One Direction named MTV’s 2012 Artist of the Year

NEW YORK (AP) — They’re platinum. They’re fascinating. And now One Direction is MTV‘s 2012 Artist of the Year.

MTV says the fivesome is “the clear choice for the top spot” after a year that included two No. 1 albums, hits such as “What Makes You Beautiful” and a sold-out world tour.

One Direction’s Louis (LOO’-ee) Tomlinson calls Thursday’s honor “the icing on the cake.”

MTV’s team of music staffers chose Carly Rae Jepsen‘s “Call Me Maybe” as song as the year.

One Direction placed third on the U.K. version of “The X Factor” in 2010 and made their U.S. debut in March with the No. 1 album “Up All Night.” Their sophomore album, “Take Me Home,” was the year’s third-highest debut.

The group also made Barbara Walters’ most fascinating people of 2012 list.

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Study: People worldwide living longer, but sicker

LONDON (AP) — Nearly everywhere around the world, people are living longer and fewer children are dying. But increasingly, people are grappling with the diseases and disabilities of modern life, according to the most expansive global look so far at life expectancy and the biggest health threats.

The last comprehensive study was in 1990 and the top health problem then was the death of children under 5 — more than 10 million each year. Since then, campaigns to vaccinate kids against diseases like polio and measles have reduced the number of children dying to about 7 million.

Malnutrition was once the main health threat for children. Now, everywhere except Africa, they are much more likely to overeat than to starve.

With more children surviving, chronic illnesses and disabilities that strike later in life are taking a bigger toll, the research said. High blood pressure has become the leading health risk worldwide, followed by smoking and alcohol.

“The biggest contributor to the global health burden isn’t premature (deaths), but chronic diseases, injuries, mental health conditions and all the bone and joint diseases,” said one of the study leaders, Christopher Murray, director of the Institute of Health Metrics and Evaluation at the University of Washington.

In developed countries, such conditions now account for more than half of the health problems, fueled by an aging population. While life expectancy is climbing nearly everywhere, so too are the number of years people will live with things like vision or hearing loss and mental health issues like depression.

The research appears in seven papers published online Thursday by the journal Lancet. More than 480 researchers in 50 countries gathered data up to 2010 from surveys, censuses and past studies. They used statistical modeling to fill in the gaps for countries with little information. The series was mainly paid for by the Bill & Melinda Gates Foundation.

As in 1990, Japan topped the life expectancy list in 2010, with 79 for men and 86 for women. In the U.S. that year, life expectancy for men was 76 and for women, 81.

The research found wide variations in what’s killing people around the world. Some of the most striking findings highlighted by the researchers: — Homicide is the No. 3 killer of men in Latin America; it ranks 20th worldwide. In the U.S., it is the 21st cause of death in men, and in Western Europe, 57th.

— While suicide ranks globally as the 21st leading killer, it is as high as the ninth top cause of death in women across Asia’s “suicide belt,” from India to China. Suicide ranks 14th in North America and 15th in Western Europe.

— In people aged 15-49, diabetes is a bigger killer in Africa than in Western Europe (8.8 deaths versus 1 death per 100,000).

— Central and Southeast Asia have the highest rates of fatal stroke in young adults at about 15 cases per 100,000 deaths. In North America, the rate is about 3 per 100,000.

Globally, heart disease and stroke remain the top killers. Reflecting an older population, lung cancer moved to the 5th cause of death globally, while other cancers including those of the liver, stomach and colon are also in the top 20. AIDS jumped from the 35th cause of death in 1990 to the sixth leading cause two decades later.

While chronic diseases are killing more people nearly everywhere, the overall trend is the opposite in Africa, where illnesses like AIDS, malaria and tuberculosis are still major threats. And experts warn again shifting too much of the focus away from those ailments.

“It’s the nature of infectious disease epidemics that if you turn away from them, they will crop right back up,” said Jennifer Cohn, a medical coordinator at Doctors Without Borders.

Still, she acknowledged the need to address the surge of other health problems across Africa. Cohn said the agency was considering ways to treat things like heart disease and diabetes. “The way we treat HIV could be a good model for chronic care,” she said.

Others said more concrete information is needed before making any big changes to public health policies.

“We have to take this data with some grains of salt,” said Sandy Cairncross, an epidemiologist at the London School of Hygiene and Tropical Medicine.

He said the information in some of the Lancet research was too thin and didn’t fully consider all the relevant health risk factors.

“We’re getting a better picture, but it’s still incomplete,” he said.

