prevention

Blood Diamonds Aren’t Gone, Says Global Watchdog

by The Huffington Post on December 5, 2011

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An International NGO at the forefront of investigating the illicit trade of blood diamonds has announced it will be leaving the United Nations-backed Kimberley Process . Global Witness said in a statement Monday that the group is pulling out of the conflict-free diamond certification program due to what they called its inability “to evolve and address the clear links between diamonds, violence and tyranny.” Launched January 2003 and named after a UN meeting in Kimberley, South Africa , the Kimberley Process program aims to trace the illicit trade of blood diamonds, with governments certifying that shipments of rough diamonds aren’t fueling wars or other violence. Nevertheless, Reuters reports the program can’t guarantee diamonds are conflict-free, pointing to several abuses across Africa where companies still mine for rough diamonds despite reported human rights abuses. In announcing their departure from the program, Global Witness Founding Director Charmian Gooch wrote on specific shortcomings: “The scheme has failed three tests: it failed to deal with the trade in conflict diamonds from Cote d’Ivoire, was unwilling to take serious action in the face of blatant breaches of the rules over a number of years by Venezuela and has proved unwilling to stop diamonds fueling corruption and violence in Zimbabwe.” Despite Human Rights Watch and Global Witness citing abuses in Zimbabwe’s mines , the Kimberley Process still gave the green light in November for two companies to export diamonds from the Marange diamond field in Zimbabwe, according to the BBC. Global Witness has long played a key role in monitoring conflict, corruption and natural resources. In 1997, the unknown NGO first discovered that diamonds were fueling war in West Africa. In late 1998, it launched a campaign that first drew the world’s attention to the blood diamond issue.

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McDonald’s Stockholders Reject Obesity Proposal, Defends Ronald

by on May 19, 2011

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OAK BROOK, Illinois (Debra Sherman) – McDonald’s Corp spurned calls to assess the impact of its food on childhood obesity, and said its trademark clown Ronald McDonald would be hawking Happy Meals to kids for years to come. “This is about choice and we believe in the democratic process,” Chief Executive Jim Skinner told a packed room at its shareholders’ meeting, to an enthusiastic wave of applause. “This is about the personal and individual right to choose.” Shareholders of the world’s largest fast-food chain resoundingly rejected a proposal that would have required it to issue a report outlining its role in the childhood obesity epidemic, saying customers were free to make their own dietary choices. “Ronald McDonald is an ambassador to McDonald’s and he is an ambassador for good. Ronald McDonald is going nowhere,” Skinner said firmly, prompting more cheers from shareholders. Among the dissenters at the meeting was Dr. Donald Zeigler, director of Prevention and Health Lifestyles at the American Medical Association, who asked when the burger chain will stop marketing to children using Ronald McDonald. Zeigler, who is also visiting assistant professor at Rush University Medical Center, was one of 550 healthcare professionals who had signed an open letter to McDonald’s pleading that it “stop making the next generation sick.” On Tuesday, a watchdog group placed ads in newspapers across the country calling for McDonald’s to stop marketing to children through the clown, toy giveaways and other tactics. Some 17 percent of children and adolescents are obese, according to the U.S. Centers for Disease Control and Prevention. Being overweight during childhood raises the risk of developing type 2 diabetes, high cholesterol, hypertension and a host of other diseases. McDonald’s has been a lightning rod for criticism for years over its marketing tactics and sales of Happy Meals for children that include toys as inducements. McDonald’s allows parents to swap milk or juice for soda in its Happy Meals. It also offers sliced apples with caramel sauce and chicken nuggets as alternatives to french fries and hamburgers. The restaurant chain has added healthier options to its menu, including salads and oatmeal, but critics argue there is still too much fat, salt and sugar in its meals. Even the oatmeal, one critic noted, contains about as much sugar as a Snickers candy bar. Skinner defended McDonald’s strategy, which has resulted in hefty sales and earnings for shareholders. McDonald’s shares have gained nearly 12 percent in the last four months and rallied to a record high of $82.63 on Thursday. But as experts point out, obese children often grow into obese adults, overburdening the entire healthcare system. Ironically, Miles White, chairman and chief executive of diversified healthcare company Abbott Laboratories, has been a director of the McDonald’s board since 2009. Abbott makes a broad range of drugs, including cholesterol-lowering statins, and medical devices, such as heart stents used on patients with clogged arteries. (Reporting by Debra Sherman, Lisa Baertlein and Jessica Wohl; Editing by Richard Chang) Copyright 2011 Thomson Reuters. Click for Restrictions .

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McDonald’s Stockholders Reject Obesity Proposal, Defends Ronald

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Japan Crisis Renews Call For Wider Distribution of Radiation Pills in U.S.

March 30, 2011

NEW YORK — Three weeks ago, it was a chemical compound familiar mostly to pharmacists and radiation experts. Now, in light of the ongoing nuclear crisis at the Fukushima Daiichi plant, potassium iodide has become a highly desired commodity in both Japan and the United States for its protection against radiation-induced thyroid cancer, especially in young children. But in the years leading up to the calamity at Fukushima, the U.S. Nuclear Regulatory Commission and top officials in the Bush and Obama administrations have resisted efforts to expand distribution of potassium iodide to a wider array of people living near nuclear power plants in the United States. Their principal argument has been that limiting access to food, water and milk potentially tainted by radioactive elements is more effective than supplying more radiation pills to the public. Congress in 2002 passed a counterterrorism bill that required state and local governments to stock supplies of potassium iodide for people living within a 20-mile radius of nuclear power plants, an expansion of an optional 10-mile zone for the radiation pills that was previously in place. The law included a provision, however, that allowed the president to waive the new rules if alternative, more effective measures were identified. In a January 2008 memo , a science adviser to President George W. Bush wrote that it would be more effective to tell people outside of the 10-mile zone to evacuate or avoid eating contaminated food from the area if there were a radiological release. The memo from John M. Marburger, the director of Bush’s Office of Science and Technology Policy, wrote that the new 20-mile mandate “places an unnecessary burden on state and local emergency preparedness coordinators already struggling with the establishment and maintenance of programs within the 10-mile (emergency zone).” He added, “A nuclear power plant accident that creates public health risks beyond the 10-mile range would be a highly unusual catastrophic event.” But as concerns widen over elevated radiation levels found in food and water supplies 50 to 100 miles away from the stricken Fukushima plant in Japan, there is a growing scrutiny of U.S. emergency response standards in the event of a nuclear disaster at home. “When radiation comes out of a plant like this, you have no idea how far it’s going to go, how heavily it’s going impact one area versus another,” said Jeffrey Patterson, a radiation exposure expert at the University of Wisconsin School of Medicine and Public Health who serves on the board of the advocacy group Physicians for Social Responsibility. “It has to do with wind patterns, it has to do with rainstorms. All of those things affect where the iodine goes.” The 10-mile emergency zone in the United States applies both to distribution of radiation pills and mandatory evacuation around a nuclear power plant, which is significantly less than the Obama administration’s call last week for evacuation of U.S. citizens within 50 miles of the Fukushima Daiichi facility. The disaster in Japan has prompted renewed calls to expand distribution of potassium iodide to a wider area, particularly from Rep. Edward Markey (D-Mass.), who authored the potassium iodide provision in the 2002 counterterrorism bill. Markey wrote a letter to the Obama administration in the week after the tsunami urging that the 20-mile zone be adopted. “We should not wait for a catastrophic accident at or a terrorist attack on a nuclear reactor in this country to occur to implement this common-sense emergency preparedness measure,” Markey wrote. The letter followed a similar December 2009 letter to Obama. The administration rejected Markey’s argument last summer, claiming that the previous limits were adequate. Potassium iodide is in no way a cure for radiation emitted from a nuclear disaster, but if taken before or immediately after exposure it can be effective in reducing the risk of thyroid cancer. Taking the pills effectively fills the thyroid gland with enough iodine to prevent the gland from absorbing radioactive iodine, a harmful isotope emitted from a nuclear reactor. Infants and young children are particularly susceptible to thyroid injury. The pills can also be harmful to young children, however, if taken in greater quantities than prescribed. Adults over 40 have the least risk of developing thyroid cancer from radiation, according to the Centers for Disease Control and Prevention , and also are more prone to an allergic reaction. The pills do not shield the body from other complications due to radioactive exposure, or from any other radioactive elements aside from iodine. People who are allergic to iodine or have a preexisting thyroid disease are advised to consult doctors before taking potassium iodide, according to the CDC. In recent weeks there has been a run on potassium iodide at drug stores in the United States, as some have panicked that radiation from the reactor in Japan would reach the West Coast. Local and state public health agencies in California have warned against taking potassium iodide in response to the Japanese reactor crisis, because of the minuscule chance of radiation traveling thousands of miles across the Pacific Ocean. The debate in the United States involves those living in the immediate vicinity of a reactor. The Nuclear Regulatory Commission and the Department of Health and Human Services have provided potassium iodide to state and local government agencies that request the pills within the 10-mile zones around nuclear plants. Local government agencies then either choose to distribute the potassium iodide or stockpile it in the event of an emergency. At the time the 20-mile rules were proposed, the Nuclear Regulatory Commission wrote in formal comments that expanding potassium iodide distribution was “unnecessary.” “We have concluded that other, more effective, protective measures are in place to protect the thyroid gland in the event of a release of radioactive iodine,” the commission wrote in a letter to the Department of Health and Human Services, which was tasked with enforcing the rule. The alternatives included preventing people in the area from eating or drinking contaminated food, milk and water, and protecting livestock. Other state and local government bodies expressed concerns about requirements to expand stockpiles of potassium iodide. Although the NRC pays for the potassium iodide supplies, state and local governments must pay to administer the pills to the public. A spokeswoman for the Nuclear Regulatory Commission wrote in an email, “As part of the NRC’s 30-, 60- and 90-day report on ‘lessons learned’ from the Japanese nuclear emergency, all aspects of nuclear power plant safety and security regulations will be reviewed.” A spokesman for Obama’s Office of Science and Technology Policy offered a similar response, saying that distribution of potassium iodide will be among many policies under review.

