Novel vaccine fights Type 1 diabetes by stopping immune attack

Novel vaccine fights Type 1 diabetes by stopping immune attack

NEW YORK â€" An experimental vaccine designed to tamp down the abnormal immune response that causes Type 1 diabetes helped preserve patients' insulin-producing cells in a study that may change the way the disease is treated.

Researchers from Stanford University in California and Leiden University Medical Center in the Netherlands created a vaccine that selectively targets the destructive immune cells and stops their attack. The data, from the second of three stages of tests generally needed for regulatory approval, were published Wednesday in the journal Science Translational Medicine.

Type 1 diabetes is caused when the body's immune system destroys insulin-releasing cells in the pancreas, called beta cells, requiring patients to inject themselves with insulin replacement therapy. Scientists have long sought a treatment approach that targets the cause of the disease.

"Although insulin saves people's lives and was discovered 100 years ago, we need something better than that," Lawrence Steinman, a professor at Stanford School of Medicine near Palo Alto, Calif., and an author of the study, said in a telephone interview. "One of the long sought-after goals of immunological therapy is to do just this, antigen-specific modulation."

Type 1 diabetes, also called juvenile diabetes, affects as many as 3 million people in the U.S., according to JDRF, an organization that funds research for the disease. It's less common than Type 2 diabetes, which develops when the body becomes resistant to insulin or the pancreas stops producing enough insulin, and is linked to excess weight.

The compound, called TOL-3021, boosted the function of pancreatic beta cells and specifically reduced the killer immune cells implicit in Type 1 diabetes.

The trial was done in 80 patients ages 18 to 40 who had been diagnosed with Type 1 diabetes within 5 years. Patients were given an injection of the compound or placebo once a week for 12 weeks, and researchers looked at levels of C-peptide as a marker of the function of insulin-producing beta cells.

Patients taking a 1-milligram dose of TOL-3021 had their C- peptide levels rise 20 percent, compared with a decline of 8.8 percent for patients on placebo, the researchers reported. Immune cells known as T cells that directly targeted the pancreatic beta cells were shown to decline in patients taking the drug, while other T cells weren't affected. The study turned up no serious side effects.

Steinman said a next step is to conduct a longer trial with more patients to determine how the drug works over a period as long as a year, and to pursue treatment of patients at different stages of the disease.

"We do want to look at treatment of children, and the ultimate would be to see if we can treat those at risk before they get the disease and do this in a preventive way," Steinman said. On the other end of the spectrum, "it could provide benefit, as we've seen here, to people who were diagnosed a few years ago as long as they have some islet cells to preserve."

Steinman and colleagues formed a company around the technology in April, called Tolerion Inc. They are looking at partnerships with pharmaceutical companies "and other vehicles for moving ahead," he said. The company may be able to use the platform in other autoimmune diseases in which the target of the errant immune response is known, such as Grave's disease, he said.

"The wind at our back is the good data we've seen in this trial," Steinman said.

Pennsylvania girl got second lung transplant after first failed

Pennsylvania girl got second lung transplant after first failed

In a Facebook update, Sarah Murnaghan’s mother said her daughter’s condition “spiraled out of control” hours after the family announced on June 12 that the first surgery -- which was done after a federal judge intervened to allow Sarah to receive adult lungs -- had been a success. 

The complication, called primary graft failure, occurs in 10% to 25% of lung transplants, Janet Murnaghan said in the update.

After moving Sarah to an emergency bypass machine, doctors told the Murnaghan family it was unlikely the girl would survive more than a week.

In a news conference Friday afternoon in Philadelphia, Janet Murnaghan said the family was not prepared to disclose Sarah’s condition at that time, the Associated Press reported.

“We were told … that she was going to die,” Murnaghan said. “We weren’t prepared to live out her dying in public.”

The family reported publicly that Sarah was awake and responsive at the same time that doctors were trying to find a new set of lungs.  

In the Facebook posting, the family said they learned on June 15 that new lungs were available, but the surgery was risky because the lungs were infected with pneumonia. They took the chance.  

Ever since, Janet Murnaghan wrote, her daughter’s condition has steadily improved. The girl is now doing well, and this week took her first breaths on her own without the help of a ventilator, she said.

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devin.kelly@latimes.com

Twitter: @devkelly17

 

New Type 1 diabetes vaccine shows promising results

New Type 1 diabetes vaccine shows promising results

A clinical trial for a Type 1 diabetes vaccine has resulted in promising findings, suggesting there may be a future where we can prevent people from getting the disease.

Researchers completed a 12-week trial on a DNA-based vaccine on 80 subjects with Type 1 diabetes. The patients were able to maintain levels of a blood-borne intermediary that can stimulate insulin production, and some subjects were able to increase levels. That suggests the cellular changes that occur in patients with Type 1 diabetes may be shut down. 

"We're very excited by these results, which suggest that the immunologist's dream of shutting down just a single subset of dysfunctional immune cells without wrecking the whole immune system may be attainable," study author Dr. Lawrence Steinman, professor of pediatrics and neurological sciences at Stanford University in Calif., said in a press release. "This vaccine is a new concept. It's shutting off a specific immune response, rather than turning on specific immune responses as conventional vaccines for, say, influenza or polio aim to do."

Type 1 diabetes affects up to 3 million Americans, the study authors noted. While it isn't as common as Type 2 diabetes, it typically manifests at an earlier age and requires multiple daily injections of insulin throughout life.

In Type 1 diabetes, the immune system attacks its own beta cells, a cell found in the pancreas. Beta cells store and release insulin, which is a hormone necessary to turn sugar -- or glucose -- into energy for the body's use. It is unknown what causes Type 1 diabetes.

• Artificial pancreas effective in study, could one day help diabetics

The experimental vaccine works by targeting and suppressing a set of immune cells called CD8, which are thought to attack insulin-producing beta cells. When different cells make proteins, they put small segments of the protein called peptides on their surfaces so "patrolling" CD8 cells can inspect them. CD8 ignores most peptides on healthy cells, but when a peptide looks out of the ordinary, it attacks the cell.

One hypothesis about Type 1 diabetes is that a patient has confused CD8 cells that incorrectly read a protein called proinsulin -- which the body uses to make insulin out of -- as foreign. The proinsulin-targeting CD8 cells then attack the beta cells that the proinsulin is resting on.