___

Online:

www.lancet.com

http://healthmetricsandevaluation.org

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Study: People worldwide living longer, but sicker

LONDON (AP) — Nearly everywhere around the world, people are living longer and fewer children are dying. But increasingly, people are grappling with the diseases and disabilities of modern life, according to the most expansive global look so far at life expectancy and the biggest health threats.

The last comprehensive study was in 1990 and the top health problem then was the death of children under 5 — more than 10 million each year. Since then, campaigns to vaccinate kids against diseases like polio and measles have reduced the number of children dying to about 7 million.

Malnutrition was once the main health threat for children. Now, everywhere except Africa, they are much more likely to overeat than to starve.

With more children surviving, chronic illnesses and disabilities that strike later in life are taking a bigger toll, the research said. High blood pressure has become the leading health risk worldwide, followed by smoking and alcohol.

“The biggest contributor to the global health burden isn’t premature (deaths), but chronic diseases, injuries, mental health conditions and all the bone and joint diseases,” said one of the study leaders, Christopher Murray, director of the Institute of Health Metrics and Evaluation at the University of Washington.

In developed countries, such conditions now account for more than half of the health problems, fueled by an aging population. While life expectancy is climbing nearly everywhere, so too are the number of years people will live with things like vision or hearing loss and mental health issues like depression.

The research appears in seven papers published online Thursday by the journal Lancet. More than 480 researchers in 50 countries gathered data up to 2010 from surveys, censuses and past studies. They used statistical modeling to fill in the gaps for countries with little information. The series was mainly paid for by the Bill & Melinda Gates Foundation.

As in 1990, Japan topped the life expectancy list in 2010, with 79 for men and 86 for women. In the U.S. that year, life expectancy for men was 76 and for women, 81.

The research found wide variations in what’s killing people around the world. Some of the most striking findings highlighted by the researchers: — Homicide is the No. 3 killer of men in Latin America; it ranks 20th worldwide. In the U.S., it is the 21st cause of death in men, and in Western Europe, 57th.

— While suicide ranks globally as the 21st leading killer, it is as high as the ninth top cause of death in women across Asia’s “suicide belt,” from India to China. Suicide ranks 14th in North America and 15th in Western Europe.

— In people aged 15-49, diabetes is a bigger killer in Africa than in Western Europe (8.8 deaths versus 1 death per 100,000).

— Central and Southeast Asia have the highest rates of fatal stroke in young adults at about 15 cases per 100,000 deaths. In North America, the rate is about 3 per 100,000.

Globally, heart disease and stroke remain the top killers. Reflecting an older population, lung cancer moved to the 5th cause of death globally, while other cancers including those of the liver, stomach and colon are also in the top 20. AIDS jumped from the 35th cause of death in 1990 to the sixth leading cause two decades later.

While chronic diseases are killing more people nearly everywhere, the overall trend is the opposite in Africa, where illnesses like AIDS, malaria and tuberculosis are still major threats. And experts warn again shifting too much of the focus away from those ailments.

“It’s the nature of infectious disease epidemics that if you turn away from them, they will crop right back up,” said Jennifer Cohn, a medical coordinator at Doctors Without Borders.

Still, she acknowledged the need to address the surge of other health problems across Africa. Cohn said the agency was considering ways to treat things like heart disease and diabetes. “The way we treat HIV could be a good model for chronic care,” she said.

Others said more concrete information is needed before making any big changes to public health policies.

“We have to take this data with some grains of salt,” said Sandy Cairncross, an epidemiologist at the London School of Hygiene and Tropical Medicine.

He said the information in some of the Lancet research was too thin and didn’t fully consider all the relevant health risk factors.

“We’re getting a better picture, but it’s still incomplete,” he said.

___

Online:

www.lancet.com

http://healthmetricsandevaluation.org

Health News Headlines – Yahoo! News

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Xi Jinping Hits the Ground Running

Barely a month after becoming party secretary, Xi Jinping has been busy showing who’s in charge. He has stepped up a crackdown on corruption, ordered officials to cut down on pomp and ceremony, called for improved relations with the rest of the world, and pushed for a stronger military. On his first official trip outside Beijing, Xi, who should assume the presidency in March, visited the freewheeling province of Guangdong, where he met with entrepreneurs and called for speedier economic reform. There he evoked the vision of paramount leader Deng Xiao-ping, who launched China’s opening to the world some 30 years ago and who traveled to Guangdong in 1992 to energize reforms.