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Vending Machines: The Latest Recession Victim

January 31, 2011

Vending machine thefts are rocketing, thanks to hard times. Criminal gangs in Georgia, South Carolina, Mississippi and New York are targeting vending machines according to the Wall Street Journal. Although vending machine owners factor in the assumption that 3 percent of sales will disappear thanks to sticky-fingered employees and petty thefts, the problem is getting worse, according to the WSJ , with criminals using welding torches and bolt cutters to break into machines. “My sense is that theft is on the rise as there are so many people in desperate times,” Mark Manney, chief executive of Loss Prevention Results Inc., told the WSJ . Vending machine operators told the WSJ that the trend was exacerbated by several instructional videos on YouTube offering vending machine-looting expertise. The snack attacks come as vending machine sales fall. According to figures from trade magazine Automatic Merchandiser , U.S. sales fell 10 percent, from $22 billion in 2008, to almost $20 billion in 2009. With razor thin profit margins of 1 percent, every theft makes a difference, and with thefts usually amounting to just a few dollars, cops stay away. The WSJ reports on vending machine owners who are responding with wireless security systems that can send mid-heist alerts. One such owner, Marcus Whitener, retrofitted 4,000 of his vending machines with wireless devices: When a vending door is opened at unauthorized times or power is cut, Mr. Whitener receives a text message and email. Within nine months of installing the systems, Mr. Whitener said, seven of his 25 route drivers quit or were fired. Five quit after he started asking questions about cash shortages.

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David Katz, M.D.: Walmart’s Health Changes: Fact Or Fiction?

January 22, 2011

At a press conference this week featuring none other than First Lady Michelle Obama, Walmart made pledges that should, in principle, put more nutritious food within easier reach, literally and figuratively. Literally, because the nation’s largest grocer promised to reduce sugar and sodium in its own product line, and eliminate added trans fats over the next five years. They also plan to develop a logo to signify foods that meet their internal standard for better nutrition. These promises sound good, and along with my public health colleagues, I commend Walmart for making them, and in anticipation of Walmart keeping them. But I must append some precautionary caveats. Perhaps ironically, even as Walmart was promising both to provide more nutritious foods, and tell us which ones they are, the national non-profit, Prevention Institute, issued a report indicating that entities selling us food are not reliable judges of nutritional quality. The report, based on an examination of various front-of-pack claims indicating “more nutritious” children’s foods, found that nearly 85 percent of the products with specific shout-outs about their nutritional virtues were unhealthy by the evaluators’ objective standards. I can validate this worry with a personal view from altitude. NuVal scores for overall nutritional quality have been generated for over 90,000 food products thus far. These scores require a database of ingredient lists, nutrition facts and scanned images of packaging for every product. In fact, to our knowledge, this is by far the largest and most detailed nutrient database on the planet. It provides a disquieting view of how marketing claims and nutritional reality part company . The NuVal database includes examples of sugar-reduced kids’ cereals that are less nutritious than the original, because of added sodium, reduced fiber and other changes. The average score for regular peanut butter is a respectable 20; the average score for seemingly more nutritious fat-reduced peanut butter is a far-less-respectable 7, because of copious additions of sugar and salt in place of the removed fat. In fact, the consistency with which front-of-pack nutrient claims and an objective measure of overall nutrition go in opposite directions is so compelling that we are currently pursuing a formal analysis. Will Walmart offer us truly more nutritious products, or products tweaked to allow for claims of better nutrition belied by an objective measure of overall nutritional quality? Time will tell. As for putting nutritious foods figuratively within easier reach, Walmart also pledged to reduce prices of healthful foods — produce in particular. Here, too, the commitment sounds good. But here, too, some caveats attach. First, with the possible exception of the produce aisle, more nutritious food does not necessarily cost more right now, despite the urban legend that it does. In a research paper currently in press, my colleagues and I report what happened when we sent a volunteer grocery shopping with nutrition standards ( freely available to you , by the way) and instructions to buy equal numbers of foods from a variety of categories meeting, and failing the standards. We compared price, and found no difference. Why the urban legend in the first place? Because health conscious shoppers are willing to pay a premium for more nutritious foods, so there is an incentive to make foods that call out their nutritional virtues on the package, whether or not they are in fact nutritious overall, and charge extra for them. That practice prevails. But by and large, such foods are not more nutritious — just more expensive! Often, a less expensive, more humbly packaged alternative offers better nutrition as well. Walmart may simply be engaging in good corporate citizenship (I know some of the good people in high places there, and this is by no means implausible); they may be propping up their argument for real estate in New York City ; or they may be making some promises they will have a hard time keeping. But come what may, we all know that the business of business is business, and no publicly traded company will go very far in a direction that makes share holders unhappy. What Walmart does must ultimately be good for their bottom line, whether or not it’s good for yours. Logically, there is only so much a company that sells food can benefit from lowering the price of food. If we want real action in the area of making more nutritious foods more affordable, we need it from those directly involved in paying the health care costs that relate in no small measure to the bad food choices that currently prevail. The development and course of obesity, diabetes and cardiovascular disease are powerfully and directly associated with food choices . For cancer, osteoporosis, arthritis and a number of other conditions, the causal chains are a bit longer and more twisted, but diet is still quite clearly among the key links. Thus, policies that meaningfully shift food selection and diet pattern in a healthful direction with financial incentives could also meaningfully reduce the population burden of these conditions, which in turn could slash health care costs. The SNAP program would be a great place to prove the principle (my lab is working on that!). A little money spent to discount objectively more nutritious foods could generate vastly larger savings related to chronic disease care costs. Large employers, private insurers and the federal government could all win big. And so could we. But only when the promise of truly better food, truly within easier reach of all, is truly kept. Dr. David L. Katz www.davidkatzmd.com www.turnthetidefoundation.org

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Big Retailer To Offer $99 Health Care Plan

January 12, 2011

NEW YORK (CNNMoney) — Beginning this month, Sam’s Club shoppers stocking up on milk, detergent and toilet paper, can now also throw a basic health service package into their shopping cart. The package, which will cost $99, is called “The Prevention Plan” and is offered by U.S. Preventive Medicine.

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Woman Jumps To Her Death At Trump Place

December 20, 2010

A 27-year-old analyst for Citigroup and local philanthropist shocked friends and family as she jumped to her death from Trump Place on Saturday. Not much is known yet as to why Jessica Fashano would decide to take her own life. By all accounts she was not only a rising business star but also a deeply generous and charitable person. According to the New York Times , “she seemed to care more about others than about herself.” She spearheaded fund-raisers for the Acumen Fund, which makes small-business loans to people in developing countries. And just in the past month, friends said, she helped coordinate a fund-raiser at a West Village boutique for Harboring Hearts Housing, a charity that provides lodging at modest prices for cardiac patients. Fashano was seen on videotape entering a West Side apartment building she did not belong to, 16 blocks north of where she lived. In the elevator she asked a resident how to get to the roof, and at 8:13 a.m. police found her body in a nearby courtyard. Why exactly Fashano chose this building, and that she left no suicide note, are among the many questions surrounding her death. Although the police said she was undergoing treatment for depression, friends and associates said she was always in high spirits. “It’s like something just changed overnight,” said Ms. Javian, who said she spoke to Ms. Fashano daily and was supposed to have had brunch with her on Saturday morning. “Something just snapped, and we don’t know.” Need help? In the U.S., call 1-800-273-8255 National Suicide Prevention Lifeline

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SHAPE Appoints Executive Director

December 20, 2010

HOUSTON, TX–(Marketwire – December 20, 2010) – SHAPE, The Society for Heart Attack Prevention and Eradication ( http://www.shapesociety.org ), a nonprofit organization that promotes early detection and preventive intervention to reduce heart attack risk, is pleased to announce the appointment of Jay Donnella as executive director. In his new role, Donnella is responsible for spearheading the implementation of SHAPE’s strategic plans and raising awareness that heart attack can be eradicated if new preventive strategies are adopted.

