcare market research firm Kalorama Information, as drugmakers which face intensifying competition from generic drugs now see vaccines as key areas of growth, particularly in Latin America, China and India.

China's vaccine makers, some of whom already export in small amounts, are confident they will soon become big players in the field.

"I personally predict that in the next five to 10 years, China will become a very important vaccine manufacture base in the world," said Wu Yonglin, vice president of the state-owned China National Biotec Group, the country's largest biological products maker that has been producing China's encephalitis vaccine since 1989.

CNBG will invest more than 10 billion yuan ($1.5 billion) between now and 2015 to improve its facilities and systems to meet WHO requirements, Wu said. The company also intends to submit vaccines to fight rotavirus, which kills half a million kids annually, and polio for WHO approval.

Smaller, private companies are also positioning themselves for the global market.

Sinovac is now testing a new vaccine for enterovirus 71, which causes severe hand, foot and mouth disease among children in China and other Asian countries. It is also preparing for clinical trials on a pneumococcal vaccine Yang says could rival Pfizer's Prevnar, which was the top-selling vaccine worldwide last year with sales of about $3.7 billion.

Pneumococcal disease causes meningitis, pneumonia and ear infection.

"In the short term, everyone sees the exporting opportunities, because outside of China the entire vaccine market still seems to be monopolized by a few Big Pharma (companies)," Yang said.

The entry of Chinese companies is expected to further pressure Western pharmaceutical companies to lower prices. Earlier this year, UNICEF's move to publicize what drugmakers charge it for vaccines showed that Western drugmakers often charged the agency double what companies in India and Indonesia do.

The aid group Doctors Without Borders criticized the vaccine body GAVI for spending hundreds of millions of dollars on anti-pneumonia vaccines from Western companies, saying it could put its buying power to even better use by fostering competition from emerging manufacturers like those in China.

GAVI's Schwalbe said the vaccine body has to buy what is available and negotiates hard for steep discounts. "We need to buy vaccines now to save children's lives now. We can't wait."



]]> 2011-12-02T03:29:10+00:00 http://www.therochesterdemocrat.com/index.php/weblog/obama_on_aids_we_can_beat_this_disease/ {summary} AIDS







WASHINGTON (AP) - President Barack Obama set an ambitious goal Thursday for significantly increasing access to life-saving AIDS drugs for people in the U.S. and around the world, as he announced a renewed American commitment to ending a pandemic that has killed 30 million people.

"We can beat this disease," Obama declared during a World AIDS Day event in Washington. Former Presidents George W. Bush and Bill Clinton also participated via satellite.

Obama pledged U.S. support to help 6 million people in countries hardest hit by the virus get access to antiretroviral drugs by the end of 2013, increasing the original U.S. goal by 2 million. And he announced plans to boost spending on HIV treatment in the U.S. by $50 million.

"The rate of new infections may be going down elsewhere, but it's not going down here in America," he said. "There are communities in this country being devastated still by this disease. When new infections among young, black, gay men increase by nearly 50 percent in three years, we need to do more to show them that their lives matter."

As part of Obama's new overseas initiatives, the U.S. will also aim to get antiretroviral drugs to 1.5 million HIV-positive pregnant women to prevent them from passing the virus to their children; distribute more than 1 billion condoms in the developing world in the next two years; and fund 4.7 million voluntary medical male circumcisions in eastern and southern Africa over the next two years. Research shows circumcisions reduce the risk of female-to-male HIV transmission by more than 60 percent.

The new global goals build on the work of the President's Emergency Plan for AIDS Relief, which focuses on prevention, treatment and support programs in 15 countries hit hardest by the AIDS pandemic, 12 of them in Africa. Bush launched the $15 billion plan in 2003, and in 2008, Congress tripled the budget to $48 billion over five years.

Obama praised Bush for his leadership on AIDS relief, saying the program will be one of the former president's greatest legacies.