After a decade of relative stasis under outgoing leaders Hu Jintao and Wen Jiabao, many China watchers are surprised and encouraged by Xi’s boldness. “For Xi to do so much so quickly is quite unprecedented. In the one-party system everyone is supposed to give the feeling that all is continuity and passing the baton. It is almost impolite to make changes too quickly,” says Robert Lawrence Kuhn, author of How China’s Leaders Think.

Reining in corruption seems to be the top goal. “Corruption could kill the party and ruin the country,” Xi warned top leaders in a meeting on Nov. 18, reported the official English-language China Daily. Under Xi’s watch, state media are encouraging whistle-blowers to use the Internet to report graft. The government has announced a trial program in Guangdong that will require officials and their families to report their assets regularly. Xi also has ordered the investigation of a senior provincial official in Sichuan suspected of financial improprieties. “The government is placing a lot more officials under scrutiny now,” says David Kelly, research director at China Policy, a Beijing-based research and advisory company. “But the question is not just whether individual officials are corrupt. It is an endemic problem.” He cites as an example the practice of government positions being sold, a problem highlighted in a recent report by the Central Commission for Discipline Inspection.

Xi’s order that officials should limit the lavish displays that usually accompany their public appearances is meant to show that the leadership is more in tune with the people. “You can give an edict like this, and there will be visible changes immediately,” says Kuhn. “The hope is that people will see them and that will give the leaders street cred so they can continue working on harder things.” Xi has also mandated that government meetings be shorter and that “empty talk”—jargon-laden and long-winded speeches—be avoided, according to a commentary by the official Xinhua News Agency on the new rules.

Xi is more comfortable than Hu in dealing with his foreign counterparts, says Douglas Paal, vice president for studies at the Carnegie Endowment for International Peace. “He exudes confidence,” says Paal, who served on the National Security Council under Presidents Ronald Reagan and George H.W. Bush. In a December meeting with foreign scholars working in China, Xi stressed the need for closer relations with the world, saying no country “can go it alone or outshine others in today’s complex global economy,” Xinhua reported.

Xi’s strong ties with an assertive military (his father was a venerated revolutionary guerrilla, and Xi once served as an assistant to an important defense official) could create friction with Asia and the U.S. Since becoming head of the central military commission, a post he assumed when he became party secretary, Xi has met with top brass and promoted to full general the commander of the Second Artillery Corps, which is responsible for China’s nuclear arsenal. “The People’s Liberation Army has been ordered to build a powerful missile force,” reported Xinhua on Dec. 5.

Any of Xi’s efforts to stamp out corruption or weaken the clout of state-owned enterprises are likely to run up against well-entrenched business elites. These include the so-called princelings, the offspring of senior leaders. “Of course Xi wants to send a message saying ‘I will follow Deng Xiaoping’s reform,’ ” says Bo Zhiyue, a professor and senior research fellow at the East Asian Institute of the National University of Singapore. “But that in itself doesn’t mean anything.” Bo cites Premier Wen Jiabao as an official who stressed the importance of reform but accomplished little. “In China, being a reformer is politically correct. Everyone is a reformer because they have to be.”

The bottom line: Even before assuming the presidency, Xi Jinping has signaled he’ll be aggressive about reforms.

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Cuban lawmakers meet to consider economy, budget

HAVANA (AP) — Cuban lawmakers are holding the second of their twice-annual sessions with a year-end report expected on the state of the country’s economy.

Legislators are also to approve next year’s budget.

Cuban leaders have sometimes used the parliamentary gatherings to make important announcements or policy statements.

Observers will be watching for word on the progress of President Raul Castro‘s economic reform plan and efforts to promote younger leaders.

The unicameral parliament will reconvene in February with a new membership following elections. It is then expected to name Castro to another five-year term.

State-run media said Castro presided over Thursday’s session.

It was not open to international journalists.

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Facebook, Google tell the government to stop granting patents for abstract ideas

Facebook (FB), Google (GOOG) and six other tech companies have petitioned the courts to begin rejecting lawsuits that are based on patents for vague concepts rather than specific applications, TechCrunch reported. The agreement, which was cosigned by Zynga (ZNGA), Dell (DELL), Intuit (INTU), Homeaway (AWAY), Rackspace (RAX), and Red Hat (RHT), notes the only thing these abstract patents do is increase legal fees and slow innovation in the industry. The companies claim that “abstract patents are a plague in the high tech sector” and force innovators into litigation that results in huge settlements or steep licensing fees for technology they have already developed on their own, which then leads to higher prices for consumers.