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FCIC Delays Report Despite Republican Opposition, Citing ‘Very Powerful Interests’ Seeking To Undermine Investigations

November 18, 2010

The bipartisan panel created to investigate the roots of the financial crisis voted Wednesday to delay the Dec. 15 publication of their report despite Republican opposition, foreshadowing disagreements that are sure to arise when the commission attempts to reach a consensus on the causes of the worst financial crisis since the Great Depression. The Financial Crisis Inquiry Commission’s 6-to-3 vote came after the panel’s four Republicans argued privately against the decision to ignore the statutory deadline set by Congress. One of the Republicans, former Congressional Budget Office Director Douglas Holtz-Eakin, was unable to participate in the vote, though he made his dissent known. The report will now be released in January. The move comes on the heels of revelations that the nation’s biggest mortgage companies employed possibly-fraudulent tactics in trying to foreclose on distressed homeowners. The recent disclosures by the likes of Bank of America, JPMorgan Chase and Ally Financial that they used flawed documentation practices sparked inquiries by all 50 state attorneys general, as well as federal prosecutors and federal regulators, among others. Those investigations are ongoing. The crisis commission is also looking into the matter, said Phil Angelides, the panel’s Democratic chairman. The Republicans on the panel are resisting further inquiries, according to people familiar with the matter. Angelides said in an interview that “there are very powerful interests” seeking to undermine the panel’s investigation. “People who have trillions of dollars at stake who have been watching our efforts closely,” Angelides said. “There have been efforts throughout the year to undermine me and my fellow commissioners.” Among other things, Angelides’ panel is probing the documentation practices that federal watchdogs say may be emblematic of the entire mortgage securitization chain, in which lenders may have used bogus documents when originating mortgages and passed them through to other entities before they were sold to investors, ignoring basic due diligence along the way. The discovery of the use of “robo-signers” — employees whose sole job was to rubber-stamp documents without actually reading them or verifying their contents — “may have concealed much deeper problems in the mortgage market,” the Congressional Oversight Panel reported Tuesday. Large lenders and Wall Street banks may be on the hook for hundreds of billions of dollars in unexpected losses, threatening to undermine “the very financial stability that the Troubled Asset Relief Program was designed to protect,” the COP report noted. The information the crisis commission has gathered from its numerous public hearings has added fuel to that fire. During an April hearing, the panel heard from Richard Bowen, former chief underwriter for Citigroup’s consumer-lending unit, who said he discovered in mid-2006 that more than 60 percent of mortgages the bank bought from other firms and sold to investors were “defective.” Investors were not informed, however. In September, the former president of the nation’s leading home-loan due-diligence firm testified that as many as 28 percent of mortgages given to borrowers with poor credit that the firm examined for Wall Street banks failed to meet basic underwriting standards, and that nearly half of them were likely sold to investors anyway. Keith Johnson, formerly of Clayton Holdings, said he was unaware of any disclosure to unwitting investors by the banks. Together, the testimony and accompanying data could bolster pension funds and other investors in their pursuit to force Wall Street banks to buy back the bogus mortgages they peddled. Investors are trying to use the rights prescribed in the agreements from their initial purchases of the mortgage-linked securities. Analysts from Compass Point Research and Trading LLC pegged potential losses for 11 global banks to reach $179.2 billion, the Washington-based firm said in an Aug. 17 report. The crisis panel, though, was expected to be wrapping up its report on the crisis. The law that created the commission says: “On December 15, 2010, the commission shall submit to the President and to the Congress a report containing the findings and conclusions of the commission on the causes of the current financial and economic crisis in the United States.” In a statement, the four Republicans on the panel — Holtz-Eakin, Vice Chairman Bill Thomas, Keith Hennessey and Peter Wallison — said that the commission is “statutorily required to deliver the report on December 15.” They added that the panel “has had over a year to complete the report” and that the delay was due to a need to “accommodate the publication of a book-length document.” The FCIC hopes to publish a book on its findings, similar to the national best-seller that came from the work of the 9/11 Commission. The crisis panel recently switched publishers. The law allows the panel an additional 60 days “for the purpose of concluding the activities of the commission … and disseminating the final report.” It’s under that additional 60-day authority that Angelides and his fellow Democrats are using to justify their delay by up to six weeks. The panel’s authority formally ends Feb. 13. To date, the commission has interviewed more than 700 people, examined hundreds of thousands of documents and held 19 days of public hearings, Angelides wrote in a Wednesday letter to President Barack Obama. In an interview, Angelides said his team of investigators continue to pursue leads in their “ongoing investigation.” He added that they’re also interviewing new witnesses, in addition to circling back to old ones, indicating that the panel continues to push its investigation further. Congress tasked the panel to deliver its findings on 22 distinct areas, ranging from monetary policy to accounting rules and international capital flows. They also include the role of “fraud and abuse in the financial sector, including fraud and abuse towards consumers in the mortgage sector”; “lending practices and securitization”; and “the quality of due diligence undertaken by financial institutions.” All three of those areas would seem to include the current mortgage and foreclosure documentation issues roiling big banks and the financial sector. However, there may be complications in trying to advance its investigation. Because the law says that the commission’s findings must be sent to the President by Dec. 15, there are open questions regarding the validity of further investigative actions beyond that date, including issuing subpoenas, people familiar with the crisis panel’s efforts said. For example, a firm may have grounds to resist the subpoena, these people said. Hennessey wrote that a vote to delay the report “would violate the law, or at a minimum would be inconsistent with the law,” according to a post on his blog. “The FCIC is a creation of a law, and we must be governed by that law whether we commissioners like it or not,” he wrote. The crisis panel isn’t the first to unilaterally delay the release of its congressionally-mandated report. The Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism blew past its deadline, as did the National Bipartisan Commission on the Future of Medicare and the Commission on Affordable Housing and Health Care Facility Needs in the 21st Century. Those panels, however, didn’t have subpoena authority. And their reports were largely advisory. The FCIC can make criminal referrals to the Department of Justice. Like the FCIC, the 9/11 Commission also had substantial powers, and it, too, extended its own deadline. However, the 9/11 panel got its extension from an act of Congress. Angelides said the extra time will be critical for the panel’s investigation and subsequent report. In a statement, the spokesman for Senate Banking Committee Chairman Christopher Dodd said the Connecticut Democrat supports the panel’s investigation, and was not opposed to the report’s delay. Dodd indicated that a “brief delay to allow the commission to finalize and prepare a more thorough report was not unreasonable,” spokesman Sean Oblack wrote in an email.

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SHAPE Appoints JoAnne Zawitoski Chair of Board of Directors

November 10, 2010

HOUSTON, TX–(Marketwire – November 10, 2010) – SHAPE, The Society for Heart Attack Prevention and Eradication ( http://www.shapesociety.org ), a nonprofit organization that promotes the early detection and treatment of heart attack risk in apparently healthy people, today announced the appointment of JoAnne Zawitoski as chair of its Board of Directors. Founding SHAPE Board Chairman Morteza Naghavi, M.D. will remain active as executive chairman of the SHAPE Task Force.

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Sheila Shayon: Digital Democracy: Scytl, MySociety Secure Funding

July 14, 2010

We may never again have to suffer “pregnant chads,” “swinging chads” and other questionable voting protocols in an election thanks to the likes of Scytl, which calls itself a “worldwide leader in the development of secure solutions for electoral modernization.” Scytl, which started in 1994 from a PhD thesis on electronic voting before creating a company to develop online voting technology, just landed $9.2 million investment funding. The Barcelona-based company has run the gauntlet of 13 national tests of electronic public voting, including the U.S., France, Norway, Bosnia-Herzegovina and Australia. Scytl supplies the tools for two types of electronic voting: remote e-voting, casting of votes through any device (PC, mobile phone, PDA, etc.) with an Internet connection; and poll-site e-voting, which entails casting of votes from touch-screen electronic voting terminals located in polling stations. According to Scytl, the main advantages of electronic voting include: – Speed and accuracy in the vote counting process, – Accessibility for blind and visually impaired voters, – Flexibility in the design and modification of the ballots, – Prevention of involuntary voting errors (e.g., “over-voting” and “under-voting” errors), – Ease-of-use for voters, – Support of multiple languages, etc. – Furthermore, in the case of Internet voting, there is the additional advantage of voters’ mobility and convenience which generally leads to higher turnout rates. Further details about security and voter privacy are outlined on the Scytl website. In a related vein, eBay founder Pierre Omidyar’s Omidyar Network recently gave digital startup MySociety $575,000. MySociety has dual missions: a non-profit arm which builds websites that promote civic and community goals; and to teach the public and voluntary sectors, through demonstration, how to use the internet most efficiently to improve lives. Perhaps e-voting and digital tools that ensure accuracy and fair representation are finally becoming sustainable and investable businesses. Originally published on Brand Channel .