The vaccine that is being tested, called TOL-302, contains DNA that codes for proinsulin. When the body processes the vaccine, it sends an anti-inflammatory signal to only the CD8 cells. This then tells the proinsulin-targeting CD8 to leave the beta cells alone.

The researchers tested the vaccine through weekly  shots in Type 1 diabetic patients. They were randomized to receive four different doses and a placebo shot. Researchers measured the levels of C-peptide, a portion of proinsulin that gets removed when insulin is made, in the patients' blood stream. Levels were measured during the fifth and 15th weeks and then six, nine, 12, 18 and 24 months after starting on the vaccination regimen. Each time, researchers took blood samples 30, 60, 90 and 120 minutes after patients drank a modified milkshake.

Since C-peptide remains in the body longer than insulin, it can serve as a good intermediary between beta cells and further insulin production. C-peptide has also been shown to stop or reduce some of the long-term effects of diabetes including eye, kidney and nerve damage.

This trial was initially done to find out about dosing and the safety of the vaccine. However, the results revealed more. Th e researchers found that amounts of proinsulin-targeting CD8 cells -- but not any other Types of immune cells -- were much lower in people who had received the vaccine, compared with those who got the placebo. However, C-peptide remained the same or even increased in some cases.

A DNA-based vaccine has never been approved by the Food and Drug Administration (FDA), and many more trials with more subjects need to occur, the researchers said. In addition, the vaccine's effectiveness dropped after the 12-week period, so the current formula may not offer long-term protection. Experts say a working vaccine is still years away, but this trial's results are promising and a good start.

"For the first time we have evidence that this particular type of vaccine has an effect in preserving insulin production in humans. This is a significant step forward on the journey towards a world without Type 1 diabetes," Karen Addington, the UK chief executive of the Type 1 diabetes c harity Juvenile Diabetes Research Foundation, said to the BBC. "We will build on this exciting DNA vaccine approach."

The study was published on June 26 in Science Translational Medicine.

ADA: Lifestyle Changes Don't Protect Diabetic Heart

ADA: Lifestyle Changes Don't Protect Diabetic Heart

halted in September for failing to show cardiovascular benefit, revealed no significant differences in a composite of cardiovascular endpoints between those who had the intervention and those who only received advice (1.83 events per 100 person-years versus 1.92, P=0.51), according to Rena Wing, PhD, of Brown University, and colleagues.

They reported their findings simultaneously online in the New England Journal of Medicine and at the American Diabetes Association meeting here.

Wing said during a press briefing that there are a host of explanations for the lack of benefit, among them the fact that participants in the control group were on more medications, particularly statins, which could have lowered their risk of cardiovascular disease, and they also received good education on their disease and on lifestyle.

Also, Wing and colleagues noted, the weight loss achieved by those in the intense group may not have been sufficient to reduce the risk of cardiovascular disease; or the education received in the control group could have lessened the difference between the two groups.

Regardless of the lack of overall cardiovascular benefit, Wing said, the trial was valuable in that it showed patients with diabetes "can lose weight and maintain that weight loss. This weight loss has many beneficial effects on glycemic control and cardiovascular risk factors."

"It just doesn't affect the risk of cardiovascular disease," she said during a press briefing.

Smaller and shorter-term studies have shown that weight loss can improve cardiovascular disease risk factors for obese and overweight patients who have type 2 diab etes, but the long-term effects on hard cardiovascular endpoints such as MI and death have not been well studied.

Close-up Look at the Trial

Wing and her colleagues initiated the Look AHEAD (Action for Health in Diabetes) trial to assess those endpoints, enrolling 5,145 overweight or obese patients with type 2 diabetes at 16 centers in the U.S.

The patients were randomized to either an intensive lifestyle intervention that focused on weight loss through decreased caloric intake and increased physical activity, or to a control group that received only education about their disease.

Mean age of participants was 58.7, mean body mass index (BMI) was 36, the median duration of diabetes was 5 years, and 14% had a history of cardiovascular disease.

The primary outcome was a composite of death from cardiovascular causes, nonfatal MI, nonfatal stroke, and hospitalization for angina.

When the trial was stopped in September 2012, the median follow-up time was 9.6 years.

Wing and colleagues saw greater weight loss in the intervention group than among controls at one year (8.6% versus 0.7%) but that gap started to close toward the end of the study given that initial weight loss was followed by weight regain through year five and, thereafter, a subsequent gradual drop in weight (6% versus 3.5%).

Control patients had gradual but consistent weight loss throughout the study.

The intense lifestyle change also led to greater reductions in glycated hemoglobin (HbA1c) at one year, as well as greater initial improvements in fitness and all cardiovascular risk factors, except for LDL cholesterol at that time.

These between-group differences diminished over time, however, although HbA1c and systolic blood pressure showed the most sustained differences.

The use of antihypertensives, statins, and insulin was also lower in the intervention group than in the control group.

The primary composite outcome occurred in 403 patients in the intervention group and 418 in the control group, which did not translate to a significant difference (1.83 versus 1.92 events per 100 person-years, P=0.51).

Nor were there any significant differences between groups in terms of secondary composite outcomes or any of the individual cardiovascular events making up those outcomes.

With regard to adverse events, the rate of self-reported fractures was significantly higher in the intervention group (2.51 versus 2.16 per 100 person-years, P=0.01), but there were no significant differences in the rate of adjudicated fractures, they reported (1.66 and 1.64 per 100 person-years, respectively).

Wing noted that subgroup analyses looking at outcomes by history of cardiovascular disease didn't turn up any significant findings, but they did show "some suggestion" that the intervention was effective at reducing the risk of cardiovascular disease in patien ts without a history of heart problems.

"We are interested in following Look AHEAD participants over time to see if this nonsignificant effect increases or decreases over time," Wing said during the briefing. "I think that will be one of the important things to follow over time."

The study was limited because patients self-selected to enter the trial, so the findings may not generalize to all patients, particularly those who are less motivated. Also, it's unclear if other intense interventions, such as one that focused on dietary composition, may lead to different outcomes.

Still, the researchers concluded, the findings "must be considered in the context of other positive effects observed with this intervention," particularly the changes in HbA1c.

Study Did Show Other Benefits

During the meeting, other investigators in the Look AHEAD trial reported data from other analyses.

