Tuesday, November 22, 2011

Merck will pay $950M to settle Vioxx investigation (AP)

NEW YORK � The Department of Justice said Tuesday that drugmaker Merck will pay $950 million to resolve investigations into its marketing of the painkiller Vioxx.

The agency said Merck will pay $321.6 million in criminal fines and $628.4 million as a civil settlement agreement. It will also plead guilty to a misdemeanor charge that it marketed Vioxx as a treatment for rheumatoid arthritis before getting Food and Drug Administration approval.

The government will get $426.4 million from the settlement, and $202 million will be distributed to state Medicaid programs for 43 states and the District of Columbia.

Merck stopped selling Vioxx in September 2004 after evidence showed the drug doubled the risk of heart attack and stroke. In 2007 the company paid $4.85 billion to settle around 50,000 Vioxx-related lawsuits. The Justice Department said the settlement resolves allegations that Merck made false, unproven, or misleading statements about Vioxx's safety to increase sales and made false statements to Medicaid agencies about its safety.

Merck said the settlement does not constitute an admission of any liability or wrongdoing, and it said the government acknowledged that there was no basis to conclude that Merck's upper-level management was involved in the violations.

Merck also entered into an agreement about its sales, marketing, publication, and government pricing activities. The Justice Department said that agreement strengthens oversight of the company. It will require top officials to complete annual compliance certifications, and the company will post information about physician payments on its website.

The Whitehouse Station, N.J., company took a charge of $950 million in the third quarter of 2010 to cover the anticipated settlement payments.

Vioxx was approved by the FDA in May 1999, but the government did not initially approve the drug for use in rheumatoid arthritis. That meant doctors could write prescriptions for Vioxx for rheumatoid arthritis patients, but Merck could not promote the drug for that use. The Justice Department said Merck promoted Vioxx for rheumatoid arthritis for three years and continued to do so after getting an FDA warning letter in September 2001. The drug was approved as a treatment for rheumatoid arthritis in April 2002.



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Giving thanks helps your psychological outlook (AP)

WASHINGTON � Count your blessings this Thanksgiving. It's good for you.

While it seems pretty obvious that gratitude is a positive emotion, psychologists for decades rarely delved into the science of giving thanks. But in the last several years they have, learning in many experiments that it is one of humanity's most powerful emotions. It makes you happier and can change your attitude about life, like an emotional reset button.

Especially in hard times, like these.

Beyond proving that being grateful helps you, psychologists also are trying to figure out the brain chemistry behind gratitude and the best ways of showing it.

"Oprah was right," said University of Miami psychology professor Michael McCullough, who has studied people who are asked to be regularly thankful. "When you are stopping and counting your blessings, you are sort of hijacking your emotional system."

And he means hijacking it from out of a funk into a good place. A very good place. Research by McCullough and others finds that giving thanks is a potent emotion that feeds on itself, almost the equivalent of being victorious. It could be called a vicious circle, but it's anything but vicious.

He said psychologists used to underestimate the strength of simple gratitude: "It does make people happier ... It's that incredible feeling."

One of the reasons why gratitude works so well is that it connects us with others, McCullough said. That's why when you give thanks it should be more heartfelt and personal instead of a terse thank you note for a gift or a hastily run-through grace before dinner, psychologists say.

Chicago area psychologist and self-help book author Maryann Troiani said she starts getting clients on gratitude gradually, sometimes just by limiting their complaints to two whines a session. Then she eventually gets them to log good things that happened to them in gratitude journals: "Gratitude really changes your attitude and your outlook on life."

Gratitude journals or diaries, in which people list weekly or nightly what they are thankful for, are becoming regular therapy tools.

And in those journals, it is important to focus more on the people you are grateful for, said Robert Emmons, a psychology professor at the University of California, Davis. Concentrate on what life would be without the good things � especially people such as spouses � in your life and how you are grateful they are there, he said.

Grateful people "feel more alert, alive, interested, enthusiastic. They also feel more connected to others," said Emmons, who has written two books on the science of gratitude and often studies the effects of those gratitude diaries.

"Gratitude also serves as a stress buffer," Emmons said in an e-mail interview. "Grateful people are less likely to experience envy, anger, resentment, regret and other unpleasant states that produce stress."

Scientists are not just looking at the emotions behind gratitude but the nuts-and-bolts physiology as well.

Preliminary theories look at the brain chemistry and hormones in the blood and neurotransmitters in the brain that are connected to feelings of gratitude, Emmons said. And the left prefrontal cortex of the brain, which is also associated with positive emotions like love and compassion, seems to be a key spot, especially in Buddhist monks, Emmons said.

However it works in the brain, Emmons said there is little doubt that it works.

Emmons, who has conducted several studies on people from ages 12 to 80, including those with neuromuscular disease, asked volunteers to keep daily or weekly gratitude diaries. Another group listed hassles, and others just recorded random events. He noticed a significant and consistent difference. About three-quarters of the people studied who regularly counted their blessings scored higher in happiness tests and some even showed improvements in amounts of sleep and exercise.