"That program - more ambitious than even leading advocates thought was possible at the time - has saved thousands and thousands and thousands of lives, spurred international action, and laid the foundation for a comprehensive global plan that will impact the lives of millions," Obama said. "And we are proud that we have the opportunity to carry that work forward."

Despite Obama's more ambitious goals, the relief program's budget is not expected to increase. Instead officials said the expanded targets would be funded through savings achieved by making the program more efficient and cutting the costs of treatment.

The president urged other wealthy nations to fulfill their financial pledges to a global fund to fight HIV and AIDS, and jabbed those who have not contributed money.

"Countries that haven't made a pledge need to do so," he said. "That includes China and other major economies that are now able to step up as major donors."

Obama also announced new initiatives to combat HIV, the virus that causes AIDS, in the U.S. The White House said there are 1.2 million Americans living with HIV, and 50,000 new infections each year. Officials said he would direct the Department of Health and Human Services to increase funding for domestic treatment by $50 million

The bulk of the new funding - $35 million - will go to state programs that help people living with HIV and AIDS get access to medicine. There are currently more than 6,500 Americans living with the virus on waiting lists for medication, according to the White House.

The rest of the domestic funds will go to HIV medical clinics across the country, with an emphasis on areas where infections have increased and care and treatment are not readily available. Officials said the additional clinic funding would give 7,500 more patients access to treatment.

The $50 million is already part of the HHS budget, and officials said Obama does not need congressional approval to reallocate the funds.

The HIV virus has infected an estimated 60 million people worldwide since the deadly pandemic began 30 years ago. More than 33 million people are currently living with the virus.

While the failure to find an effective HIV vaccine continues to frustrate the medical community, experts say scientific research in recent years has led to substantial progress in preventing and treating the virus.

Obama ordered his staff to reevaluate both their international and domestic approaches to HIV and AIDS this summer after being briefed on the scientific advancements.

Members of both parties praised the new initiatives and commended Democratic and Republican leaders for coming together.

"Here's what we can do when we work together. We've got leaders of both political parties standing behind something that works," said Gayle Smith, Obama's senior director for development and democracy at the National Security Council.

Tony Fratto, a former Bush spokesman, urged both parties to avoid making the fight against AIDS a political issue.

"The only way to undermine this historic undertaking is if it becomes a partisan issue," he said. "The reasons a Barack Obama and a George W. Bush can support America's leading role in addressing this disease may be very different, but what's important is they've sought the same goal."



]]> 2011-12-02T02:48:45+00:00 http://www.therochesterdemocrat.com/index.php/weblog/apple_juice_can_pose_a_health_risk_--_from_calories/ {summary} Child Health






It's true - apple juice can pose a risk to your health. But not necessarily from the trace amounts of arsenic that people are arguing about.

Despite the government's consideration of new limits on arsenic, nutrition experts say apple juice's real danger is to waistlines and children's teeth. Apple juice has few natural nutrients, lots of calories and, in some cases, more sugar than soda has. It trains a child to like very sweet things, displaces better beverages and foods, and adds to the obesity problem, its critics say.

"It's like sugar water," said Judith Stern, a nutrition professor at the University of California, Davis, who has consulted for candy makers as well as for Weight Watchers. "I won't let my 3-year-old grandson drink apple juice."

Many juices are fortified with vitamins, so they're not just empty calories. But that doesn't appease some nutritionists.

"If it wasn't healthy in the first place, adding vitamins doesn't make it into a health food," and if it causes weight gain, it's not a healthy choice, said Karen Ansel, a registered dietitian in New York and spokeswoman for the American Dietetic Association.

The American Academy of Pediatrics says juice can be part of a healthy diet, but its policy is blunt: "Fruit juice offers no nutritional benefit for infants younger than 6 months" and no benefits over whole fruit for older kids.

Kids under 12 consume 28 percent of all juice and juice drinks, according to the academy. Nationwide, apple juice is second only to orange juice in popularity. Americans slurp 267 ounces of apple juice on average each year, according to the Food Institute's Almanac of Juice Products and the Juice Products Association, a trade group. Lots more is consumed as an ingredient in juice drinks and various foods.