William Knowler, MD, PhD, MPH, of the National In stitute for Diabetes and Digestive and Kidney Diseases (NIDDK), said the intervention was associated with less kidney disease over 10 years, with a 31% lower annual rate of development for those in the intensive lifestyle management group.

He and his colleagues also found a 14% lower risk of retinopathy with the intervention, but there was no significant difference between groups in terms of neuropathy.

Lucy Faulconbridge, PhD, of the University of Pennsylvania, reported a 20% lower risk of depression over the trial period for participants in the lifestyle group. Rates of incident diabetes were 17.5% for those in the intervention group compared with 21% for those in the control group.

Remission rates were the same over the course of the trial, however, and there were no differences between groups in the incidence of use of antidepressants, she said.

There was a 3.1% difference between overall health-related quality of life between groups over the cour se of the study, but mental health-related quality of life was not different between the two.

Finally, Henry Glick, PhD, also of the University of Pennsylvania, presented data on cost-efficacy, noting that an 11.9% reduction in hospitalizations for the intensive lifestyle management group translated to an average savings of $294 per year and a $2,610 savings in discounted dollars over 10 years.

Also, a 6.3% reduction in medications translated to an annual savings of $278 per year and a $2,487 savings in discounted dollars over 10 years.

In an accompanying editorial, Hertzel Gerstein, MD, of the University of Hamilton in Ontario in Canada, wrote that the findings "may mean that lifestyle interventions do not effectively reduce the rate of cardiovascular events in patients with type 2 diabetes."

But Gerstein also noted that any differences could have been diminished by reduced use of cardioprotective drugs in the intervention group, and by the fact that the effects of the intervention on weight loss and other risk factors waned after the first few years.

And using hospitalization for angina as part of the composite endpoint "may have added noise and further obscured any emerging signal," given that the incidence of angina was nearly identical in the two groups, while all other endpoints numerically favored the intervention group.

Gerstein concluded that from the results of Look AHEAD, clinicians can "clearly assert that changes in activity and diet safely reduce weight and reduce the need for and cost of medications."

The study was supported by the NIH. Additional support was provided by several universities and by FedEx, Health Management Resources, Johnson Johnson, Nestle HealthCare Nutrition, Hoffman-La Roche, Abbott Nutrition, and Unilever North America.

The researchers reported relationships with Vivus, Eisai, Arena, Orexigen, Takeda, Novo Nordisk, Amylin/Lilly, BD, Abbott Diabetes Care, Janss en, Medtronic, Roche, Sanofi, Dainippon, Perrigo, Boehringer Ingelheim, Kowa, Medifast, Global Direction in Medicine, Herbalife, Allere Wellbeing, BodyMedia, JennyCraig, Nestle Nutrition Institute, JDRF, diaDexus, Amgen, Weight Watchers, and Nutrisystem.

The editorialist reported relationships with Sanofi, Lilly, Roche, Novartis, AstraZeneca, Bristol-Myers Squibb, Bayer, Novo Nordisk, Boehringer Ingelheim, and Merck.

Primary source: New England Journal of Medicine
Source reference:
Wing R, et al "Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes" N Engl J Med 2013; DOI: 10.1056/NEJMoa1212914.

Additional source: New England Journal of Medicine
Source reference:
Gerstein HC, et al "Do lifestyle changes redu ce serious outcomes in diabetes?" N Engl J Med 2013; DOI: 10.1056/NEJMe1306987.

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Kristina Fiore joined MedPage Today after earning a degree in science, health, and environmental reporting from NYU. She's had bylines in newspapers and trade and consumer magazines including Newsday, ABC News, New Jersey Monthly, and Earth Magazine. At MedPage Today, she reports with a focus on diabetes, nutrition, and addiction medici ne.

Unattractive Workers More Likely To Be Bullied

Unattractive Workers More Likely To Be Bullied

Editor's Choice
Academic Journal
Main Category: Psychology / Psychiatry
Also Included In: Anxiety / Stress
Article Date: 23 Jun 2013 - 0:00 PDT

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A new study conducted at Michigan State University found that "unattractive" and/or disagreeable people are at a higher risk of being bullied by their co-workers.


Brent Scott, the lead investigator of the study, said that the finding is rather "ugly" itself.

He added that even though many professionals like to believe they act mature at work, it can end up being "just like high school in many ways."

It's already established that attractive high school students are generally more popular and less likely to be bullied, however, this study is the first of its kind to identify a link between attractiveness and bullying in the workplace.

A total of 114 people who worked at a health care facility in the southeastern U.S. were surveyed.

They were asked questions about whether they were ever bullied or made fun of during work.

Some examples of workplace bullying among employees include:

• Shouting or swearing
• spreading false rumors
• pushing or other forms of physical abuse
• intimidating the employee
• tampering with their belongings

The attractiveness of the workers were judged by people who didn't know them.

Compared to the attractive employees those who were considered to be unattractive were much more harshly treated, even when factors such as age, gender, and how long they had worked there were taken into account.

In addition, questionnaires were given to the worker's family and friends to find out how agreeable and friendly they were.

Based on the results, the researchers found that disagreeable workers and unattractive employees were treated more harshly than their co-workers.

Scott concluded:

"Our findings revealed that both personality and appearance matter. Knowing the potential targets of hurtful behavior could help managers monitor susceptible employees to prevent them from becoming victims or to provide counseling and social support if prevention attempts fail."

The findings were published in the journal Human Performance.

The effects of workplace bullying

Workplace bullying inflicts more harm on employees than sexual harassment. A team at the University of Manitoba found that workers who experience bullying are more likely to quit their job or have worse relations with their bosses.

However, it's not only those who are the victims of bullying that are affected. A group of Canadian researchers found that working in a place where bullying is witnessed is more likely to make people want to leave their jobs than being the victim of bullying.


 In addition, a report published in BMJ Open revealed that people who witness bullying in the workplace, or are victims of bullying are more likely to be prescribed psychotropic medications, such as tranquilizers, sleeping pills or antidepressants.

Written by Joseph Nordqvist
Copyright: Medical News Today
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With FDA approval, fight ends over morning-after pill

With FDA approval, fight ends over morning-after pill

In a statement, the FDA said its action complied with an order by U.S. District Judge Edward Korman of New York, who had openly criticized the George W. Bush and Obama administrations for imposing restrictions on the sale of the pill for political reasons.

