Wednesday, July 31, 2013

BMJ editorial: India's research participant protection policy

BMJ editorial: India's research participant protection policy [ Back to EurekAlert! ] Public release date: 31-Jul-2013
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Contact: Leah Ramsay
lramsay@jhu.edu
202-642-9640
Johns Hopkins Medicine

Experts say action needed urgently to ensure new policy does not backfire

In an editorial published online today in BMJ, Johns Hopkins bioethicist Jeremy Sugarman and other experts warn that action is urgently needed to deal with possible unintended consequences of India's new policy protecting research participants.

Passed earlier this year, the Drugs and Cosmetics Act (First Amendment) Rules, was meant to mitigate ethical concerns with potential serious consequences for public health, as well as India's viability as a continued global leader in clinical research. However, Sugarman and his co-authors highlight specific concerns that could lead to the policy having the opposite effect, including a table of the policy's "Conditions attributable to clinical trial injury or death." One of these is "use of placebo in a placebo controlled trial," to which the authors respond that "placebos are not necessarily harmful. Indeed the use of a placebo is often the only way of truly assessing whether the agent under study is associated with undue risk or significant benefit."

Among the authors other concerns is the policy's call to compensate research participants for injury for "failure of investigational product to provide intended therapeutic benefit," arguing that the purpose of the trial is to determine just that.

The authors give short and anticipated long-term ramifications of the policy, noting that at least 35 collaborative research projects funded by the US National Institutes of Health have been suspended since March 2013, most investigating large scale public health problems. They also note that India is the main supplier of antiretrovirals to donor supported HIV treatment programs in developing countries, and the dramatic fall in clinical trial applications that is already taking place could have a ripple effect on the availability of registered drugs.

"It is essential that the unintended consequences of the new policy are dealt with effectively but rapidly," the authors write. "The relevance, impact, and quality of global health research have been greatly strengthened by engagement of Indian scientists and participation of Indian research volunteers. Advances in health research need India's leadership and participation."

###

Read the editorial in BMJ: http://www.bmj.com/content/347/bmj.f4841.pdf%2Bhtml

Jeremy Sugarman: http://www.bioethicsinstitute.org/people/jeremy-sugarman-4

About the Johns Hopkins Berman Institute of Bioethics:

One of the largest bioethics centers in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, nongovernmental organizations and private sector organizations to address and resolve ethical issues. Institute faculty members represent such disciplines as medicine, nursing, law, philosophy, public health and the social sciences. More information is available at http://www.bioethicsinstitute.org.


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BMJ editorial: India's research participant protection policy [ Back to EurekAlert! ] Public release date: 31-Jul-2013
[ | E-mail | Share Share ]

Contact: Leah Ramsay
lramsay@jhu.edu
202-642-9640
Johns Hopkins Medicine

Experts say action needed urgently to ensure new policy does not backfire

In an editorial published online today in BMJ, Johns Hopkins bioethicist Jeremy Sugarman and other experts warn that action is urgently needed to deal with possible unintended consequences of India's new policy protecting research participants.

Passed earlier this year, the Drugs and Cosmetics Act (First Amendment) Rules, was meant to mitigate ethical concerns with potential serious consequences for public health, as well as India's viability as a continued global leader in clinical research. However, Sugarman and his co-authors highlight specific concerns that could lead to the policy having the opposite effect, including a table of the policy's "Conditions attributable to clinical trial injury or death." One of these is "use of placebo in a placebo controlled trial," to which the authors respond that "placebos are not necessarily harmful. Indeed the use of a placebo is often the only way of truly assessing whether the agent under study is associated with undue risk or significant benefit."

Among the authors other concerns is the policy's call to compensate research participants for injury for "failure of investigational product to provide intended therapeutic benefit," arguing that the purpose of the trial is to determine just that.

The authors give short and anticipated long-term ramifications of the policy, noting that at least 35 collaborative research projects funded by the US National Institutes of Health have been suspended since March 2013, most investigating large scale public health problems. They also note that India is the main supplier of antiretrovirals to donor supported HIV treatment programs in developing countries, and the dramatic fall in clinical trial applications that is already taking place could have a ripple effect on the availability of registered drugs.

"It is essential that the unintended consequences of the new policy are dealt with effectively but rapidly," the authors write. "The relevance, impact, and quality of global health research have been greatly strengthened by engagement of Indian scientists and participation of Indian research volunteers. Advances in health research need India's leadership and participation."