Only 17 percent of the apple juice sold in the U.S. is produced here. The rest comes from other countries, mostly China, Argentina, Chile and Brazil, the association says.

Television's Dr. Mehmet Oz made that a key point a few months ago when he raised an alarm - some say a false alarm - over arsenic in apple juice, based on tests his show commissioned by a private lab. The Food and Drug Administration said that its own tests disagreed and that apple juice is safe.

However, on Wednesday, after Consumer Reports did its own tests on several juice brands and called along with other consumer groups for stricter standards, the FDA said it will examine whether its restrictions on the amount of arsenic allowed in apple juice are stringent enough.

Some forms of arsenic, such as the type found in pesticides, can be toxic and may pose a cancer risk if consumed at high levels or over a long period.

All juice sold in the United States must be safe and meet U.S. standards, said Pat Faison, technical director for the juice association. As for making good nutrition choices, "a lot of the information that people need about fruit juices is on the label," she said.

So what's on those labels?

Carbohydrates, mostly sugars, in a much higher concentration than in milk. Juice has a small amount of protein and minerals and lacks the fiber in whole fruit, the pediatrics academy notes.

Drinking juice delivers a lot of calories quickly so you don't realize how much you've consumed, whereas you would have to eat a lot of apples to get the same amount, and "you would feel much, much more full from the apples," Ansel said.

"Whole fruits are much better for you," said Dr. Frank Greer, a University of Wisconsin, Madison, professor and former head of the pediatrics academy's nutrition committee.

He noted that the WIC program - the U.S. Department of Agriculture's nutrition program for Women, Infants and Children - revised its rules in 2005 to replace juice with baby food fruits and vegetables for children over 6 months. More than half of all infants born in the U.S. are eligible for WIC, and the government "really cut back severely on the ability of mothers to get fruit juices" through the program, Greer said.

If you or your family drinks juice, here is some advice from nutrition experts:

-Choose a juice fortified with calcium and vitamin D-3.

-Give children only pasteurized juice - that's the only type safe from germs that can cause serious disease.

-Don't give juice before 6 months of age, and never put it in bottles or covered cups that allow babies and children to consume it throughout the day, which can cause tooth decay. For the same reason, don't give infants juice at bedtime.

-Limit juice to 4 to 6 ounces per day for children ages 1 to 6, and 8 to 12 ounces for those ages 7 to 18.

-Encourage kids to eat fruit.

-Don't be swayed by healthy-sounding label claims. "No sugar added" doesn't mean it isn't full of naturally occurring sugar. And "cholesterol-free" is silly - only animal products contain cholesterol.


Online:

Academy of Pediatrics on juice: http://tinyurl.com/qtkls

FDA: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm271394.htm

WIC program advice: http://bit.ly/sYXqAi

Industry: http://www.fruitjuicefacts.org




]]> 2011-12-02T02:42:47+00:00 http://www.therochesterdemocrat.com/index.php/weblog/fda_revokes_approval_of_avastin_for_breast_cancer/ {summary} Cancer






WASHINGTON (AP) - The blockbuster drug Avastin should no longer be used in advanced breast cancer patients because there's no proof that it extends their lives or even provides enough temporary benefit to outweigh its dangerous side effects, the government declared Friday.

The ruling by the Food and Drug Administration was long expected, but it was certain to disappoint women who say they've run out of other options as their breast cancer spread through their bodies. Impassioned patients had lobbied furiously to preserve Avastin as a last shot.

But repeated studies found the drug had only a small effect on tumor growth. The research didn't show evidence that patients lived any longer or had a better quality of life than if they had taken standard chemotherapy. The FDA concluded that the drug presented an array of risks, including severe high blood pressure, massive bleeding, heart attack or heart failure, along with perforations in the stomach and intestines.