“Many computer-related patent claims just describe an abstract idea at a high level of generality and say to perform it on a computer or over the Internet,” the briefing reads. “Such barebones claims grant exclusive rights over the abstract idea itself, with no limit on how the idea is implemented. Granting patent protection for such claims would impair, not promote, innovation by conferring exclusive rights on those who have not meaningfully innovated, and thereby penalizing those that do later innovate by blocking or taxing their applications of the abstract idea.”

The companies conclude, “It is easy to think of abstract ideas about what a computer or website should do, but the difficult, valuable, and often groundbreaking part of online innovation comes next: designing, analyzing, building, and deploying the interface, software, and hardware to implement that idea in a way that is useful in daily life. Simply put, ideas are much easier to come by than working implementations.”

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Music, comedy strike defiant tone at Sandy concert

NEW YORK (AP) — Music and comedy royalty struck a defiant tone in a benefit concert for Superstorm Sandy victims on Wednesday, asking for help to rebuild a New York metropolitan area most of them know well.

The sold-out Madison Square Garden show was televised, streamed online and aired on radio all over the world. Producers said up to 2 billion people could experience the concert live.

“When are you going to learn,” comic and New Jersey native Jon Stewart said. “You can throw anything at us — terrorists, hurricanes. You can take away our giant sodas. It doesn’t matter. We’re coming back stronger every time.”

Jersey shore hero Bruce Springsteen set a roaring tone, opening the concert with “Land of Hope and Dreams” and “Wrecking Ball.” He addressed the rebuilding process in introducing his song “My City of Ruins,” noting it was written about the decline of Asbury Park, N.J. before that city’s renaissance over the past decade. What made the Jersey shore special was its inclusiveness, a place where people of all incomes and backgrounds could find a place, he said.

“I pray that that characteristic remains along the Jersey shore because that’s what makes it special,” Springsteen said.

He mixed a verse of Tom Waits’ “Jersey Girl” into the song before calling New Jersey neighbor Jon Bon Jovi to join him in a rousing “Born to Run.” Springsteen later returned the favor by joining Bon Jovi on “Who Says You Can’t Go Home.”

Adam Sandler hearkened back to his “Saturday Night Live” days with a ribald rewrite of the oft-sung “Hallelujah” that composer Leonard Cohen never would have dreamed. The rewritten chorus says, “Sandy, screw ya, we’ll get through ya, because we’re New Yawkers.

Sandler wore a New York Jets T-shirt and mined Donald Trump, Michael Bloomberg, the New York Knicks, Times Square porn and Jets quarterback Mark Sanchez for laugh lines.

The music lineup was heavily weighted toward classic rock, which has the type of fans able to afford a show for which ticket prices ranged from $ 150 to $ 2,500. Even with those prices, people with tickets have been offering them for more on broker sites such as StubHub, an attempt at profiteering that producers fumed was “despicable.”

“This has got to be the largest collection of old English musicians ever assembled in Madison Square Garden,” Rolling Stones rocker Mick Jagger said. “If it rains in London, you’ve got to come and help us.”

In fighting trim for a series of 50th anniversary concerts in the New York area, the Stones ripped through “You’ve Got Me Rockin’” and “Jumping Jack Flash.

Jagger wasn’t in New York City for Sandy, but he said in an interview before the concert that his apartment was flooded with 2 feet of water.

Eric Clapton switched from acoustic to electric guitar and sang “Nobody Knows You When You’re Down and Out” and “Crossroads.” New York was a backdrop for Clapton’s personal tragedy, when his young son died after falling out of a window.

Roger Waters played a set of Pink Floyd’s spacey rock, joined by Eddie Vedder for “Comfortably Numb.” Waters stuck to the music and left the fundraising to others.

“Can’t chat,” he said, “because we only have 30 minutes.”

The sold-out “12-12-12″ concert was being shown on 37 television stations in the United States and more than 200 others worldwide. It was to be streamed on 30 websites, including YouTube and Yahoo, and played on radio stations. Theaters, including 27 in the New York region and dozens more elsewhere, were showing it live.

Proceeds from the show will be distributed through the Robin Hood Foundation. More than $ 30 million was raised through ticket sales alone.

The powerful storm left parts of New York City underwater and left millions of people in several states without heat or electricity for weeks. It’s blamed for at least 125 deaths, including 104 in New York and New Jersey, and it destroyed or damaged 305,000 housing units in New York alone.