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Danny Schechter: Homeowners Mobilizing to Stop Foreclosures

June 16, 2010

MEMORIES AND MISERY IN CNN LAND WHILE HOMEOWNERS SEEK MORTGAGE JUSTICE AND FORECLOSURES MOUNT Atlanta: Somehow, I can’t escape CNN. Last Saturday I joined Ted Turner, Wolf Blitzer and more than 300 current and former CNN employees at a celebration of the network’s 30th anniversary at the National Press Club in Washington. I was there as one of the “CNN Originals,” the many staffers who helped originate what was mocked as the Chicken Noodle Network in Atlanta back in June l980. There was pride and sense of achievement in the room by those who pioneered 24 Hour Cable News on small budgets but with lots of heart, coffee and sleepless nights. Being there was often thrilling and part of my personal learning curve on how big media works, a story I tell in my book The More You Watch The Less You Know . It was an unforgettable time, and, even though, I soon moved on to ABC News, I was pleased, even honored, to be part of it. As fate would have it, a day after that CNN celebration, I was back in Atlanta at CNN Center, actually, across the street, at the Georgia World Congress Center where another news-making network was holding forth. Drawing tens of thousands of people trying to save their homes, the Neighborhood Assistance Corporation of America (NACA) was holding its 19th SAVE THE DREAM event, this time in cooperation with the City of Atlanta. Fox in Atlanta called it “hugely successful.” CBS reported what I saw up close and personal: More than 25,000 people have asked for help. NACA said so far it’s their biggest event. They said people were coming in from all over the country. Judy Richmond from Lithonia has waited more than 24 hours. She said, “We knew there would be a lot of people, but we thought the process would be a lot smoother.” She said she was willing to wait for help navigating the mortgage world. Bruce Marks, CEO of NACA, said, “When you have the opportunity to save thousands of dollars a month people are willing to do that.” He said they have a thousand volunteers working to keep things moving. He said there are also thousands working the phones. In the giant hall designed for trade shows, homeowners were getting up every few minutes to report on how much they had had their payments cut. With every announcement, those who were still waiting broke into cheers. For many, those cuts represent a chance at economic survival in hard times. To them, these are real “solutions” for very stressed lives. I found it bizarre that outside the Center, an outfit called Billboards for America was paying for a huge sign proclaiming ” GOD IS NOT A SOCIALIST.” Inside, the Federation of Retail Merchants was also holding a Loss Prevention Summit in response to a spike in shoplifting blamed on the lousy economy. Unfortunately, there had been no loss prevention seminars for these homeowners who were talked into taking mortgages they couldn’t afford. They were there in droves to receive free counseling and seek out mortgage modification in meetings with representatives of lenders and banks. The Bank of America, which just settled a major mortgage fraud case, was out in force reducing mortgage payments for borrowers who qualified. Another bank, JP Morgan Chase, which has recently been targeted with protests by NACA members was not taking part. Instead, they were cynically competing with NACA by running their own home ownership event at a nearby hotel to demonstrate how responsible they are. They sent a truck with a big sign promoting their offering to drive around the Congress Center and taunt NACA which found it amusing since their event was minuscule in comparison. NACA’s issue is getting some national attention too, from of all quarters, The FBI, which is reportedly planning a national crackdown on mortgage fraud this week. The Financial Times reported: Hundreds of people are expected to be arrested in the sweep, which will start as early as next week, The FT said, citing two people with knowledge of the operation. An F.B.I. spokesman declined to comment to the newspaper. Charges are expected to be leveled over offenses ranging from pushing borrowers to lie about their income on mortgage applications to providing homeowners with false information about foreclosure rescue programs, the newspaper said. The British newspaper is ahead of the US press in stating that “it was mortgage fraud that led to the expansion of the housing bubble and eventually accounted for its catastrophic burst, as loans were handed out to borrowers with unsubstantiated incomes and low credit ratings.” These homeowners wait patiently for help from a not for profit group, not their own government. The basement of the Georgia conference center is packed with victims of the financial crisis while the people who caused it operate freely from their office towers and penthouses. They are the mortgage industry backed by their friends in the big banks who lent the money, and the Wall Street firms that securitized and resold the mortgages at inflated values with high ratings bought from rating agencies. (The “financial reformers” in Congress have just dropped new rules for these agencies from the “reform bill.”) Also to blame are the insurance firms that protected the lenders against defaults in an enterprise they knew was fraudulent. Unfortunately the FBI is not going after this triad but only the lowest level violators. There should be a RICO prosecution of the big guns in this avaricious cartel, not just the small fry and street soldiers. If there ever was an organized criminal enterprise this is it. At least there is this force fighting for justice. Arguably it is bigger than the Tea Party and its populism is just as angry even as its been overlooked on the left. Can this anger be organized politically? There are those in NACA who are thinking about mobilizing their many members to press politicians to act and play a more political role. If they go in that direction they will be confronting the corporate Goliaths who are very angry themselves about all this anger and quite condescending. Listen to GE’s CEO Jeffrey R. Immelt: “People need to tone down the rhetoric around financial services and stop the populism and be adults.” Excuse me, Mr. GE: The people here are adults with a right to be pissed off. This is part of the story I tell in my film PLUNDER The Crime of Our Time . Unfortunately, it’s not just documenting a distant past but a still ongoing tragedy. All you have to do is look in the faces and listen to the stories of the homeowners still experiencing heartless foreclosures and you realize that the Administration, judicial, corporate and media response has been pitiful. Kudos to NACA for leading the fight and offering practical services, and to those media outlets who are finally waking up and telling the story even though most, including CNN, don’t yet see it as a crime story. Perhaps if there were A-List celebrities there, it might have been carried as a telethon. News Dissector Danny Schechter directed the DVD, Plunder The Crime of Our Time and wrote a companion book (Plunderthecrimeofourtime.com) Comments to dissector@mediachannel.org

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Youth Hockey Injuries Tripled in Body-Checking Study That May Spur Debate

June 8, 2010

By Nicole Ostrow June 8 (Bloomberg) — Eleven-and 12-year-old ice hockey players showed triple the risk of injuries in games that allow body checking, according to a Canadian study that may “add some heat to the temperature of this topic,” said a director with the U.S. governing body for hockey. Body checking occurs in a hockey game when one player slams into another to knock the puck loose from possession. Youth teams in the Canadian province of Alberta, where the practice is allowed starting at age 11, showed triple the risk of severe injuries and concussions compared with those in Quebec province, where it isn’t permitted in players younger than 13, according to the study. Today’s report , published in the Journal of the American Medical Association, may add to the discussion of body checking already planned at the annual meeting of USA Hockey that begins June 10, said Kevin McLaughlin, the group’s senior director for hockey development. A subcommittee of the sports association is considering raising the age to 13 for the introduction of body checking to allow younger players to develop other skills first — not because of injuries, he said. “I’m interested in every kid having a great experience in youth hockey,” McLaughlin said today in a telephone interview. “We don’t want injuries to happen at any age. It is a contact sport. Injuries still do occur even when you don’t have body checking.” Hockey Basics By developing other game skills initially, young players can become proficient at hockey basics before they’re taught how to body check, McLaughlin said. He said he wouldn’t predict how the organization will react to today’s study. Authors of the research said it is one of the first studies to compare the risk of playing in a youth ice hockey league that allows body checking with one that doesn’t. If the practice wasn’t permitted, more than 1,000 injuries and 400 concussions may be prevented among about 8,800 hockey players ages 11 and 12 in one season in Alberta, said lead study author Carolyn Emery . “The two leagues provided an excellent opportunity to study the public health impact of concussion and injury associated with body checking,” said Emery, an associate professor of sports injury prevention at the University of Calgary, in a statement. “The facts speak for themselves.” 900,000 Youth Players About 900,000 children and teenagers play ice hockey through Hockey Canada and USA Hockey, authors of the study wrote. Many leagues in the U.S. introduce body checking at ages 11 and 12. In Canada, body checking is allowed in some leagues for players ages 11 and 12, with the exception of Quebec, which doesn’t permit the practice until ages 13 and 14, according to the authors. In the U.S., the American Academy of Pediatrics recommends that body checking not be allowed in youth hockey until the age of 16. The practice has been associated in previous studies with 45 percent to 86 percent of youth hockey injuries, the authors wrote. McLaughlin said youth hockey players learn a progression of skills that lead up to body checking. About six years ago, USA Hockey offered a nonchecking category for its leagues but few players registered. USA Hockey represents about 99 percent of all youth players in the U.S., McLaughlin said. Fast, Dynamic “We understand the risk related to body checking in the sport,” Paul Carson, director of hockey development for Hockey Canada in Calgary, said today in a telephone interview. “It is the nature of the sport, it’s fast, it’s dynamic.” Hockey Canada represents all youth players who play during the winter months. Hockey Canada offers training programs for coaches on safety for youth players, he said, and there are some leagues in Canada where body checking isn’t allowed. Hockey Canada will be reviewing the study findings, Carson said. In the U.S., about 135,000 children 5 to 18 years old are treated in U.S. hospital emergency rooms every year for sports- related traumatic brain injury, including concussions, according to a 2007 study by the U.S. Centers for Disease Control and Prevention . Researchers in the study followed 74 teams in the Canadian province of Alberta with 1,108 players, and 76 Quebec teams with 1,046 players for a hockey season to compare the injury rates. Over the season there were 209 game-related injuries and 73 concussions in Alberta compared with 70 game-related injuries and 20 concussions in Quebec, the researchers found. Identifying the Cause Most of the injuries in Alberta were the result of body checking, the authors wrote. In Quebec, the majority of the injuries were from incidental game contact, Emery said. The study also showed that overall injuries from intentional contact were higher in Alberta than in Quebec, suggesting that kids who are allowed to body check play hockey more aggressively, she said. Emery said a new study is under way comparing players ages 13 and 14 in Alberta with those in Quebec, and that may shed further light on injuries. “This study in conjunction with the next will have significant implications in the reconsiderations of the age at which body checking is introduced,” Emery said in a June 4 telephone interview. Today’s study was funded in part by the Canadian Institutes of Health Research and the Max Bell Foundation. To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net .