Last week, Korman gave grudging approval to a proposal from the FDA and the Department of Health and Human Services to approve Plan B One-Step for over-the-counter sales, but not other versions of the drug.

"Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," read Thursday's statement from Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Plan B One-Step, which is manufactured by the Israel-based pharmaceutical firm Teva, retails for about $60 a dose. It contains the synthetic hormone levonorgestrel, which blocks ovulation and impedes the mobility of sperm. It will not work if a woman is already pregnant, nor will it harm a developing fetus.

A two-pill version of the drug, also manufactured by Teva and called simply Plan B, was not included in the FDA's approval.

On Thursday, reproductive rights groups welcomed news of the action.

"It's about time," said Chris Iseli, a spokesman for the Center for Reproductive Rights. "It's taken too long to bring emergency contraception out from behind the pharmacy counter."

The center represented plaintiffs in a suit against the government charging that age requirements and point of sale restrictions were unfairly blocking access to a drug that was as safe as aspirin and should be available to women of all ages.

Iseli acknowledged that plaintiffs had hoped to win access to all versions of the drug, particularly cheaper generic varieties, but said Thursday's approval was a significant victory.

Although the FDA has officially removed restrictions on the drug's sale, the change does not take effect immediately. Packaging on the product must be changed to reflect the new rules, and old stock now in pharmacies must be sold according to the old rules. It could take weeks to months before the newly packaged drugs are available, and there is likely to be confusion among consumers and sales clerks.

In 2011, the FDA was poised to approve the drug's sale without a prescription, but that decision was overruled by Heath and Human Services Secretary Kathleen Sebelius, who, along with President Obama, voiced worries that open access would allow girls as young as 10 or 11 to buy the drug as easily as "bubble gum or batteries."

On April 5, Korman ordered that all levonorgestrel-based emergency contraceptives be available over the counter without a prescription, and gave the government 30 days to comply.

Instead of removing all restrictions, however, the FDA responded with new guidelines lowering the minimum purchasing age from 17 to 15. It also required that purchasers show an ID. At the same time, the U.S. attorney's office, which represented the FDA and the Health and Human Services Department in court, filed an appeal of Korman's order.

Korman refused to alter his order, however, and the government responded by saying it would approve Plan B One-Step and drop its appeal.

In accepting that offer last week, Korman voiced concern that the FDA might grant "marketing exclusivity" to Teva, essentially giving the drug manufacturer a three-year monopoly on the sale of non-prescription emergency contraceptives. Federal law permits the FDA to grant such exclusive agreements to drug firms that fund and conduct clinical trials that are deemed essential to the drug's approval.

Korman wrote that such exclusivity would "only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women."

monte.morin@latimes.com

Boy, 3, Hears for the First Time

Boy, 3, Hears for the First Time

Boy, 3, Hears for the First Time

AMA declares obesity a disease

AMA declares obesity a disease

The nation's leading physicians organization took the vote after debating whether the action would do more to help affected patients get useful treatment or would further stigmatize a condition with many causes and few easy fixes.

In the end, members of the AMA's House of Delegates rejected cautionary advice from their own experts and extended the new status to a condition that affects more than one-third of adults and 17% of children in the United States.

"Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately 1 in 3 Americans," said Dr. Patrice Harris, an AMA board member.

Tuesday's vote is certain to step up pressure on health insurance companies to reimburse physicians for the time-consuming task of discussing obesity's health risks with patients whose body mass index exceeds 30. It should also encourage doctors to direct these patients to weight-loss programs and to monitor their often-fitful progress.

The federally funded Medicare program, which insures an estimated 13 million obese Americans who are over 65 or disabled, already covers the costs of "intensive behavioral therapy" for obese patients, as well as bariatric surgery for those with additional health conditions. But coverage for such obesity treatments has been uneven among private insurers.

Insurers who are members of the California Assn. of Health Plans cover many services to treat medical conditions associated with obesity, including bariatric surgery and diabetes, said President and Chief Executive Patrick Johnston.

The AMA's decision essentially makes diagnosis and treatment of obesity a physician's professional obligation. As such, it should encourage primary care physicians to get over their discomfort about raising weight concerns with obese patients. Studies have found that more than half of obese patients have never been told by a medical professional they need to lose weight â€" a result not only of some doctors' reluctance to offend but of their unwillingness to open a lengthy consultation for which they might not be reimbursed.

Past AMA documents have referred to obesity as an "urgent chronic condition," a "major health concern" and a "complex disorder." The vote now lifts obesity above the status of a health condition, disorder or marker for heightened risk of disease â€" as high cholesterol is for heart disease, for instance.

"As things stand now, primary care physicians tend to look at obesity as a behavior problem," said Dr. Rexford Ahima of University of Pennsylvania's Institute for Diabetes, Obesity and Metabolism. "This will force primary care physicians to address it, even if we don't have a cure for it."

The new designation follows a steep 30-year climb in Americans' weight â€" and growing public concern over the resulting tidal wave of expensive health problems. Treatment of such obesity-related illnesses as cardiovascular disease, Type 2 diabetes and certain cancers drives up the nation's medical bill by more than $150 billion a year, according to the Centers for Disease Control and Prevention.

Projected increases in the obesity rate could boost that figure by an additional $550 billion over the next 20 years, a recent Duke University study concluded.

In laying out the case for and against the redefinition of obesity, the AMA's Council on Science and Public Health argued that more widespread recognition of obesity as a disease "could result in greater investments by government and the private sector to develop and reimburse obesity treatments."

The Food and Drug Administration, which has approved just two new prescription weight-loss medications since 1999, would probably face increased pressure to approve new obesity drugs, spurring new drug development and more widespread prescribing by physicians, the council noted.

"The greater urgency a disease label confers" also might boost support for obesity-prevention programs such as physical education initiatives and reforms to school lunch, the council added. In addition, it speculated that "employers may be required to cover obesity treatments for their employees and may be less able to discriminate on the basis of body weight."

But the council also said that making obesity a disease could deepen the stigma attached to being overweight and doom some patients to endless nagging â€" even if they were otherwise healthy or had lost enough weight to improve their health.

It might also shift the nation's focus too much toward expensive drug and surgical treatments and away from measures to encourage healthy diets and regular exercise, the council wrote in a background memo for AMA members.