Other concert performers were to include Long Islander Billy Joel (“New York State of Mind”) and New Yorker Alicia Keys (“Empire State of Mind”). Even Liverpool’s Paul McCartney has a New York office, Hamptons home and a wife, Nancy Shevell, who spent a decade on the board of the agency that runs New York‘s public transit system.

E Street Band guitarist Steve Van Zandt said backstage that musicians are often quick to help when they can.

“Yes, it’s more personal because literally the Jersey shore is where we grew up,” he said. “But we’d be here anyway.”

The concert came a day after the death of sitar master Ravi Shankar, a performer at the 1971 “Concert for Bangladesh” considered the grandfather of music benefits. That concert also was in Madison Square Garden.

___

AP Music Writer Mesfin Fekadu in New York contributed to this report.

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Advancing the Promise of Personalized Medicine: Companion Diagnostics

When I was a sophomore in college, my mother unfortunately lost her very short battle with pancreatic cancer, an experience that changed my life forever. During that time I witnessed firsthand the devastating effects caused by the administration of toxic, non-specific treatments which ultimately failed to stop the spread of the cancer, and instead only made my mother extremely sick. Her death, at the young age of 44, profoundly influenced my feelings towards medicine and altered my career path. As a result, I became driven to discover better drugs for treating cancer, with a focus to specifically target diseased cells while leaving healthy tissues unharmed.Thankfully, my passion for developing smarter cancer drugs is shared by many others, and it has been exciting to see the progress made over the years in developing treatments that can be characterized as “personalized medicines”. A commonly cited example that demonstrates the impact of personalized medicine in cancer is the successful development of the breast cancer drug, Herceptin(R), which specifically targets aggressive HER2-positive breast cancer. Importantly, before this medication was developed, women with HER2-expressing breast cancer were less responsive to standard treatments. Now, however, treatment with Herceptin in combination with chemotherapy has amazingly been shown to reduce the recurrence rate of this type of cancer by 52 percent.Building on Biomarkers: Companion DiagnosticsA biomarker is a unique trait of a disease, such as genetic marker or overexpressed protein like HER2. Developing a medicine that targets a specific biomarker can have a positive effect on patient outcome, but this approach is only one part of the therapeutic equation. To truly fulfill the promise of personalized medicine, there must also be a tool available for identifying those patients bearing that biomarker. An agent of this type is called a companion diagnostic. The outcome of this type of test should enable the right drug to be administered, to the right person, at the right time. In this manner, a companion diagnostic helps to identify those patients that may benefit from a given targeted treatment while at the same time identifying patients that will likely not benefit from therapy. Related to the example above, such a test is available to determine if a patient has HER2-positive breast cancer, and it is performed before Herceptin is prescribed.Recently, due to the benefits realized from biomarker testing, interest in developing companion diagnostics has surged. The FDA is very supportive of the development of these patient-selective tests. In fact, one companion diagnostic was approved this year and two within the same month last year to accompany Pfizer’s targeted drug for lung cancer, Xalkori(R), and Roche’s personalized therapeutic for melanoma, Zelboraf(R). Importantly, Roche stated that it aims to have 60 percent of its drugs in development to be accompanied by some form of a companion test, an indication that, like the FDA, the pharmaceutical industry is also embracing the continued development of companion diagnostic agents.There are many reasons for the significant interest in this space that stem from the benefits of identifying patients with companion diagnostics. For example, in the area of cancer, where development of these agents is most advanced, significant delay of tumor growth and increased survival rates have been demonstrated in patients that were preselected using a companion diagnostic. Having the ability to determine whether a patient may or may not respond to a given treatment enables the selection of the best medicine for that individual, without wasting precious time with trial and error approaches.It is precisely this advantage that allows clinical trials to be conducted in a specific patient population, which can decrease the size and related cost of these studies. Lower costs may allow drug developers to use such savings to invest in additional areas of disease research. Furthermore, smaller clinical trial size means that studies can be conducted more quickly, which could accelerate the arrival of these treatments to the market and broaden access to patients. Collectively, these conserved resources translate into savings for the entire healthcare system, which is an important benefit as rising healthcare costs are a significant issue for our nation.It is worth noting that a recent paper published in the New England Journal of Medicine showed that the genetic characteristics of a tumor, such as biomarker expression, can and often do change over time. Thus, in contrast to conventional companion diagnostics that typically utilize tissue samples obtained through biopsy (especially those performed on archived tissue), additional benefits are found with the use of companion diagnostics that are based on whole-body imaging. Results obtained from non-invasive, real-time imaging methodology, therefore, provide the most up-to-date biomarker information possible to inform treatment decision making. But, regardless of the method employed, the impact of patient selection can be substantial.A New ApproachAt Endocyte, we have seen this patient-selective approach translate into positive clinical results. The technology we’re developing consists of targeted therapeutics called small molecule drug conjugates, or SMDCs. Each of these novel compounds consists of a high affinity, cell-specific targeting molecule (the ligand) that is chemically linked to a potent chemotherapy drug. This yields a highly potent, yet selective therapeutic agent; but, this approach also allows us to easily create a companion diagnostic by simply replacing the chemotherapeutic drug in the SMDC construct with an imaging agent.Vintafolide is our most advanced SMDC in development. This therapeutic binds to the folate receptor, which is a confirmed biomarker expressed on many human cancers, including ovarian, lung, breast and colon. Vintafolide’s companion diagnostic imaging agent (etarfolatide) is designed to identify cancer patients that have high levels of the folate receptor expression, which is the exact population of patients expected to respond to this drug.In a previous clinical trial in patients with platinum-resistant ovarian cancer, women identified as “FR-positive” by etarfolatide and then subsequently treated with vintafolide had significantly delayed tumor growth. Based on these unprecedented results, especially in a patient population that fails to adequately respond to any therapy, both etarfolatide and vintafolide are being considered for conditional approval in Europe. This could mean that patients would have access to these agents much sooner than expected. Overall, this exciting opportunity would never have been possible if our companion diagnostic agent was not used to select the right patient population to treat with vintafolide in our clinical trials.A Promising FutureBecause of the numerous benefits companion diagnostics hold for patients, physicians, drug developers and our healthcare system, their continued development and use will only increase in the future. Regulatory agencies worldwide are also embracing this approach, and they continue to encourage drug developers to pursue this path for the treatment of all types of diseases. As the number of companion diagnostics in development continues to grow, we are moving closer each day to truly fulfilling the promise of personalized medicine.