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Illegal Tobacco Selling to Minors in U.S. Climbs After Decline

June 4, 2010

By Molly Peterson June 4 (Bloomberg) — The percentage of retailers who made illegal sales of tobacco to young people in the U.S. rose, for the first time in at least 13 years, amid state enforcement cutbacks, a federal study found. About 10.9 percent of retailers inspected by state officials sold tobacco to customers under the age of 18 in the year ended Sept. 30, up from 9.9 percent a year earlier, according to a report released today by the Substance Abuse and Mental Health Services Administration . State budget cuts and fewer inspections contributed to the increase, the report said. The Food and Drug Administration is implementing a law barring companies led by Altria Group Inc. and Reynolds American Inc. from marketing tobacco to young people. The law, signed by President Barack Obama last June, also bans retail sales of tobacco to minors. FDA rules, due to take effect June 22, will let the agency enter contracts with states to enforce the curbs. “Today’s report shows that we need to continue to be vigilant in our efforts, including providing adequate attention and resources, to continue the hard-earned progress we have made over the past 13 years in reducing youth access to tobacco products,” SAMHSA Administrator Pamela Hyde said today in a statement. The public-health agency is part of the U.S. Department of Health and Human Services. On the basis of random compliance checks in each state, the rate of violations by retailers was found to be highest in Oregon, at 18.8 percent, and lowest in North Dakota, at 1.6 percent, according to the report. The national average was computed by weighting state findings to take population into account. The nationwide increase was the first to be found since the surveys started in 1997, when the agency started requiring states to bar tobacco sales to minors as a condition of receiving federal funds for substance-abuse prevention and treatment. The U.S. figure had declined in each annual survey after the first one, until last year. In 1997, the rate was 40.1 percent. Smoking is the nation’s biggest cause of preventable death, killing about 443,000 people a year, according to a 2008 report from the U.S. Centers for Disease Control and Prevention , based in Atlanta. To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

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Teenage Boys’ Fear of Getting Girls Pregnant Drops, CDC Says

June 2, 2010

By Ellen Gibson June 2 (Bloomberg) — Teenage boys are becoming less worried about getting a girl pregnant, with a quarter saying they would be pleased if it happened. A higher percentage of boys ages 15 to 19 also agreed that it’s acceptable for unmarried girls to have babies, according to a report released today by the Centers for Disease Control and Prevention that compared teens’ attitudes toward sex in 2006 to 2008 to those in a survey six years earlier. The report also showed an increase in the number of teens using the unreliable “ rhythm method ,” which leads a quarter of users to get pregnant within a year. The boys’ attitudes and the increased use of risky ways to avoid pregnancies contrasts with the trend observed between 1988 and 2002, when the researchers saw a steady decline in so-called “sexual risk behaviors,” the report said. Overall, the number of teens having sex and their use of contraceptives was unchanged from the earlier survey, according to the data. “Anytime you see a loss of momentum compared to the straightforward improvements of the past, you think that efforts to motivate teens to use contraception need to be redoubled,” said Joyce Abma , a social scientist at the CDC’s National Center for Health Statistics and the paper’s lead author. “On the other hand, there could be a point at which you’ve reached a lot of teens and the ones left are the hardest to reach.” National Survey The data in the report, known as the National Survey of Family Growth, was collected through in-person interviews with 2,767 teenagers ages 15 to 19. The survey is taken every six to seven years. Among never-married females, 42 percent reported having sex at least once. The proportion of males in that age group who have had sex was 43 percent. Among those who abstained, the most common reason they cited was that sex was “against religion or morals.” The number of boys who chose “don’t want to get female pregnant” as the reason for avoiding sex fell by half to 12 percent from the last survey. Childbearing outside of marriage was acceptable to 64 percent of males in the current survey, up 14 percent from 2002, the Atlanta-based agency said. Those attitudes show boys are less worried about an unwanted pregnancy, Abma said in a telephone interview. The current study showed a handful of improvements in teens’ sex behavior since 2002. The use of more than one form of birth control — in most cases, the condom and the pill — increased 73 percent. Females also experimented with a wider variety of contraceptive methods: 11 percent said they’d tried patches such as Johnson & Johnson ’s Ortho Evra, while 7 percent had used vaginal rings such as Merck & Co. ’s NuvaRing. In addition, the percentage of unmarried males who reported using a condom during their first sexual experience rose to 82 percent in the latest study from 71 percent in 2002. The higher use may have more to do with increased awareness of sexually- transmitted diseases than pregnancy prevention, the CDC said. To contact the reporters on this story: Ellen Gibson in New York at egibson9@bloomberg.net ;

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Obama Will Use Russia Arms Accord as Leverage to Curb Iran Nuclear Program

April 7, 2010

By Julianna Goldman April 8 (Bloomberg) — President Barack Obama signs a nuclear-arms treaty with Russia today that he will try to use to build international support for increasing pressure on Iran and preventing terrorists from getting atomic material. Obama and Russian President Dmitry Medvedev will gather at noon for a ceremony in Prague to cap the deal. U.S. officials have said the new Strategic Arms Reduction Treaty, which trims the U.S. and Russian arsenals by about 30 percent, bolsters the American commitment to Non-Proliferation Treaty obligations and will encourage other countries to demand compliance. The accord “shows the world, particularly states like Iran and North Korea, that one of our top priorities is to strengthen the global nonproliferation regime and keep nuclear materials out of the wrong hands,” Secretary of State Hillary Clinton said March 26, when the deal was announced. Iran has rebuffed calls to stop what the U.S. and its allies say is the Islamic republic’s pursuit of a nuclear- weapons capability and to engage in negotiations. Obama, who said March 30 he would push for tougher United Nations Security Council sanctions on Iran “within weeks,” needs broad international enforcement of potential new measures such as authority to seize Iranian cargoes and cut off credit. “If the U.S. and Russia did not get moving together on reducing nuclear weapons, nobody else in the world is going to,” former U.S. Defense Secretary William Perry said in an interview. “The whole issue of trying to contain nuclear proliferation and trying to deal with rogue states would have a huge setback.” It was in Prague a year ago where Obama articulated a vision of a nuclear-free world that won him a Nobel Peace Prize. Obama’s Summit The message will carry over to Obama’s April 12-13 summit in Washington, where he will host representatives from 46 nations, including Medvedev and Chinese President Hu Jintao , to seek consensus on steps to halt the spread of nuclear material. Obama’s strategy to build on START may have limits, said Sam Greene , deputy director of the Carnegie Moscow Center, a public-policy institution. “While the U.S. may try to make the most of the momentum it has gained with Russia, Moscow will want to maximize its room for maneuver in each specific case, whether on Iran, Afghanistan or any other major issue of concern to the U.S.,” Greene said in an e-mail. “Moscow will not want to feel tied down.” Obama made the prevention of nuclear terrorism a top goal of U.S. atomic policy this week as he revamped Cold War-era guidelines in the Nuclear Posture Review that defined limits on the role of nuclear weapons in defense. ‘Making Good’ “This signing of the treaty and this Nuclear Posture Review are two very tangible steps that, in effect, are making good on the promise of the vision” Obama described last year, Perry, who served in former President Bill Clinton ’s administration, said. The U.S. will set an example through START, said one advocate for eliminating nuclear weapons, Joseph Cirincione , who heads the San Francisco-based Ploughshares Fund , a nuclear policy group. “In order to get the cooperation you need to stop Iran from getting nuclear weapons, you’ve got to restore the credibility of the U.S. by reducing its own stockpile of weapons,” Cirincione said. The arm-reduction treaty also helps to lay the groundwork for next month’s non-proliferation treaty review talks in New York, analysts said. ‘Light Tower’ “It’s the light tower that tells the rest of the world what is the role of nuclear weapons,” said Micah Zenko , a fellow at the Center for Preventive Action at the Council on Foreign Relations . “The U.S. and Russia are not particularly safer because of this agreement, but because of the other sort of cooperation that it leads to, we are safer.” Some critics contend Obama should be focused less on incremental cuts in nuclear stockpiles and more on efforts to prevent countries, such as Iran, from gaining a weapon. The new START agreement doesn’t take into account “that we’re adding another country to the list of those who have nuclear weapons,” said Lawrence Eagleburger , who was secretary of state under former President George H.W. Bush. “Once Iran is a nuclear weapon state, there are bound to be other countries who look at this and say, ‘They are, we should be too,’” Eagleburger said in an interview. “Then it’s off to the races.” Administration officials counter that START is the latest effort to reset relations with Russia and say they hope it opens the way to greater cooperation to stop Iran’s nuclear ambitions. Russian View The U.S. says the treaty doesn’t restrict missile defenses to thwart an attack by states such as Iran and North Korea. That issue remains a sticking point with Russia, which has said it reserves the right to pull out of the accord if a U.S. system posed a threat to its nuclear arsenal. Foreign Minister Sergei Lavrov said April 6 Russia could exit the treaty if “the U.S.’s build-up of its missile defense strategic potential in numbers and quality begins to considerably affect the efficiency of Russian strategic nuclear forces.” To contact the reporter on this story: Julianna Goldman in Washington at jgoldman6@bloomberg.net