"I did not come to this decision lightly," said the FDA commissioner, Dr. Margaret Hamburg. But, she said, "Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing."

Avastin is the world's best-selling cancer drug, and also is used to treat certain forms of colon, lung, kidney and brain cancers. So even though FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it - but insurers may not pay for it. Including infusion fees, a year's treatment with Avastin can cost $100,000.

Some insurers already had quit covering the drug's use in breast cancer after FDA's advisers twice - once last year and once this summer - urged revoking the approval.

But Medicare said Friday that it will keep paying for now. In a statement, the agency said it "will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies."

Hamburg said any woman wishing to remain on Avastin should have an in-depth discussion with her doctor about the risks and what the research into the drug showed.

Avastin manufacturer Genentech, part of Swiss drugmaker Roche Group, had argued that the drug should remain available while it conducted more research to see if certain subsets of breast cancer patients might benefit, perhaps people whose tumors contain certain genetic characteristics. After all, some doctors had argued that they do see a few patients who seem to do better with Avastin than without it.

Hamburg said she considered that argument, but that scientifically there are no clues yet to identify such women. She urged Genentech to do that research, saying FDA "absolutely" would reconsider if the company could find the right evidence."

"We're eager to work with the company, and we hope that the science will advance and that we will be able to offer patients with metastatic breast cancer better, safer, more effective treatments for this devastating disease," Hamburg said.

Genentech pledged to begin such research.

"We are disappointed with the outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States," said company chief medical officer Dr. Hal Barron.

One patient advocacy group called the decision a mistake.

"Any one life is significant. In this case we're talking about several thousand lives a year," said Frank Burroughs of the Abigail Alliance, which advocates for access to experimental medicine.

In 2008, the FDA allowed Avastin to be marketed as a treatment for breast cancer that has spread, or metastasized, to other parts of the body and is generally considered incurable. The approval came under a special program that allows patients access to promising treatments while their makers finish the studies needed for final proof that they really work as promised. That approval is revoked if the research doesn't pan out, something that happens only very rarely.


]]> 2011-11-18T18:08:42+00:00 http://www.therochesterdemocrat.com/index.php/weblog/doctors_test_all_kids_for_cholesterol_by_age_11/ {summary} Child Health



LINDSEY TANNER and MARILYNN MARCHIONE
Associated Press
Published: Nov 11, 2011


CHICAGO (AP) - Every child should be tested for high cholesterol as early as age 9 - surprising new advice from a government panel that suggests screening kids in grade school for a problem more common in middle age.

The idea will come as a shock to most parents. And it's certain to stir debate.

The doctors on the expert panel that announced the new guidelines Friday concede there is little proof that testing now will prevent heart attacks decades later. But many doctors say waiting might be too late for children who have hidden risks.

Fat deposits form in the heart arteries in childhood but don't usually harden them and cause symptoms until later in life. The panel urges cholesterol screening between ages 9 and 11 - before puberty, when cholesterol temporarily dips - and again between ages 17 and 21.

The panel also suggests diabetes screening every two years starting as early as 9 for children who are overweight and have other risks for Type 2 diabetes, including family history.

The new guidelines are from an expert panel appointed by the National Heart, Lung and Blood Institute and endorsed by the American Academy of Pediatrics.

Some facts everyone agrees on:

- By the fourth grade, 10 to 13 percent of U.S. children have high cholesterol, defined as a score of 200 or more.

- Half of children with high cholesterol will also have it as adults, raising their risk of heart disease.

- One third of U.S. children and teens are obese or overweight, which makes high cholesterol and diabetes more likely.

Until now, cholesterol testing has only been done for kids with a known family history of early heart disease or inherited high cholesterol, or with risk factors such as obesity, diabetes or high blood pressure. That approach misses about 30 percent of kids with high cholesterol.

"If we screen at age 20, it may be already too late," said one of the guideline panel members, Dr. Elaine Urbina, director of preventive cardiology at Cincinnati Children's Hospital Medical Center. "To me, it's not controversial at all. We should have been doing this for years."