Dr. Daniel H. Bessesen, an endocrinologist and obesity expert at the University of Colorado Anschutz Medical Campus, called the AMA's shift "a double-edged sword." Though the semantic change may reflect "a growing awareness that obesity is not someone's fault," he worried that "the term disease is stigmatizing, and people who are obese don't need more stigmatizing."

melissa.healy@latimes.com

anna.gorman@latimes.com

Daily Pill Cuts HIV Risk in IV Drug Users

Daily Pill Cuts HIV Risk in IV Drug Users

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Michael Smith

North American Correspondent

North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers' Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Pres s International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.

Worried about type 2 diabetes? Walk after every meal

Worried about type 2 diabetes? Walk after every meal

A new study shows the benefits of walking for 15 minutes after every meal.

Walking after a meal may reduce the risk of type 2 diabetes, according to a new study.(Photo: Bob Riha Jr., USA TODAY)

If you're at risk for developing type 2 diabetes, then take a 15-minute walk after every meal.

A study, out today, shows that moderately-paced walks after meals work as well at regulating overall blood sugar in adults with pre-diabetes as a 45-minute walk once a day.

And there's an added benefit of walking after every meal, especially dinner: It helps lower post-meal blood sugar for three hours or more, the research found.

Walking after a meal "really blunts the rise in blood sugar," says the study's lead author Loretta DiPietro, professor and chair of the department of exercise science at the George Washington University School of Public Health and Health Services.

"You eat a meal. You wait a half-hour and then you go for a 15-minute walk, and it has proven effective in controlling blood sugar levels, but you have to do it every day after every meal. This amount of walking is not a prescription for weight loss or cardiovascular fitness â€" it's a prescription for controlling blood sugar," she says.

The Italians call the walk after dinner a passeggiata and know it aids in digestion, DiPietro says. "Now we know it also helps the clearance of blood sugar."

Currently, almost 26 million children and adults (8.3% of the population) in the USA have diabetes, and abou t 79 million Americans have pre-diabetes. In diabetes, the body does not make enough of the hormone insulin, or it doesn't use it properly. Insulin helps glucose (sugar) get into cells, where it is used for energy. If there's an insulin problem, sugar builds up in the blood, damaging nerves and blood vessels.

DiPietro and colleagues worked with 10 overweight, sedentary volunteers, who were an average age of 71. All had higher than normal blood sugar levels and were considered pre-diabetic, which means they were at risk for developing type 2 diabetes, the most common type.

Each participant stayed in a metabolic chamber, a special room that helps researchers track the calories burned by the volunteers, for two days on three separate occasions.The first day on each occasion was considered a control day, and participants did no physical activity.

On the second day, the participants did one of three things: They walked at an easy to moderate pace (about 3 mph) on a treadmill for 15 minutes â€" about a half hour after each meal.

On the other days the participants either walked for 45 minutes at 10:30 a.m. or they walked the same amount of time at 4:30 p.m. Their blood sugar levels were measured continuously throughout the two-day period.

The research, published in the June issue of Diabetes Care, shows that the timing of walks is important for providing health benefits, DiPietro says. Walking is beneficial because the muscle contractions "help to clear blood sugar," she says.

After dinner is a good time to get up and walk with your partner, a neighbor or your dog, she says. If you can't go outside, then march in place for 15 minutes, she says.

After lunch, many employees go and sit down for another four hours, but based on these findings, companies and businesses should make it easier for employees to go out and take a walk after lunch, says Tim Church, director of preventive medicine research at t he Pennington Biomedical Research Center in Baton Rouge.

John Anderson, president of medicine and science for the American Diabetes Association, says it makes sense that a short walk would lower post-meal blood sugar. "What we don't know is if it is going to make a big difference over time in people's progression from prediabetes to diabetes â€" any more than the standard exercise advice of walking 30 minutes a day five days a week."

Other research shows that amount of exercise and a weight loss of 5% to 7% helps reduce the risk of developing the disease, Anderson says.

DiPietro says the results of this study may also apply to pregnant women who are at risk for gestational diabetes, and the findings may also be helpful to people who aren't able to walk for 45 minutes at a time but are able to do 15 minutes.

The study was sponsored by the National Institute on Aging, part of the National Institutes of Health.

The government's exercise guidelin es recommend that:

• Adults get at least 2½ hours of moderate-intensity physical activity each week, such as brisk walking, or 1¼ hours of a vigorous-intensity activity, such as jogging or swimming laps, or a combination of the two types, to get the most health benefits from exercise. These aerobic activities should be done in at least 10-minute bouts.

• To get even more health benefits, people should do five hours of moderate-intensity physical activity each week or 2½ hours of vigorous activity.

• Adults should do muscle-strengthening (resistance) activities at a moderate- or high-intensity level for all major muscle groups two or more days a week. This should include exercises for the chest, back, shoulders, upper legs, hips, abdomen and lower legs. The exercises can be done with free weights or machines, resistance bands, calisthenics that use body weight for resistance (push-ups, pull-ups, sit-ups), or carrying heavy loads or doing heavy gard ening such as digging or hoeing.

Campaigners celebrate as Plan B morning-after pill made available to all

Campaigners celebrate as Plan B morning-after pill made available to all

Campaigners have welcomed as a "huge breakthrough" the Obama administration's decision to give up its fight to limit the sale of a morning-after pill.

Plan B will soon become available to women and girls of all ages without a prescription, following a decade-long battle which pitted successive White House administrations and the Food and Drug Administration against reproductive-rights campaigners, physicians and women's groups seeking to make emergency contraception universally available. Such groups have long argued that since morning-after pills such as Plan B One Step are very time sensitive and safe, they should be as available as over-the-counter pain relievers. Plan B and similar medicines which delay ovulation are most effective within 72 hours of unp rotected sex.

In a letter on Monday, the Justice Department said it planned to comply with a court's ruling to allow unrestricted sales of Plan B One Step and said it would withdraw its appeal against it. It said it would put into place Judge Edward Korman's order to have the FDA approve the pill for non-prescription use.

In 2009, the pill became available without prescription to women over the age of 17 who present proof of identification. In Plan B, the synthetic hormone levonorgestrel acts to postpone ovulation, preventing sperm from coming into contact with an egg. It does not cause an abortion or otherwise end a pregnancy and will not work if a woman is already pregnant.