Follow Scientific American on Twitter @SciAm and @SciamBlogs.Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.
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Advancing the Promise of Personalized Medicine: Companion Diagnostics

When I was a sophomore in college, my mother unfortunately lost her very short battle with pancreatic cancer, an experience that changed my life forever. During that time I witnessed firsthand the devastating effects caused by the administration of toxic, non-specific treatments which ultimately failed to stop the spread of the cancer, and instead only made my mother extremely sick. Her death, at the young age of 44, profoundly influenced my feelings towards medicine and altered my career path. As a result, I became driven to discover better drugs for treating cancer, with a focus to specifically target diseased cells while leaving healthy tissues unharmed.Thankfully, my passion for developing smarter cancer drugs is shared by many others, and it has been exciting to see the progress made over the years in developing treatments that can be characterized as “personalized medicines”. A commonly cited example that demonstrates the impact of personalized medicine in cancer is the successful development of the breast cancer drug, Herceptin(R), which specifically targets aggressive HER2-positive breast cancer. Importantly, before this medication was developed, women with HER2-expressing breast cancer were less responsive to standard treatments. Now, however, treatment with Herceptin in combination with chemotherapy has amazingly been shown to reduce the recurrence rate of this type of cancer by 52 percent.Building on Biomarkers: Companion DiagnosticsA biomarker is a unique trait of a disease, such as genetic marker or overexpressed protein like HER2. Developing a medicine that targets a specific biomarker can have a positive effect on patient outcome, but this approach is only one part of the therapeutic equation. To truly fulfill the promise of personalized medicine, there must also be a tool available for identifying those patients bearing that biomarker. An agent of this type is called a companion diagnostic. The outcome of this type of test should enable the right drug to be administered, to the right person, at the right time. In this manner, a companion diagnostic helps to identify those patients that may benefit from a given targeted treatment while at the same time identifying patients that will likely not benefit from therapy. Related to the example above, such a test is available to determine if a patient has HER2-positive breast cancer, and it is performed before Herceptin is prescribed.Recently, due to the benefits realized from biomarker testing, interest in developing companion diagnostics has surged. The FDA is very supportive of the development of these patient-selective tests. In fact, one companion diagnostic was approved this year and two within the same month last year to accompany Pfizer’s targeted drug for lung cancer, Xalkori(R), and Roche’s personalized therapeutic for melanoma, Zelboraf(R). Importantly, Roche stated that it aims to have 60 percent of its drugs in development to be accompanied by some form of a companion test, an indication that, like the FDA, the pharmaceutical industry is also embracing the continued development of companion diagnostic agents.There are many reasons for the significant interest in this space that stem from the benefits of identifying patients with companion diagnostics. For example, in the area of cancer, where development of these agents is most advanced, significant delay of tumor growth and increased survival rates have been demonstrated in patients that were preselected using a companion diagnostic. Having the ability to determine whether a patient may or may not respond to a given treatment enables the selection of the best medicine for that individual, without wasting precious time with trial and error approaches.It is precisely this advantage that allows clinical trials to be conducted in a specific patient population, which can decrease the size and related cost of these studies. Lower costs may allow drug developers to use such savings to invest in additional areas of disease research. Furthermore, smaller clinical trial size means that studies can be conducted more quickly, which could accelerate the arrival of these treatments to the market and broaden access to patients. Collectively, these conserved resources translate into savings for the entire healthcare system, which is an