Elizabeth Duruz didn't want to take that chance. Her 10-year-old daughter, Joscelyn Benninghoff, has been on cholesterol-lowering medicines since she was 5 because high cholesterol runs in her family. They live in Cincinnati.

"We decided when she was 5 that we would get her screened early on. She tested really high" despite being active and not overweight, Duruz said. "We're doing what we need to do for her now, and that gives me hope that she'll be healthy."

Dr. Roger Blumenthal, who is preventive cardiology chief at Johns Hopkins Medical Center and had no role in the guidelines, said he thinks his 12-year-old son should be tested because he has a cousin with very high "bad" cholesterol who needed heart bypass surgery for clogged arteries in his 40s.

"I'm very supportive" of universal screening, he said. "The knowledge of their cholesterol numbers as well as their blood sugar levels can be very helpful for the physicians and their families about which patients are headed toward diabetes."

Dr. William Cooper, a pediatrics and preventive medicine professor at Vanderbilt University, said expanding the testing guidelines "would seem to me to make sense."

But he added: "One of the risks would be that we would be treating more kids, potentially, and we don't know yet the implications of what we're treating. Are we treating a number or are we treating a risk factor?"

That's the reason a different group of government advisers, the U.S. Preventive Services Task Force, concluded in 2007 that not enough is known about the possible benefits and risks to recommend for or against cholesterol screening for children and teens.

One of its leaders, Dr. Michael LeFevre, a family medicine specialist at the University of Missouri, said that for the task force to declare screening beneficial there must be evidence that treatment improves health, such as preventing heart attacks, rather than just nudging down a number - the cholesterol score.

"Some of the argument is that we need to treat children when they're 14 or 15 to keep them from having a heart attack when they're 50, and that's a pretty long lag time," he said.

The guidelines say that cholesterol drugs likely would be recommended for less than 1 percent of kids tested, and they shouldn't be used in children younger than 10 unless they have severe problems.

"We'll also continue to encourage parents and children to make positive lifestyle choices to prevent risk factors from occurring," steps such as diet and exercise, said Dr. Gordan Tomaselli, president of the American Heart Association. The group praised the guidelines and will host a presentation on them Sunday at its annual conference in Florida.

Cholesterol tests cost around $80 and usually are covered by health insurance. Several of the 14 doctors on the guidelines panel have received consulting fees or have had other financial ties to makers of cholesterol medicines.

Typically, cholesterol drugs are used indefinitely but they are generally safe, said Dr. Sarah Blumenschein, director of preventive cardiology at Children's Medical Center in Dallas, who had no role in the guidelines but supports them.

"You have to start early. It's much easier to change children's behavior when they're 5 or 10 or 12" than when they're older, she said.

The guidelines also say doctors should:

- Take yearly blood pressure measurements for children starting at age 3.

- Start routine anti-smoking advice when kids are ages 5 to 9, and counsel parents of infants not to smoke in the home.

- Review infants' family history of obesity and start tracking body mass index, or BMI, a measure of obesity, at age 2.

The panel also suggests using more frank terms for kids who are overweight and obese than some government agencies have used in the past. Children whose BMI is in the 85th to 95th percentile should be called overweight, not "at risk for overweight," and kids whose BMI is in the 95th percentile or higher should be called obese, not "overweight - even kids as young as age 2, the panel said.

"Some might feel that 'obese' is an unacceptable term for children and parents," so doctors should "use descriptive terminology that is appropriate for each child and family," the guidelines recommend.

They were released online Friday by the journal Pediatrics.