Reproductive-rights campaigners, who first petitioned to have Plan B available over the counter and without a prescription in 2001, said the administration should also make other, cheaper versions of emergency contraception available. Other brands of emergency contraceptives will not be similarly available; nor will a two-pill version of Plan B, which is manufactured by an Israel-based pharmaceutical firm, Teva.

Nancy Northup, president and chief executive of the Center for Reproductive Rights, said she would continue to fight for fair treatment for "women who want and need more affordable options".

"Now that the appeals court has forced the federal government's hand," she said, "the FDA is finally taking a significant step forward by making Plan B One-Step available over the counter for women of all ages. But the Obama administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception."

Korman, who has been highly critical of the government's actions during the case, has written in court documents that the health and human services secretary, Kathleen Sebelius, acted in "bad faith" a nd was "politically motivated" when she overruled the FDA's 2011 effort to make the drugs available to all ages without a prescription. Barack Obama publicly supported Sebelius's decision and spoke of his two daughters, saying the thought of the drug being available without a prescription would make him uncomfortable.

On 5 April, Judge Korman issued an order that the drugs must be sold over the counter without age restrictions and within 30 days. Instead, the FDA lowered the minimum purchasing age from 17 to 15. Korman has also said that statistics show the FDA's recent decision places "a disproportionate burden" on African Americans and the less well off. This, he said, is in part because the FDA decision does not apply to generic drugs, which are typically le ss expensive.

In Monday's letter to Korman, Loretta Lynch, US attorney for the eastern district of New York, writes that other manufacturers could submit approval applications, but adds that the FDA might grant Teva "marketing exclusivity". Lynch states that the government and the FDA believe that only the one-step pill should be available over the counter, because of "significant differences" between Plan B One Step and the two-step product. There was, it said, fewer data on the use of the two-step product as a non-prescription drug by younger adolescents.

Dr Tracy Wilkinson, a paediatrician and member of Physicians for Reproductive Health, said the administration's original appeal had surprised the medical profession, because it had pledged not to put politics ahead of science. She said: "There have been mountains of evidence about the safety and efficacy of this medicine for women of all ages and so restricting it on the basis of anyone's age had no scientific basis."

Dr Wilkinson said that multiple studies had also shown that "women of all ages" can read a label and take medicine such as Plan B, which involves taking two tablets.

In a statement, Cecile Richards, the president of the Planned Parenthood Federation of America said: "This is a huge breakthrough for access to birth control and a historic moment for women's health and equity. The FDA's decision will make emergency contraception available on store shelves, just like condoms, and women of all ages will be able to get it quickly in order to prevent unintended pregnancy."

Unrestricted access to emergency contraception is supported by an array of medical groups, including the American Medical Association. Last year, the American Academy of Pediatrics said underage teens should be given emergency contraception before they start to have se x, in order to tackle teenage pregnancies.

In the US, teenage pregnancies have dropped over the last 20 years. But according to a study published last month by the Center for Disease Control and Prevention, the country still has one of the highest rates of such pregnancies in the developed world. There were 31.3 pregnancies per 1,000 teenagers in the US in 2011, compared to 25 per 1,000 in Britain in 2009 and 10.2 in France in 2008, according to UN figures.

Campaigners celebrate as Plan B morning-after pill made available to all

Campaigners celebrate as Plan B morning-after pill made available to all

Campaigners have welcomed as a "huge breakthrough" the Obama administration's decision to give up its fight to limit the sale of a morning-after pill.

Plan B will soon become available to women and girls of all ages without a prescription, following a decade-long battle which pitted successive White House administrations and the Food and Drug Administration against reproductive-rights campaigners, physicians and women's groups seeking to make emergency contraception universally available. Such groups have long argued that since morning-after pills such as Plan B One Step are very time sensitive and safe, they should be as available as over-the-counter pain relievers. Plan B and similar medicines which delay ovulation are most effective within 72 hours of unp rotected sex.

In a letter on Monday, the Justice Department said it planned to comply with a court's ruling to allow unrestricted sales of Plan B One Step and said it would withdraw its appeal against it. It said it would put into place Judge Edward Korman's order to have the FDA approve the pill for non-prescription use.

In 2009, the pill became available without prescription to women over the age of 17 who present proof of identification. In Plan B, the synthetic hormone levonorgestrel acts to postpone ovulation, preventing sperm from coming into contact with an egg. It does not cause an abortion or otherwise end a pregnancy and will not work if a woman is already pregnant.

Reproductive-rights campaigners, who first petitioned to have Plan B available over the counter and without a prescription in 2001, said the administration should also make other, cheaper versions of emergency contraception available. Other brands of emergency contraceptives will not be similarly available; nor will a two-pill version of Plan B, which is manufactured by an Israel-based pharmaceutical firm, Teva.

Nancy Northup, president and chief executive of the Center for Reproductive Rights, said she would continue to fight for fair treatment for "women who want and need more affordable options".

"Now that the appeals court has forced the federal government's hand," she said, "the FDA is finally taking a significant step forward by making Plan B One-Step available over the counter for women of all ages. But the Obama administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception."

Korman, who has been highly critical of the government's actions during the case, has written in court documents that the health and human services secretary, Kathleen Sebelius, acted in "bad faith" a nd was "politically motivated" when she overruled the FDA's 2011 effort to make the drugs available to all ages without a prescription. Barack Obama publicly supported Sebelius's decision and spoke of his two daughters, saying the thought of the drug being available without a prescription would make him uncomfortable.

On 5 April, Judge Korman issued an order that the drugs must be sold over the counter without age restrictions and within 30 days. Instead, the FDA lowered the minimum purchasing age from 17 to 15. Korman has also said that statistics show the FDA's recent decision places "a disproportionate burden" on African Americans and the less well off. This, he said, is in part because the FDA decision does not apply to generic drugs, which are typically le ss expensive.

In Monday's letter to Korman, Loretta Lynch, US attorney for the eastern district of New York, writes that other manufacturers could submit approval applications, but adds that the FDA might grant Teva "marketing exclusivity". Lynch states that the government and the FDA believe that only the one-step pill should be available over the counter, because of "significant differences" between Plan B One Step and the two-step product. There was, it said, fewer data on the use of the two-step product as a non-prescription drug by younger adolescents.