###

Read the editorial in BMJ: http://www.bmj.com/content/347/bmj.f4841.pdf%2Bhtml

Jeremy Sugarman: http://www.bioethicsinstitute.org/people/jeremy-sugarman-4

About the Johns Hopkins Berman Institute of Bioethics:

One of the largest bioethics centers in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, nongovernmental organizations and private sector organizations to address and resolve ethical issues. Institute faculty members represent such disciplines as medicine, nursing, law, philosophy, public health and the social sciences. More information is available at http://www.bioethicsinstitute.org.


[ Back to EurekAlert! ] [ | E-mail | Share Share ]

?


AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.


Source: http://www.eurekalert.org/pub_releases/2013-07/jhm-bei073113.php

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Obama proposes 'grand bargain' for jobs

FILE - In this July 25, 2013 file photo, President Barack Obama gestures as he speaks at the Jacksonville Port in Jacksonville, Fla. President Barack Obama is extending a new proposal to Republicans that he hopes will break the political gridlock on budget negotiations, offering to cut corporate tax rates in exchange for job investments. (AP Photo/Susan Walsh, File)

FILE - In this July 25, 2013 file photo, President Barack Obama gestures as he speaks at the Jacksonville Port in Jacksonville, Fla. President Barack Obama is extending a new proposal to Republicans that he hopes will break the political gridlock on budget negotiations, offering to cut corporate tax rates in exchange for job investments. (AP Photo/Susan Walsh, File)

(AP) ? President Barack Obama is extending a new proposal to Republicans that he hopes will break the political gridlock on budget negotiations, offering to cut corporate tax rates in exchange for job investments.

White House officials say just because they're at an impasse with congressional Republicans over a grand bargain on reducing the deficit doesn't mean they shouldn't look for other areas of agreement. So Obama plans to use a trip to an Amazon.com distribution center in Chattanooga, Tenn., on Tuesday to propose a "grand bargain for middle-class jobs."

Obama long has called for a cut in corporate tax rates, but previously insisted such business tax reform be coupled with an individual tax overhaul. He's dropping that demand and says instead that he's open to the corporate tax cut that that businesses crave. But he wants it to be coupled with a significant investment on some sort of job creation program, such as manufacturing, infrastructure or community colleges.

House Speaker John Boehner's office said Obama's proposals were hardly a compromise.

"This proposal allows President Obama to support President Obama's position on taxes and President Obama's position on spending, while leaving small businesses and American families behind," Boehner spokesman Michael Steel said.

Congressional Republicans have long insisted on tying corporate and individual tax reform so that small business owners who use the individual tax code would be offered cuts along with large corporations.

Senior administration officials described the corporate tax proposal as the first new economic idea Obama plans to offer in the coming months, with budget deadlines looming in the fall. Administration officials wouldn't put a price tag on the proposal or say how much would be a "significant" investment in jobs since the dollar figures would be part of negotiations with Congress. But in an example from this year's State of the Union address, Obama proposed $50 billion to put Americans to work repairing roads and bridges and other construction jobs.

The officials said money to pay for the jobs creation would come from a one-time revenue boost from measures such as changing depreciation rules or having a one-time fee on earnings held overseas.

"As part of his efforts to focus Washington on the middle class, today in Tennessee the president will call on Washington to work on a grand bargain focused on middle-class jobs by pairing reform of the business tax code with a significant investment in middle-class jobs," Obama senior adviser Dan Pfeiffer said.

Obama planned to make his remarks from an Amazon fulfillment center in Chattanooga, one of more than a dozen warehouses operated by the world's largest online retailer, which announced Monday that it would increase hiring. The company said it would add 7,000 new jobs, including 5,000 more at U.S. distribution centers that currently employ about 20,000 workers who pack and ship customer orders. Amazon.com Inc. has been spending heavily on order fulfillment to help its business grow.

Obama planned to tour the packing floor of the Chattanooga warehouse, which opened in September 2011. It is one of the company's largest and newest facilities, with more than 1 million square feet ? the size of more than 28 football fields full of merchandise.

The plant was the source of tax controversy when it opened; Amazon originally was granted an indefinite waiver on collecting sales tax in a deal to bring two distribution centers to Tennessee. The state's retailers were outraged that they were put at a competitive disadvantage, and Amazon has agreed to start collecting Tennessee sales tax next year.

The White House said Obama wasn't visiting Amazon because of the company's position on taxes, but because it's an example of a successful American business growing and creating more jobs.

Obama proposed last year to overhaul corporate taxes by lowering rates from the current 35 percent to 28 percent, with an even lower effective tax rate of 25 percent for manufacturers. The U.S. has one of the highest corporate tax rates in the world, but many businesses avoid the full cost by taking advantage of deductions, credits and exemptions that Obama wants to eliminate.