important benefit as rising healthcare costs are a significant issue for our nation.It is worth noting that a recent paper published in the New England Journal of Medicine showed that the genetic characteristics of a tumor, such as biomarker expression, can and often do change over time. Thus, in contrast to conventional companion diagnostics that typically utilize tissue samples obtained through biopsy (especially those performed on archived tissue), additional benefits are found with the use of companion diagnostics that are based on whole-body imaging. Results obtained from non-invasive, real-time imaging methodology, therefore, provide the most up-to-date biomarker information possible to inform treatment decision making. But, regardless of the method employed, the impact of patient selection can be substantial.A New ApproachAt Endocyte, we have seen this patient-selective approach translate into positive clinical results. The technology we’re developing consists of targeted therapeutics called small molecule drug conjugates, or SMDCs. Each of these novel compounds consists of a high affinity, cell-specific targeting molecule (the ligand) that is chemically linked to a potent chemotherapy drug. This yields a highly potent, yet selective therapeutic agent; but, this approach also allows us to easily create a companion diagnostic by simply replacing the chemotherapeutic drug in the SMDC construct with an imaging agent.Vintafolide is our most advanced SMDC in development. This therapeutic binds to the folate receptor, which is a confirmed biomarker expressed on many human cancers, including ovarian, lung, breast and colon. Vintafolide’s companion diagnostic imaging agent (etarfolatide) is designed to identify cancer patients that have high levels of the folate receptor expression, which is the exact population of patients expected to respond to this drug.In a previous clinical trial in patients with platinum-resistant ovarian cancer, women identified as “FR-positive” by etarfolatide and then subsequently treated with vintafolide had significantly delayed tumor growth. Based on these unprecedented results, especially in a patient population that fails to adequately respond to any therapy, both etarfolatide and vintafolide are being considered for conditional approval in Europe. This could mean that patients would have access to these agents much sooner than expected. Overall, this exciting opportunity would never have been possible if our companion diagnostic agent was not used to select the right patient population to treat with vintafolide in our clinical trials.A Promising FutureBecause of the numerous benefits companion diagnostics hold for patients, physicians, drug developers and our healthcare system, their continued development and use will only increase in the future. Regulatory agencies worldwide are also embracing this approach, and they continue to encourage drug developers to pursue this path for the treatment of all types of diseases. As the number of companion diagnostics in development continues to grow, we are moving closer each day to truly fulfilling the promise of personalized medicine.

Follow Scientific American on Twitter @SciAm and @SciamBlogs.Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.
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Fed ties rates to jobs recovery, adds to stimulus

WASHINGTON (Reuters) – The U.S. Federal Reserve, announcing a new round of monetary stimulus, took the unprecedented step on Wednesday of indicating interest rates would remain near zero until unemployment falls to at least 6.5 percent.

It was the latest in a series of unorthodox measures taken by central banks around the world to battle erratic, sub-par recoveries from the financial crisis and recession of 2007-2009.

The Fed expects to hold rates steady until its new threshold on unemployment was reached as long as inflation does not threaten to break above 2.5 percent and inflation expectations are contained. It also replaced an expiring stimulus program with a fresh round of Treasury debt purchases.

The central bank previously said it expected to hold rates near zero through at least mid-2015, but policymakers were uncomfortable making a pledge based on the calendar rather than the economic goals they hope to achieve.

“By tying future monetary policy more explicitly to economic conditions, this formulation of our policy guidance should … make monetary policy more transparent and predictable to the public,” Fed Chairman Ben Bernanke told a news conference.