Dr Tracy Wilkinson, a paediatrician and member of Physicians for Reproductive Health, said the administration's original appeal had surprised the medical profession, because it had pledged not to put politics ahead of science. She said: "There have been mountains of evidence about the safety and efficacy of this medicine for women of all ages and so restricting it on the basis of anyone's age had no scientific basis."

Dr Wilkinson said that multiple studies had also shown that "women of all ages" can read a label and take medicine such as Plan B, which involves taking two tablets.

In a statement, Cecile Richards, the president of the Planned Parenthood Federation of America said: "This is a huge breakthrough for access to birth control and a historic moment for women's health and equity. The FDA's decision will make emergency contraception available on store shelves, just like condoms, and women of all ages will be able to get it quickly in order to prevent unintended pregnancy."

Unrestricted access to emergency contraception is supported by an array of medical groups, including the American Medical Association. Last year, the American Academy of Pediatrics said underage teens should be given emergency contraception before they start to have se x, in order to tackle teenage pregnancies.

In the US, teenage pregnancies have dropped over the last 20 years. But according to a study published last month by the Center for Disease Control and Prevention, the country still has one of the highest rates of such pregnancies in the developed world. There were 31.3 pregnancies per 1,000 teenagers in the US in 2011, compared to 25 per 1,000 in Britain in 2009 and 10.2 in France in 2008, according to UN figures.

Second US family urges change to children's organ transplant policy

Second US family urges change to children's organ transplant policy

By Dan Kelley

PHILADELPHIA | Sat Jun 8, 2013 10:24pm EDT

PHILADELPHIA (Reuters) - A second family has stepped forward in the public fight to change a donor-organ policy that places sick children younger than 12 years of age at the bottom of the adult transplant list, regardless of the severity of their illness.

The mother of Javier Acosta, 11, who suffers from cystic fibrosis and needs a lung transplant, urged policymakers on Saturday to adopt new rules to make a life-saving adult lung more readily available to her gravely ill son.

"If Javier does not receive a transplant, he will die," Milagros Martinez said during a news conference in Philadelphia. "I say that's unfair because of a policy. It shouldn't be that way."

The family of Sarah Murnaghan, 10, who like Javier is suffering from cystic fibrosis, is also publicly calling for a change in transplant list policies administered by the Organ Transplant and Procurement Network.

The Murnaghan family efforts have garnered national media attention and scrutiny of lawmakers on Capitol Hill, some of whom have called on U.S. Health and Human Services Secretary Kathleen Sebelius to intervene.

Last week, U.S. District Judge Michael Baylson gra nted the two families a temporary court order barring enforcement of a policy that places children under age 12 at the bottom of the adult lung transplant list, regardless of their illness.

The Murnaghan and Acosta children are both awaiting lung transplants at the Children's Hospital of Philadelphia. While each is eligible for donor lungs from children, those are rare.

The lawsuits have led some to voice concerns that adding children to adult transplant rosters could end up pushing deserving older patients farther down the list.

But Stephen Harvey, a lawyer for both families, said his clients want a policy change based on patients' relative conditions, not their ages.

"We're seeking that the system allocate a lung to Javier based on the severity of his condition," Harvey said. "So if there's an adult who's more severe than him, that adult gets the lung. We're not asking to jump to the front of the l ine."

The executive committee of the Organ Transplant Network is due to meet on Monday, at which time it could announce a review of the transplant rules. Failing that, a hearing to review the restraining order is scheduled for June 14 before Judge Baylson.

It was unclear how many children would be affected by a shift in rules. Harvey said there are 16 children aged from 5 to 10 currently seeking lung transplants, and that 23 such procedures were performed on children in 2011.

(Editing by Steve Gorman and Eric Walsh)

Obama Promotes Health Care to California; New Plans Begin on October 1

Obama Promotes Health Care to California; New Plans Begin on October 1

Obama Promotes Health Care to California; New Plans Begin on October 1

By Julie S | Jun 08, 2013 09:13 AM EDT

U.S President Barack Obama gave a speech to the Californians announcing his healthcare policy changes effective October 1.

"If you're one of 6 million Californians or tens of millions Americans who don't currently have health insurance, you'll soon be able to buy quality, affordable care just like everybody else," said Obama during his speech in San Jose, CA.

Despite the criticisms that the Affordable Care Act is not really affordable, the president was firm that it is valuable to the Americans. The act, also known as Obamacare, was implemented since 2010 regulating the healthcare system of the country. T

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he objective was to increase the coverage and cut the overall costs of health care to make it affordable for the general public. To date, there are already 21 provisions under this law with 10 of it already in place and 11 future-dated. Full provision will be completed by 2020.

The provision that will be implemented on October 1 will allow people looking to buy individual health insurance to enroll in subsidized plans offered through state-based exchanges, with coverage beginning in January 2014.

California has the most Americans with about 12 percent of the U.S population as of 2012 based on the U.S Census Bureau database. The government believes that the state will play a significant role on the success of Obamacare if all uninsured will be able to purchase a healthcare plan.

Based on the records of California Healthcare Foundation in 2011, California had the most number of health uninsured people in the country and it continues to rise. Only 22 percent of people under age 65 have a healthcare insurance. To date, about 6 million residents don’t have insurance.

The healthcare supporters expect to have an additional 1 million enrollment for healthcare once the provision begins on Oct. 1. Opponents believe it's unlikely as the insurance prices will increase before then. Since May 23, it has been reported that the prices have increased by up to 146 percent which will cost a 40-year-old to pay between $40 to $300 per month for a mid-level plan, depending on the income and subsidies.

Komen foundation cancels breast cancer walk in 7 cities

Komen foundation cancels breast cancer walk in 7 cities

Nightly News   |  June 05, 2013

Donations to the Susan G. Komen Foundation have fallen ever since the charity’s brand was damaged when their founder tried to deny funds to Planned Parenthood. NBC’s Brian Williams reports.

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Komen cancels 3-Day walk in District, six other cities in 2014

Komen cancels 3-Day walk in District, six other cities in 2014

Spokeswoman Andrea Rader cited economic uncertainty and competition from other charities as factors in the decision â€" the same reasons Komen has cited for the drop in fundraising since founder Nancy Brinker sparked national headlines in February 2012 when she unsuccessfully attempted to deny funds to Planned Parenthood.