Obama wants to do away with corporate tax benefits like oil and natural gas industry subsidies, special breaks for the purchase of private jets and certain corporate tax shelters. He also wants to impose a minimum tax on foreign earnings, a move opposed by multinational corporations and perhaps the most contentious provision in the president's plan.

And the president has made little progress toward getting Republicans to sign on to a "grand bargain" of tax increases and spending cuts to reduce the deficit.

When Obama unveiled the corporate tax plan last year, congressional Republicans called for even deeper cuts for the business world. His campaign rival, Mitt Romney, wanted a 25 percent corporate tax rate.

___

Follow Nedra Pickler on Twitter at http://www.twitter.com/nedrapickler

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/89ae8247abe8493fae24405546e9a1aa/Article_2013-07-30-US-Obama/id-6ecb4559a3154e8b9f2798cde56892d3

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US economy grows at 1.7 pct. pace in 2nd quarter

WASHINGTON (AP) ? The U.S. economy grew from April through June at a modest seasonally adjusted annual rate of 1.7 percent, as businesses spent more and the federal government cut less.

The Commerce Department said Wednesday that growth improved from a 1.1 percent rate in the January-March quarter, which was revised from an initial 1.8 percent rate.

While growth remains sluggish, the pickup was surprising as most economists predicted a far weaker second quarter. And it suggests the economy could accelerate later this year as businesses step up spending and the drag from steep government cuts fade.

The second quarter figure indicates "the recovery is gaining momentum," Paul Ashworth, an economist at Capital Economics, said in a note to clients.

Businesses increased their spending 4.6 percent in the second quarter after cutting by the same amount in the previous quarter. And spending on home construction grew 13.4 percent, in line with the previous quarter.

At the same time, the federal government cut spending only 1.5 percent after an 8.4 percent plunge in the first quarter. And state and local governments increased spending for the first time in a year.

The biggest part of the economy is consumer spending and that grew more slowly in the second quarter. And a surge in imports reduced growth by the most in three years.

Still, economists are hopeful consumer spending will rebound and growth could improve to around 2.5 percent in the third and fourth quarters.

There were signs in the report that companies expect demand to pick up. Businesses added to their stockpiles in the second quarter, which is typically a sign they foresee greater sales.

The government also released comprehensive revisions that updated the nation's gross domestic product, or GDP, over the last several decades. Those figures showed that the economy grew at a stronger 2.8 percent in 2012, up from an earlier estimate of 2.2 percent. Last year's first quarter was revised much higher, while the economy barely expanded in the fourth quarter.

GDP is the broadest measure of the nation's output of goods and services, including everything from manicures to industrial machinery.

Other recent data have been encouraging and suggest that growth will continue to improve.

Home construction, sales and prices have been growing since early last year. Americans purchased newly built homes in June at the fastest pace in five years. That's raised builder confidence to a seven-year high, which should lead to increases in construction and more jobs.

Overall hiring has accelerated this year. Employers have added an average of 202,000 jobs a month from January through June. That's up from 180,000 in the previous six months.

And auto sales topped 7.8 million in the first six months of 2013, the best first-half total since 2007. Analysts expect sales will stay strong for the rest of the year.

There are threats to the better outlook. Unemployment is still high at 7.6 percent, limiting consumer spending. And budget fights in Washington could lead to a government shutdown this fall, potentially disrupting the economy.

Federal Reserve officials have forecast better growth in the second half of the year. And Fed Chairman Ben Bernanke has said that the central bank could begin to scale back its bond purchases later this year if the economy strengthens. But Fed officials typically put greater weight on employment and inflation data than the GDP figures.

The Fed concludes a two-day policy meeting on Wednesday, at which point it could clarify its interest-rate policies.

Source: http://news.yahoo.com/us-economy-grows-1-7-pct-pace-2nd-123146477.html

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Tuesday, July 30, 2013

How Will The Affordable Care Act Impact Your Small Business ...

TROY (WWJ) ? Sorting out how the Affordable Care Act will impact your business can be complicated, but there are plenty of resources available to help you do that.

WWJ Newsradio 950 has partnered with Blue Cross Blue Shield of Michigan to provide free forums to help small business owners learn more about providing coverage for employees.

Khaled Kteily, a senior consultant with the management consulting firm Oliver Wyman, says?the first thing business owners must to is get informed.

?Step one is getting online, talking to an agent, finding the resources online and taking a step-by-step view to it ? ? Kteily?said. ?Am I a small business owner? Yes or no. That determines whether or not they?d be eligible for paying the penalty, potential for not offering coverage.?

If you are a small business owner with?fewer than 50 employees, you can learn more at a?seminars hosted by Blue Cross Blue Shield of Michigan in August and September.?Find a seminar and sign up at this link.?

(Others looking to get better-informed about the Affordable Care Act,?click here.)