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Genital Herpes Virus Infects One in Six Americans, Study by U.S. CDC Finds

March 9, 2010

By Tom Randall March 9 (Bloomberg) — Genital herpes, a condition that produces painful sores and increases transmission of AIDS, has infected one in six Americans, according to a U.S. survey that shows prevention efforts haven’t stopped outbreaks. The study, conducted from 2005 through 2008, found the infection rate didn’t change significantly from a previous report from 1999 to 2004. It was released today by the U.S. Centers for Disease Control and Prevention in Atlanta. There’s no cure for herpes, which has two forms. Herpes simplex virus type 1 typically causes blisters known as cold sores near the mouth. Type 2 forms blisters near the genitals. Most infected people don’t know they have the virus and spread it to partners through sexual contact even when they’re not experiencing symptoms, according to the CDC . “This study serves as a stark reminder that herpes remains a common and serious health threat,” said Kevin Fenton , director of the CDC’s National Center for STD Prevention. “We are particularly concerned about persistent high rates of herpes among African-Americans, which is likely contributing to disproportionate rates of HIV in the black community.” The data were taken from the National Health and Nutrition Examination Survey, a federal report that draws from questionnaires and medical records. GlaxoSmithKline Plc’s Valtrex pill, approved to treat symptoms and reduce the frequency of outbreaks, had sales of $1.29 billion last year. The London-based company also makes an over-the-counter cream called Abreva, which shortens healing time and soothes infections. The amino acid lysine, available as a dietary supplement, has been found in studies to reduce symptoms and outbreaks. To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net .

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Genital Herpes Virus Infects One in Six Americans, Study by U.S. CDC Finds

March 9, 2010

By Tom Randall March 9 (Bloomberg) — Genital herpes, a condition that produces painful sores and increases transmission of AIDS, has infected one in six Americans, according to a U.S. survey that shows prevention efforts haven’t stopped outbreaks. The study, conducted from 2005 through 2008, found the infection rate didn’t change significantly from a previous report from 1999 to 2004. It was released today by the U.S. Centers for Disease Control and Prevention in Atlanta. There’s no cure for herpes, which has two forms. Herpes simplex virus type 1 typically causes blisters known as cold sores near the mouth. Type 2 forms blisters near the genitals. Most infected people don’t know they have the virus and spread it to partners through sexual contact even when they’re not experiencing symptoms, according to the CDC . “This study serves as a stark reminder that herpes remains a common and serious health threat,” said Kevin Fenton , director of the CDC’s National Center for STD Prevention. “We are particularly concerned about persistent high rates of herpes among African-Americans, which is likely contributing to disproportionate rates of HIV in the black community.” The data were taken from the National Health and Nutrition Examination Survey, a federal report that draws from questionnaires and medical records. GlaxoSmithKline Plc’s Valtrex pill, approved to treat symptoms and reduce the frequency of outbreaks, had sales of $1.29 billion last year. The London-based company also makes an over-the-counter cream called Abreva, which shortens healing time and soothes infections. The amino acid lysine, available as a dietary supplement, has been found in studies to reduce symptoms and outbreaks. To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net .

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Genital Herpes Virus Infects One in Six Americans, Study by U.S. CDC Finds

March 9, 2010

By Tom Randall March 9 (Bloomberg) — Genital herpes, a condition that produces painful sores and increases transmission of AIDS, has infected one in six Americans, according to a U.S. survey that shows prevention efforts haven’t stopped outbreaks. The study, conducted from 2005 through 2008, found the infection rate didn’t change significantly from a previous report from 1999 to 2004. It was released today by the U.S. Centers for Disease Control and Prevention in Atlanta. There’s no cure for herpes, which has two forms. Herpes simplex virus type 1 typically causes blisters known as cold sores near the mouth. Type 2 forms blisters near the genitals. Most infected people don’t know they have the virus and spread it to partners through sexual contact even when they’re not experiencing symptoms, according to the CDC . “This study serves as a stark reminder that herpes remains a common and serious health threat,” said Kevin Fenton , director of the CDC’s National Center for STD Prevention. “We are particularly concerned about persistent high rates of herpes among African-Americans, which is likely contributing to disproportionate rates of HIV in the black community.” The data were taken from the National Health and Nutrition Examination Survey, a federal report that draws from questionnaires and medical records. GlaxoSmithKline Plc’s Valtrex pill, approved to treat symptoms and reduce the frequency of outbreaks, had sales of $1.29 billion last year. The London-based company also makes an over-the-counter cream called Abreva, which shortens healing time and soothes infections. The amino acid lysine, available as a dietary supplement, has been found in studies to reduce symptoms and outbreaks. To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net .

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Pfizer’s Failures Clear Path for Cholesterol Drug Push by Canadian Upstart