Online:

Guidelines: http://tinyurl.com/7csojas

NHLBI panel: http://www.nhlbi.nih.gov/guidelines/cvd_ped/index.htm

Cholesterol info: http://tinyurl.com/23dtxvo

and http://www.nhlbi.nih.gov/health/public/heart/index.htm(hash)chol




]]> 2011-11-15T01:32:21+00:00 http://www.therochesterdemocrat.com/index.php/weblog/high-fiber_diet_may_help_thwart_colon_cancer/ {summary} Cancer


By HealthDay
November 11, 2011


Eating a high-fiber diet may reduce your risk of colorectal cancer, especially if the fiber is from cereal and whole grains, according to a new review.
Consuming 90 grams more a day of whole grains was associated with about a 20 percent lower risk.


Leslie Smith, USA TODAY



British and Dutch researchers analyzed 25 studies that included a total of nearly 2 million people. Compared with the lowest levels of fiber consumption, each 10 gram per day increase in intake of total dietary fiber and cereal fiber was associated with a 10 percent reduced risk of colorectal cancer.

Consuming 90 grams more a day (three servings, or three and one-quarter ounces) of whole grains was associated with about a 20 percent lower risk.

The review did not find significant evidence of a link between fruit or vegetable fiber and colorectal cancer risk.

A previous analysis did find that a high intake of fruit and vegetables was associated with a reduced risk of colorectal cancer, which suggests that components other than fiber in fruits and vegetables may play a role, the researchers said.

The study appears online Nov. 11 in BMJ.

"In summary, our meta-analysis suggests that a high intake of dietary fiber, particularly from cereal and whole grains, is associated with a reduced risk of colorectal cancer," the researchers wrote in a journal news release.

They also noted that a high-fiber diet may reduce the risk of cardiovascular disease, type 2 diabetes, overweight, obesity and possibly overall risk of death.

One expert said there may be a physiological basis for the anti-cancer benefit of a high-fiber diet.

"This study highlights the importance of a diet rich in fiber," said Dr. Anthony Starpoli, a gastroenterologist at Lenox Hill Hospital in New York City. "We know that soluble is most helpful in improving colon transit times. As the contents of the colon move at a better rate, there is thought to be less toxic exposure to the interior of the colon thereby reducing risk of developing colon cancer," he explained.

Colorectal cancer is the third most common cancer worldwide, with 1.2 million new cases diagnosed each year, the news release noted.

The findings provide more evidence of the many health benefits of whole grains, but further research is needed to learn how this occurs, Anne Tjonneland, from the Danish Cancer Society, added in an accompanying editorial.


]]> 2011-11-15T01:20:00+00:00 http://www.therochesterdemocrat.com/index.php/weblog/1_in_10_adults_could_have_diabetes_by_2030/ {summary} Diabetes



GENEVA (AP) - The International Diabetes Federation predicts that at least one in 10 adults could have diabetes by 2030, according to its latest statistics.

In a report issued on Monday, the advocacy group estimated that 552 million people could have diabetes in two decades' time based on factors like aging and demographic changes. Currently, the group says that about one adult in 13 has diabetes.

The figure includes both types of diabetes as well as cases that are undiagnosed. The group expects the number of cases to jump by 90 percent even in Africa, where infectious diseases have previously been the top killer. Without including the impact of increasing obesity, the International Diabetes Federation said its figures were conservative.

According to the World Health Organization, there are about 346 million people worldwide with diabetes, with more than 80 percent of deaths occurring in developing countries. The agency projects diabetes deaths will double by 2030 and said the International Diabetes Federation's prediction was possible.

"It's a credible figure," said Gojka Roglic, head of WHO's diabetes unit. "But whether or not it's correct, we can't say."

Roglic said the projected future rise in diabetes cases was because of aging rather than the obesity epidemic. Most cases of diabetes are Type 2, the kind that mainly hits people in middle age, and is linked to weight gain and a sedentary lifestyle.

Roglic said a substantial number of future diabetes cases were preventable. "It's worrying because these people will have an illness which is serious, debilitating, and shortens their lives," she said. "But it doesn't have to happen if we take the right interventions."


Online:

http://www.idf.org

http://www.who.int



]]> 2011-11-14T15:05:32+00:00