Christopher Peterson of the University of Michigan studied different gratitude methods and found the biggest immediate improvement in happiness scores was among people who were given one week to write and deliver in person a letter of gratitude to someone who had been especially kind to them, but was never thanked. That emotional health boost was large, but it didn't last over the weeks and months to come.

Peterson also asked people to write down nightly three things that went well that day and why that went well. That took longer to show any difference in happiness scores over control groups, but after one month the results were significantly better and they stayed better through six months.

Peterson said it worked so well that he is adopted it in his daily life, writing from-the-heart thank you notes, logging his feelings of gratitude: "It was very beneficial for me. I was much more cheerful."

At the University of North Carolina, Sara Algoe studied the interaction between cancer patients and their support group, especially when acts of gratitude were made. Like Peterson, she saw the effects last well over a month and she saw the feedback cycle that McCullough described.

"It must be really powerful," Algoe said.

It has to be potent to combat gloom many may be feeling in such uncertain times.

There have been many Thanksgivings throughout history that might challenge society's ability to be grateful. The first Thanksgiving with the Pilgrims came after about half of the Plymouth colony died in the first year. Thanksgiving became a national holiday in the United States when Abraham Lincoln proclaimed it in 1863 during the Civil War, the deadliest war the country has ever known. And the holiday moved to the fourth Thursday in November during the tail end of the Great Depression.

Emmons actually encourages people to "think of your worst moments, your sorrows, your losses, your sadness and then remember that here you are, able to remember them. You got through the worst day of your life ... remember the bad things, then look to see where you are."

That grace amid difficulty motif may make this Thanksgiving especially meaningful, McCullough said.

"In order to be grateful for something, we have to remember that something good happened," Peterson said. "It's important to remind ourselves that the world doesn't always suck."

___

Online:

Robert Emmons: http://psychology.ucdavis.edu/labs/emmons/PWT/index.cfm

National Association of School Psychologists' tips on fostering gratitude in children: http://bit.ly/rHlqCz



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UN: AIDS epidemic stabilizing, still work to do (AP)

LONDON � The AIDS epidemic is leveling off and the number of people newly infected with the virus that causes it has remained unchanged since 2007, the United Nations said in a report Monday.

Critics say that the body's aim of wiping out the disease is overly optimistic, however, considering there is no vaccine, millions remain untreated and donations have slumped amid the economic crisis.

There were 2.7 million new HIV infections last year, approximately the same figure as in the three previous years, said the report from UNAIDS, the joint United Nations program on HIV and AIDS. The figures largely confirm earlier findings released by the group in June.

At the end of last year, there were about 34 million people with HIV, the virus that causes AIDS. While that is a slight rise from previous years, experts say that's due to people surviving longer. Last year, there were 1.8 million AIDS-related deaths, down from 1.9 million in 2009.

The outbreak continues to hit hardest in southern Africa. But while the number of new infections there has fallen by more than 26 percent since the peak in 1997, the virus is surging elsewhere.

In eastern Europe and central Asia, there has been a 250 percent jump in the number of people infected with HIV in the past decade, due largely to the spread among injecting drug users. In North America and western Europe, the outbreak "remains stubbornly steady," according to the report.

"It's looking promising, but the numbers are still at a scary level," said Sophie Harman, a global health expert at City University in London. She was not connected to the UNAIDS report.

In its strategy for the next few years, UNAIDS says it is working toward zero new HIV infections, zero discrimination and zero AIDS-related deaths. Harman said that was an admirable goal but wasn't sure it was achievable. "They need to get real," she said. "Maybe they need to aim high but if their main goal is eradication, it's highly unlikely that will ever happen."

Dr. Paul De Lay, deputy executive director of UNAIDS, acknowledged the idea of eliminating AIDS infections and deaths is "more of a vision for the future," and would likely not be accomplished without new tools like a vaccine, which could take several decades. Earlier this month, U.S. Secretary of State Hillary Clinton called for an AIDS-free generation and promised more money for programs in Africa.

De Lay said U.N. strategies will focus on more aggressive prevention and treatment policies, like treating people with HIV earlier. In Africa, people with HIV are not usually treated until their immune system reaches a certain threshold, and officials are now increasingly trying to start treatment before patients get too sick.

Future strategies might also include giving medicines to people at high risk even before they get infected. The World Health Organization is considering how to advise countries with major epidemics on giving drugs to healthy people vulnerable to catching the virus, such as prostitutes, gay men and injecting drug users, as a prevention method.

While studies have shown that could dramatically slow AIDS transmission, experts have voiced concerns about healthy people taking AIDS drugs, which have toxic side effects. It could also encourage drug resistance, and there are already millions of people in developing countries who qualify for treatment but are still waiting for it.

Sharonann Lynch, an HIV policy adviser at Doctors Without Borders, said many African countries are anxious to implement more aggressive strategies and that some are redrafting their guidelines even before official U.N. advice is available. But she said the financial crisis is affecting treatment and that enrollment in some clinics, like in Congo, have stalled or even been suspended. That could allow the epidemic to resurge.

"Just at the moment when we know how to manage HIV, we're hitting the brakes," Lynch said. "Without more investment, we'll be squandering the best chance we have of getting ahead of the new wave of infections."

___

Online:

http://www.unaids.org

http://www.msf.org



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