March 5, 2010

By Ellen Gibson March 5 (Bloomberg) — Resverlogix Corp. , without a marketed product, may accomplish what Pfizer Inc. , the world’s biggest drugmaker, couldn’t: Creating a new medicine that fights heart disease by raising so-called good cholesterol. If the treatment, dubbed RVX-208, shows it can reverse the build-up of artery-clogging plaque, it may grab a “substantial” portion of the $35 billion cholesterol-fighting market, said Simos Simeonidis , an analyst with Rodman & Renshaw Inc. in New York. Resverlogix is in “detailed discussions” with several companies seeking to partner or license the drug, said Chief Executive Officer Donald McCaffrey , 51, in an interview. He declined to identify the potential partners. New York-based Pfizer spent more than $2 billion on two similar treatments without success. The drugs were tested by Steven Nissen , 61, the Cleveland Clinic cardiology chief who is leading the Resverlogix trials. Nissen said RVX-208 works differently than the Pfizer drugs, switching on a protein that helps spur the production of HDL, or good cholesterol. “There is definitely a lot of interest from big pharma” in Resverlogix’s drug candidate, said Simeonidis. “If this drug works, it could be as big as Lipitor.” Pfizer’s Lipitor, the world’s best-selling drug, generated $11.4 billion in revenue last year, according to data compiled by Bloomberg. Pfizer, Merck & Co. of Whitehouse Station, New Jersey, and Swiss drugmakers Novartis AG and Roche Holding AG “would potentially be interested” in co-developing RVX-208, Simeonidis said. He doesn’t have any specific knowledge of the companies’ interest, and all four declined to comment. Rising Shares Resverlogix rose 70 Canadian cents, or 18 percent, to C$4.50 in Toronto Stock Exchange trading yesterday. The shares have gained 86 percent this year. The company, which has a market value of C$177.4 million ($172 million), has no revenue. “What would make a good fit is a pharmaceutical company that has a strong cardiovascular position and an established sales network,” said McCaffrey, who co- founded the nine-year- old, Calgary-based drug developer. Prospective partners “may want to wait to see more data,” said analyst Simeonidis. “Then again, there’s such a huge potential they may be willing to take a flyer.” Best-selling heart drugs Lipitor and London-based AstraZeneca Plc’s Crestor lower production of so-called bad cholesterol, or LDL, by blocking an enzyme in the liver. These drugs belong to a class of medicines known as statins. New Approach Resverlogix’s product would increase the levels of a protein called ApoA-1 that helps produce HDL, which removes bad cholesterol from arterial plaque and ferries it to the liver where it can be disposed. People with naturally high levels of HDL are less likely to develop heart attacks or die from cardiovascular disease, studies show. Resverlogix is banking that artificially raising HDL will have the same effect. Only one treatment now commercially available is marketed to increase good cholesterol. Niacin, a B vitamin, elevates HDL “but it’s not clear whether it lowers cardiac events,” according to Stephen Kopecky , a cardiologist at the Mayo Clinic in Rochester, Minnesota. High doses of niacin are available in prescription form. Abbott Laboratories , based in Abbott Park, Illinois, makes Niaspan, the top-selling non-generic form of niacin. The drug generated $990 million in U.S. sales last year, according to Norwalk, Connecticut-based research firm IMS Health Inc. Facial Flushing Use of Niaspan has been limited because it can cause elevated blood sugar and facial flushing. In a 2009 study, one- third of patients newly treated with niacin reported severe to extreme flushing. Heart disease is the leading cause of mortality in the U.S., resulting in 632,000 deaths a year, according to the Centers for Disease Control and Prevention in Atlanta. In coronary artery disease, fat, cholesterol, calcium and other substances — collectively known as plaque — build up in the blood vessels that supply oxygen to the heart, a condition that can lead to a heart attack. A new class of medicines for combating the disease is “overdue,” according to the Cleveland Clinic’s Nissen, who said he doesn’t own Resverlogix stock and isn’t being paid for his RVX-208 research. Statins only reduce the risk of heart attack and stroke by 25 to 35 percent, he said. Water Supply “We could put statins in the water supply and heart disease would still be the leading cause of death in the developed world,” Nissen said in a telephone interview. Over the past decade, Nissen tested both of the experimental HDL medicines that passed through Pfizer’s pipeline. Pfizer acquired ApoA-1 Milano, a naturally occurring variant of the protein, through its $1.3 billion acquisition of Esperion Therapeutics Inc. in 2004. Once hailed as “ Drano for the heart ,” ApoA-1 Milano showed a reduction of plaque in early testing, according to a Nissen-written report published in the November 2003 issue of the Journal of the American Medical Association . The protein, mined from bacteria, turned out to be too difficult to produce. After conducting “extensive research into the large-scale manufacturing of ApoA-1 Milano,” Pfizer decided “to focus on other drug candidates in its portfolio,” company spokeswoman Anne Wilson said in an e-mail. The drugmaker sold the compound to Parsippany, New Jersey-based Medicines Company in December for $10 million and milestone payments if advances are made. Commercial Potential Nikhil Mehta , the director of cardiovascular portfolio at Decision Resources, a biopharmaceutical research firm based in Waltham, Massachusetts, said the commercial potential of RVX-208 is “much greater” than the failed Pfizer drug. “One of the main attractions of Resverlogix’s drug is that it is oral, unlike Milano, which was given as an infusion,” he said in a telephone interview. Pfizer also spent $1 billion attempting to develop the compound torcetrapib, a type of experimental medicine called a CETP inhibitor. CETP inhibitors aim to raise good cholesterol levels by blocking an enzyme that metabolizes HDL. The company at one point projected $13 billion in annual sales for torcetrapib as the successor to Lipitor, which faces generic competition in 2011. Development of the drug was halted in December 2006 when a study found that deaths among those on the medicine were 60 percent higher than among people who didn’t get it. Market Value Plunges Pfizer shares fell 11 percent on the first trading day after the announcement, wiping out $21 billion in market value, and the drugmaker later dropped most of its early heart-disease research. “Nissen kind of got burned” on torcetrapib, said Harlan Krumholz , a cardiologist at the Yale University School of Medicine in New Haven, Connecticut. “He was sure the CETP inhibitors were going to be great. Torcetrapib wasn’t, and it blew his hypothesis of saying, ‘I know what’s going to work and what’s not going to work.’” An early trial of RVX-208, concluded in August, met primary endpoints by safely increasing ApoA-1 levels by 5 to 10 percent in all 72 participants, Resverlogix said. The company finished enrolling patients in the next phase of testing on Feb. 8. In this study, about 280 patients with coronary artery disease will be dosed with Resverlogix’s experimental drug for 13 weeks to see how it affects their cholesterol levels. The company may present data from the study at the American Heart Association meeting in Chicago in November, CEO McCaffrey said. The company also is conducting a second mid-stage study involving 120 patients who suffered a heart attack in the four weeks before the trial began. The study will use ultrasound to measure plaque volume. Resverlogix obtained $30 million in financing in the past year, enough cash to pay for the current trials, McCaffrey said. If these studies are successful, Resverlogix plans to start the third and final round of testing needed for regulatory approval in mid-2011, McCaffrey said. Assuming all goes well, the company plans to file for approval with the U.S. Food and Drug Administration in 2015, he said. “Hope springs eternal,” Nissen said. “We need to keep trying to find an HDL-raising strategy that works.” To contact the reporters on this story: Ellen Gibson in New York at egibson9@bloomberg.net ;

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Brett King: Banks: KYC is Killing Your Customers

February 21, 2010

In my discussions with bankers about innovation, I often hear them tell me that perhaps in other industries innovation could be achieved, but due to heavy regulation and the compliance requirements of the banking sector that such is more difficult for financial institutions. This is part of the story, but I’m sure that it is fixable. I met with a Private Banker from one of the dominant bank brands in Asia this week. In Central Hong Kong this bank has it’s own tower, of which three floors are dedicated to the Private Banking unit, but that’s only half true. Almost half of that office space is taken up by a team that is designed to reduce risk to the bank by ensuring that customers are accurately informed of the risks their investments will carry, and to ensure that the bank does not commit itself or their client to undue risks. The name of this team within the Private Bank – the Business Prevention unit – I jest ye not. Has it come to this that regulation and risk aversion is such an important part of the bank that we now actively try to prevent business occurring? It would appear so. This explains a great deal about the current state of our banking sector. If customers are a risky proposition, then how does the bank make money? Well they invest it in stuff where they know they have an element of control, or in the case of sub-prime they try to actively engineer it so that they make profit regardless of the underlying asset risk. Some banks have even been known to borrow money from the government and margin trade on it in recent times… The point of this is that banks have become so myopic in respect to customer risk that as customer we’ve almost become an anathema. In fact, the compliance workload we as customers have to deal with these days is so offensive, that it is almost not worth engaging a bank for an investment deal or asking for a loan. To illustrate, in the mid 80′s I recall being a student and walking in to open an account with no identification, I filled out two cards with a specimen signature, my address and particulars, and that was it. Now that same bank requires a 100-point identification scorecard to be realized, and the basic current account application form is some 18 pages long. This is progress apparently. Internal bank compliance procedures are bad for business… Now, I appreciate we have Anti-Money Laundering, we have identity theft, we have IRS and tax departments eager to know what we’re doing with our money, and we have regulators that are making it their job to ensure we don’t invest in a financial product that we don’t fully understand. Sometimes, just sometimes, however, we just want a decent banking experience. We just want it to work, and the more paperwork you throw at us, the more hoops you make us jump through – the worse our banking experience is. The thing with this is, that although there are regulations and legal constraints, most of the work we have to do is due to internal bank policy and process. For example, let’s say an existing customer comes to the bank to ask for a loan – this is a customer we’ve known for 5 years, his salary gets paid every month on time, and he’s a low credit risk based on what we already know. Why then is it that this same customer has to fill out an application form with the same details he’s provided us with since day one? There is absolutely no regulatory or legal requirement for the process to be handled in this way. Right now this is all about making it easier for the bank to mitigate risk for their brand. A customer-focused bank would either allow the customer to sign on with their Internet Banking credentials to agree to the loan, perhaps sign on a tablet or digital form or if absolutely necessary generate a paper application form based on existing customer records where all he had to do was sign. All of these solutions would produce exactly the same result from a regulator’s or compliance perspective as a hefty paper KYC process. So why as banks don’t we do this way? Firstly, no one senior enough in the bank has sponsored such a move. Secondly, because the internal IT department would probably take 15,000 man days, and $184.63 m to enable this. And lastly, because at the end of the day as bank executives we get rewarded for mitigating bank risk, not for making customer experience better. Regulators and bankers need to separate ‘customer’ risk from operational risk, and in this way innovation can still occur.

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Limbaugh’s Barbs Test Palin’s Honest Outrage: Margaret Carlson