“Many participants have reported that enthusiasm for the series remains very high, but it is more difficult for people to donate at levels they had in the past,” the statement said. It said participation in the past four years has made it difficult to sustain the event in 14 cities. “We hope to one day return to a larger number of markets, but believe strongly that this adjustment will allow us to return the greatest amount of dollars to the cause at this time.”

The announcement does not affect the 3-Day events scheduled for this year or other Komen events or services. Komen’s Washington 3-Day walk for this year will take place beginning Oct. 11.

Komen will continue to host the 3-Day events in 2014 in Atlanta, Dallas-Fort Worth, Michigan, Philadelphia, San Diego, Seattle and Minneapolis-St. Paul.

But next year, in addition to dropping Washington, Komen will not host 3-Day events in Arizona, Boston, Chicago, Cleveland, the Tampa Bay area and San Francisco.

The 3-Day events, which require participants to raise at least $2,300, are top revenue sources but expensive to organize, according to people familiar with Komen’s fundraising. Participants walk about 20 miles each of three days.

The events also tend to attract the most dedicated supporters, many of whom also support Planned Parenthood and were among those most upset by the controversy, according to sources familiar with Komen’s fundraising.

By comparison, next year’s Avon Walk for Breast Cancer will take place in the same eight cities as the group’s 2013 events â€" Houston, Washington, Boston, Chicago, San Francisco, New York, Charlotte and Santa Barbara, Calif., an Avon spokeswoman said.

“Our participation levels are on par with last year,” she said. Avon’s walk in Washington, which took place this past May, raised $4.5 million, compared to $5 million in 2012.

Komen’s annual Race for the Cure in Washington took place a week later. It had fewer participants than in previous years â€" about 21,000 people, down from 27,000 last year and nearly 40,000 in 2011. The race raised $5 million in 2011, $2 million last year and about $1.5 million this year, although this year’s tally is not final.

The dip in fundraising forced Komen to tap its reserves last year to fund research and other g rants, angering some affiliates, according to a source familiar with fundraising.

Rader denied that affiliates were concerned. “I don’t think anybody was particularly upset,” she said. “We have fairly substantial reserves and we had to tap them to help with our mission.”

Several senior executives who were well regarded at Komen’s Dallas headquarters have left or announced their departures in recent months. They are British Robinson, who oversaw Komen’s global operations; Lynn Erdman, who oversaw community health; and Carol Corcoran, senior vice president for Komen’s 120 affiliates.

Rader said Robinson’s and Corcoran’s departures were for personal reasons, while Erdman’s was the result of a restructuring.

While many of senior executives and board members have left, founder Brinker remains in place. Her $684,717 salary in fiscal 2012 continues to draw criticism.

FDA panel revisits Avandia; likely too late for diabetes drug

FDA panel revisits Avandia; likely too late for diabetes drug

By Ransdell Pierson

Wed Jun 5, 2013 7:02am EDT

(Reuters) - A panel of medical advisers to the U.S. Food and Drug Administration will revive a six-year-old debate over the safety of GlaxoSmithKline Plc's Avandia diabetes drug, but the two-day meeting that starts on Wednesday is not expected to greatly boost sales of the onetime blockbuster product.

Avandia's U.S. patent lapsed in 2011, a year after the FDA heavily restricted its use due to ambiguity about possible increased risk of heart attack and stroke seen in a large trial called RECORD, as well as a review of dozens of other studies.

The drug, which was withdrawn from the market in Europe in 2010 and is taken now by only 3,000 Americans, was once the world's biggest-selling treatment for type 2 diabetes, with sales of $3.2 billion in 2006.

No generic drugmakers have introduced cheaper copycats in the U.S. market and Glaxo has said it has no plans to promote Avandia again, even if the panel of FDA medical advisers recommends lifting restrictions on sales of the drug.

"The FDA is putting significant resources behind this meeting, but even if they allow Avandia to return to full marketing strength, I don't think that would do much for Glaxo from a business standpoint," said Morningstar ana lyst Damien Conover.

Conover said there was only a "slight" chance that the meeting will prompt the FDA to greatly ease the sales restrictions.

"But if they do, that could signal that the FDA is a little more willing to accept more side effects than it has in the past," Conover said.

Glaxo has settled lawsuits filed by tens of thousands of U.S. patients who had taken Avandia and claimed Glaxo failed to inform them about risks. Several thousand other cases remain pending.

The RECORD safety trial was required by European regulators due to concerns that drugs in its class - called thiazolidinediones - could increase risk of heart failure.

The trial met its primary objective by showing that Avandia, when combined with either metformin or a member of an older class of diabetes pills called sulfonylureas, was at least as safe as the combination of metformin and a sulfonylurea.

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But the FDA clamped down on Avandia's use in September 2010 after most members of an FDA advisory panel voted that the RECORD data raised significant concerns that Avandia could indeed pose greater risk of heart attack and stroke than standard treatments, including Takeda Pharmaceutical Co's Actos (pioglitazone), another thiazolidinedione.

Although the FDA allowed Avandia to remain on the U.S. market, the agency commissioned the Duke Clinical Research Institute to analyze results of the RECORD trial to better assess Avandia's safety and to examine criticisms that the trial was poorly designed and its data was mishandled.

But the FDA on Monday, in a briefing document ahead of the two-day meeting this week, said the study's methods and analyses passed muster with the Duke group, part of Duke University's Medical School. Moreover, it said the group appeared to agree that Avandia was not associated in the RECORD trial with increased risk of heart attacks and stroke.

Avandia had been on a downhill slide since 2007, when Dr. Steven Nissen, head of cardiology at the Cleveland Clinic, reported results of a so-called meta-analysis in which data from 42 studies was pooled and analyzed. It showed a 43 percent increased risk of heart attack from Avandia.

Sales of Avandia, which was approved in 1999 and makes patients more sensitive to their own insulin, plunged following the negative publicity, and the FDA now requires heart-safety data for new diabetes drugs because of the Avandia experience.

Glaxo last July agreed to pay $3 billion to settle what U.S. officials called the largest case of healthcare fraud in U.S. history. The agreement resolved allegations that Glaxo failed through 2007 to provide the FDA safety data on Avandia, and that the company improperly marketed other drugs.

(Reporting By Ransdell Pierson in New York; Editing b y Tim Dobbyn)