Importantly, in the eyes of Fed officials, the new framework should help financial markets assess incoming data in a way that helps them better guess were monetary policy is heading.

Right now, the Fed is engaged in an open-ended program of asset purchases, which it bolstered on Wednesday.

Officials committed to buy $ 45 billion in longer-term Treasuries each month on top of the $ 40 billion per month in mortgage-backed bonds they started purchasing in September. They repeated a pledge to keep pumping money into the economy until the outlook for the labor market improves “substantially.”

“The committee remains concerned that, without sufficient policy accommodation, economic growth might not be strong enough to generate sustained improvement in labor market conditions,” the Fed’s policy-setting panel said after a two-day meeting.

BALANCE SHEET ACTION

The Fed will fund the new Treasury purchases with an expansion of its $ 2.8 trillion balance sheet. Under the expiring “Operation Twist” program, the Fed bought an identical amount, but paid for them with proceeds from sales and redemptions of short-term debt.

Some policymakers view actions that expand the Fed’s balance sheet as economically more potent than actions that do not. However, Bernanke said the dose of stimulus would remain about the same, given that the central bank is still purchasing a combined $ 85 billion per month in longer-term securities.

“They see an anemic economy, and they’re doing all they can to get any economic progress,” said Alan Lancz, president of Alan B. Lancz & Associates in Toledo, Ohio.

The Fed’s decision initially gave a small lift to U.S. stock prices, but the major indexes closed mostly unchanged, while government bond prices fell. Oil prices rose and the dollar weakened against the euro.

Fed policymakers voted 11-1 to back the new plan. Jeffrey Lacker, president of the Richmond Federal Reserve Bank, dissented, as he has at every meeting this year, expressing opposition both to the bond buying and the new economic thresholds.

SWEATING A WEAK RECOVERY

The newly unveiled numerical policy guidelines offered the most specific suggestion yet that the Fed is willing to tolerate slightly higher inflation as it tries to juice up a moribund economy and spur stronger job growth.

A drop in the unemployment rate to 7.7 percent in November from 7.9 percent in October was driven by workers exiting the labor force, and therefore did not come close to satisfying the condition the Fed has set for trimming its stimulus.

In response to the financial crisis and recession, the Fed slashed overnight rates to zero almost exactly four years ago and bought some $ 2.4 trillion in mortgage and Treasury securities to keep long-term rates down.

Despite its unconventional and aggressive efforts, U.S. economic growth remains tepid. Gross domestic product grew at a 2.7 percent annual rate in the third quarter, but a Reuters poll published on Wednesday showed economists expect it to expand at just a 1.2 percent pace in the current quarter.

Businesses have hunkered down, fearful of a tightening of fiscal policy as politicians in Washington wrangle over ways to avoid a $ 600 billion mix of spending reductions and expiring tax cuts set to take hold at the start of 2013.

Bernanke has warned that running over this “fiscal cliff” would lead to a new recession. He told reporters the Fed could ramp up its bond buying “a bit,” but emphasized that monetary policy has limits and could not fully offset the impact.

NEW TACK ON RATES

He said the central bank would look at a range of indicators, not just the rates of unemployment and inflation, in determining when to finally push overnight borrowing costs higher, adding that the Fed was not on “auto pilot.”

“Reaching the thresholds will not immediately trigger a reduction in policy accommodation,” Bernanke said. “No single indicator provides a complete assessment of the state of the labor market.”

Bernanke said the new framework was consistent with the earlier calendar guidance, because officials do not expect the jobless rate to reach 6.5 percent until sometime in 2015.

Indeed, a fresh set of economic projections from the Fed put the rate in a 6 percent to 6.6 percent range in the fourth quarter of 2015. At the same time, the projections showed that at no point over that forecast horizon does the central bank see inflation topping its 2 percent target.

Officials held to their assessment that they could eventually push the unemployment rate down to a 5.2 percent to 6 percent range without sparking inflation, although Bernanke cautioned that policy would have to start tightening before it fell so low. In its statement, the Fed said its long-term asset purchase program would end well before any rate increase.

Fed policymakers see GDP expanding between 2.3 percent and 3.0 percent next year. That is down from the 2.5 percent to 3.0 percent they forecast in September, but is still a bit more optimistic than most private forecasters. The Reuters poll of economists found a median U.S. growth estimate of 2.1 percent for next year.

(Writing by Pedro Nicolaci da Costa; Editing by Andrea Ricci, Tim Ahmann, Leslie Adler and Andre Grenon)

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