Source: http://detroit.cbslocal.com/2013/07/30/how-will-the-affordable-care-act-impact-your-small-business/

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Central Texas residents look to higher power in battle against Walmart

by KENS 5 staff

KENS 5 SAN ANTONIO

Posted on July 29, 2013 at 9:02 AM

CIBOLO, TX --? Some residents fighting to keep a proposed Walmart from building in their neighborhood marched around with crosses and prayed for their community on Sunday.

Opponents have said building a Walmart close to Wiederstein Elementary school would bring crime, traffic and noise to the area.

Members of Everyday Christian Fellowship, which is nearby the proposed retail store, walked around the area with a large cross offering prayers for Cibolo leaders.

"We are beginning a series of prayers walks for to pray for the needs of the people of our community," said Cory Webb.

The lot Walmart is eyeing is private and zoned for commercial use.? Cibolo's city manager told WFAA sister station KENS 5 there is nothing they can do to stop Walmart from opening at the location but the city has proposed the retail giant pick a different part of town.

At a recent community meeting, Walmart officials presented the plan for the new store to residents detailing everything from landscaping to parking.?

?We know how to operate these stores and one of the things we do is communicate with the community, the school districts, the principal and the parents from these communities and we hope to do that here as well,? said Daniel Morales, Director of communications for Walmart Stores Inc..

If the proposed Walmart becomes reality, members of Everyday Christian Fellowship said they will adjust.?

"We want what God wants," Webb said.? "If that happens we are going to embrace it and do the best with it because a lot of things we don't have control over in our lives."

City officials have said they will continue to compromise with neighbors and Walmart on the details of the plan.
?

Source: http://www.wfaa.com/news/texas-news/217382321.html

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Monday, July 29, 2013

Report: Israel Bombs Another Syrian Weapons Convoy

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Source: http://www.thegatewaypundit.com/2013/07/report-israel-bombs-another-syrian-weapons-convoy/

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President Obama and Former Secretary of State Hillary Clinton news ? click to read

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Source: http://feeds.foxnews.com/~r/blogs/Gretawire/~3/cOZIlFelsk8/

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Selena Gomez Celebrates 21st Birthday?With Justin Bieber!

Selena Gomez Celebrates 21st Birthday…With Justin Bieber!

Selena Gomez 21st birthday partySelena Gomez celebrated her 21st birthday on Saturday, with her ex-boyfriend Justin Bieber surprising her by attending the event. Bieber arrived with his friends and bodyguards in his leopard-print Audi R8, carrying a single red rose. An insider said that when Selena saw him she “started to cry”. Another source said, “She was all over ...

Selena Gomez Celebrates 21st Birthday…With Justin Bieber! Stupid Celebrities Gossip Stupid Celebrities Gossip News

Source: http://stupidcelebrities.net/2013/07/selena-gomez-celebrates-21st-birthday-with-justin-bieber/

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Sunday, July 28, 2013

Packers QB @AaronRodgers12 says Brewers slugger Ryan Braun "lied to" him about PED use: http://t.co/lCGi6YXpp3 -JM #NFL #MLB - @AP


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Kanye West, known for his disdain of paparazzi, allegedly scuffled with a photogpraher outside LAX?Friday.

A witness said a paparazzo named Dano provoked the musician and new father who landed at Los Angeles International Airport earlier Friday.

"He wanted to record something and nothing was happening," witness Shamir Chantre said. "Maybe he wanted to get some action going on."

  • Paparrazo: "Can we talk to you? Why can't we talk to you?"

In the video, posted by TMZ, Dano tells Kanye, who is known for his dislike of paparazzi, that he doesn't want a fight, but Samir Chantre said that's exactly what it appears he wanted.

"I think he looked for it and he got it," the witness told NBC4.

Chantre had just returned from a vacation in Brazil when he saw half dozen paparazzi taking pictures of Kanye, but Chantre said there was one who stood out.

"There was one paparazzi in particular that was kind of saying some stuff," Chantre recalled.

  • Kanye:?"What you're trying to do is get me in trouble so I step off and then have to pay you $250,000."

Despite predicting the outcome, Kanye still went after Dano, who went down as the pair struggled for the camera. Kanye got into a waiting car while the paramedics were called for Dano.

"They put him in a wheelchair and he had his leg all stiff, but I don't think something happened," Chantre said. "I truly believe he was faking."

Christian Zimmerman works with Dano and says the video he recorded is "selling like crazy."

"Our photographer did nothing wrong and if this goes to court, Kanye will be in a lot of trouble," Zimmerman said.

The Los Angeles Police Department is investigating the fight.

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Source: http://bit.ly/18xtEDZ

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