February 4, 2010

Commentary by Margaret Carlson Feb. 5 (Bloomberg) — I never thought it would come to this. Sarah Palin is going to have to unheart Rush Limbaugh. Otherwise the only conclusion is that she fakes her emotions, even those that seem most genuine. In her reaction to a remark by Rahm Emanuel , the crude White House chief of staff, her hurt seemed real. Last August, according to a Jan. 26 article in the Wall Street Journal, Emanuel called congressional liberals not supporting the president “retarded,” preceded by a favorite curse word of his. Palin called for his head. “Just as we’d be appalled if any public figure of Rahm’s stature ever used the ‘N-word’ or other such inappropriate language, Rahm’s slur on all God’s children with cognitive and developmental disabilities — and the people who love them — is unacceptable, and it’s heartbreaking,” Palin wrote on her Facebook page. Nothing about Palin is more appealing than her love for her child born with Down syndrome. Palin may wear her other children on her sleeve, and on stage, but Trig she holds in her heart. In the umbrage she took over a tasteless David Letterman joke about one of her daughters, her anger looked simulated. She dragged out that controversy well after the host said he was sorry. Here, her reaction was appropriate. Emanuel apologized privately to Tim Shriver , head of Special Olympics, which was started by his mother, Eunice , to encourage the developmentally disabled through sports. On Wednesday, Emanuel had Shriver and a number of disability groups come to the White House for a public apology. Double Derogatory Limbaugh took the occasion to double-down on Emanuel’s remark. On his radio show, Limbaugh made an even more derogatory comment, insisting that there can be no insult in “calling a bunch of people who are retards, retards.” The real news, Limbaugh continued, was that Emanuel had directed his “retard” comment at Obama supporters. “So now there’s going to be a meeting,” he said. “There’s going to be a retard summit at the White House.” Having called out Emanuel, Palin can’t let Limbaugh get away with his own “slur on all God’s children.” Surely Limbaugh qualifies as a “public figure,” one with far more reach than Emanuel. If a six-month-old Emanuel remark uttered at a private meeting broke her heart, Limbaugh’s rant must have crushed her. Limbaugh’s on-air claim yesterday that, in throwing around the word “retard,” he had been “just quoting Emanuel” is, of course, laughable. As for his observation that the “drive-by” media is “trying to goad Sarah Palin into denouncing” him for his remarks: Well, why not goad, even if we’re not as good at it as Rush is? More Than Crude Limbaugh’s reference to a “retard summit” wasn’t reflexive crudeness. He made the comment with malice aforethought, cloaked in his usual objection to political correctness, on which he bases his license to pick on the weak. His running shtick is that it’s rich white fuzzballs like him who really suffer in a warped society that punishes success. Palin, usually among Rush’s chosen strong, is among the weak in this instance. Mean words about her son touch a spot so tender she flinches. I get a slew of hate mail about my opinions, stupidity and hair. It comes with the privilege of writing a column. The only cruelty I can’t stand is against my mentally disabled brother. I spent much of my childhood forcing the neighborhood kids to choose him for their teams. Now that I’m his guardian, I run a Society for the Prevention of Cruelty to Jimmy. The need to protect never goes away. Triumph of Politics In Palin’s case, we’ll see if politics triumph. She will not want to treat Limbaugh as she did Emanuel, a political enemy. She and Limbaugh are in a mutual-admiration society, working the same side of the street, manning the barricades against the heathen liberals, enforcing the same pure strain of conservatism against infidels. Rush has a conscience. One reason his television show wasn’t as successful as his radio one was that he couldn’t play himself. Inside the cocoon of his radio studio, he exempts himself from the usual rules. He’s an entertainer, so he can say anything. He’s not a journalist, so he doesn’t need to be factual. Liberals are mushy-headed wimps, so he can attack those they coddle to even the score. Physical disability is not off limits. He went after Michael J. Fox with relish, performing a spastic chair dance while claiming that Fox had purposely not taken his medication so that his Parkinson’s disease would be on full display in a TV ad in favor of candidates supporting stem-cell research. (Not true, Fox said.) Maternal Instinct I have a lot of questions about Palin as a candidate for president but not about her maternal instinct. I bet she would give up everything if it would make her child well. I would for my brother. Politics has gotten much meaner since 1995, when I had a long interview with Rush as part of a cover package on him for Time magazine. I went in thinking he was a jerk but came away believing that underneath his jerky persona was a not-so-bad, hyperbolic talk jockey. Now, if he doesn’t apologize for his gratuitous cruelty, I’ll have to conclude that underneath that talk-show bluster, he’s a jerk. ( Margaret Carlson , author of “Anyone Can Grow Up: How George Bush and I Made It to the White House” and former White House correspondent for Time magazine, is a Bloomberg News columnist. The opinions expressed are her own.) Click on “Send Comment” in the sidebar display to send a letter to the editor. To contact the writer of this column: Margaret Carlson in Washington at mcarlson3@bloomberg.net

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Clinton Rejects Russia’s Call for New Europe Treaties, Says Troops to Stay

January 29, 2010

By Indira A.R. Lakshmanan Jan. 29 (Bloomberg) — U.S. Secretary of State Hillary Clinton rejected Russia’s calls for new European security treaties and said American forces will remain on the continent to “deter attacks and to respond quickly if any occur.” “European security remains an anchor of U.S. foreign and security policy,” Clinton said in a speech today in Paris, adding that “some questions” had been raised in recent months about the depth of the Obama administration’s commitment to Europe. Clinton dismissed two Russian initiatives seen as a bid to boost Russian influence over countries once part of the Soviet Union and the Warsaw Pact and to halt the North Atlantic Treaty Organization’s expansion. A plan put forward last month would have effectively given Russia a veto over allied military planning, especially in eastern Europe, said four allied officials who declined to be named. “The Russian government has put forth proposals for new security treaties for Europe,” Clinton said. “However, we believe that these common goals are best pursued in the context of existing institutions, such as the OSCE and the NATO-Russia Council, rather than by negotiating new treaties, as Russia has suggested.” The OSCE is the Vienna-based Organization for Security and Cooperation in Europe . Clinton said that a “cornerstone” of European security is the “sovereignty and territorial integrity of all states.” She repeated U.S. calls on Russia to honor the terms of a cease-fire agreement that ended the August 2008 Russia-Georgia war and the administration’s refusal to recognize Russia’s claims of independence for the breakaway Georgian regions of Abkhazia and South Ossetia. Spheres of Influence “More broadly, we object to any spheres of influence in Europe in which one country seeks to control another’s future,” Clinton said, adding that even amid Russian opposition, “ NATO must and will remain open to any country that aspires to become a member and can meet the requirements of membership.” Russian Prime Minister Vladimir Putin has accused NATO of violating a 1998 pledge not to permanently station “substantial combat forces” on former Warsaw Pact territory. NATO absorbed former Soviet allies starting in 1999 — including three former Soviet republics, Estonia, Latvia and Lithuania — at a time when a Russia shorn of its Cold War satellites was struggling to regain its economic footing after defaulting on $40 billion of debt. Under Putin since 2000, energy-rich Russia has seized on an oil price that peaked at $147 per barrel in July 2008 to revive its economy and gain leverage over oil- and gas-importing states in Europe. Russia Pushes Back Russia pushed back against further NATO enlargement with its 2008 invasion of Western-leaning Georgia and attempts to reassert control over Ukraine. The U.S. will maintain its “unwavering commitment” to Article 5 of the NATO treaty “that an attack on one is an attack on all,” said Clinton. “As proof of that commitment, we will continue to station American troops in Europe, both to deter attacks and to respond quickly if any occur,” she said. To be sure, Clinton underlined that even when Russia and the U.S. don’t agree “we will seek constructive ways to discuss and manage our differences.” She noted that “Russia is no longer our adversary” and pointed to Russian-U.S. cooperation on Afghanistan, Iran and North Korea. She also highlighted progress in discussions on a new START treaty to reduce the size of the Russian and U.S. nuclear arsenals. Cooperate With Russia Clinton said the U.S. is serious about exploring ways to cooperate with Russia to develop a missile defense system that would provide security for both Europe and Russia. “Missile defense we believe will make this continent a safer place,” said Clinton. “That safety could extend to Russia, if Russia decides to cooperate with us.” Clinton called on Russia to back the Conventional Forces in Europe Treaty and urged the Russian leadership to lift its two- year-old suspension of the implementation of the CFE Treaty. She said an updated treaty should take into account developments since the original treaty was signed in 1990 and include “the right of host countries to consent to stationing foreign troops in their territory.” The OSCE’s ability to defend and promote human rights needs to be strengthened and it needs a “Crisis Prevention Mechanism” that would allow it to send rapid humanitarian aid and provide impartial monitoring, Clinton said. NATO has pointed to the 56-nation Organization for Security and Cooperation in Europe , an East-West forum created in 1975, as the best arena for discussing Russia’s security concerns. “We are continuing the enterprise we began at the end of the Cold War to expand the zone of democracy and stability across Europe,” Clinton said. To contact the reporter on this story: Indira Lakshmanan in London at ilakshmanan@bloomberg.net .

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Heart Risk in One-Fifth of U.S. Teenagers Found by Lipid Tests, CDC Says

January 22, 2010

By Tom Randall Jan. 21 (Bloomberg) — A risk of heart disease in one-fifth of U.S. teenagers was identified through tests of lipids in the blood, showing the importance of diet, exercise and screening, according to U.S. researchers. Obese children were at the highest danger of abnormal lipid levels, with 43 percent testing outside the recommended ranges, according to today’s report by the U.S. Centers for Disease Control and Prevention in Atlanta. The report examined tests from 3,733 children ages 12 through 19 from 1999 to 2006. Lipids are fatty substances in the blood that can lead to plaque build-up in the arteries and early onset of heart disease. Most children with high lipid levels are recommended to get counseling to improve their diet and exercise routines, while adults also take cholesterol drugs including Pfizer Inc. ’s Lipitor and AstraZeneca Plc’s Crestor. About 1 percent of children have persistently high cholesterol treatable with drugs, according to the CDC. “It’s really important that we have an understanding of which youth warrant screening and therapeutic lifestyle screening early on,” said Ashleigh May, an epidemiologist at the CDC’s division of heart disease and stroke prevention, in an interview. “Parents should inquire about whether their child is eligible for this lipid screening, especially if their child is overweight or obese.” To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net .

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State Regulators Warn Of Failing Foreclosure Prevention Efforts

January 20, 2010

*This story has been updated* Lackluster foreclosure-prevention efforts and the dearth of principal reductions risk plunging more homeowners into foreclosure, state regulators warned Wednesday in a new report. Struggling homeowners are increasingly falling behind on their mortgage payments. Not enough of them are getting help from lenders, mortgage companies or the Obama administration’s foreclosure initiative. Worse, the backlog to get into a foreclosure-prevention program and to get permanent relief is growing. For the few homeowners that are helped, the relief comes with a cost: unpaid balances typically rise. “More troubling, more than 70 percent of modifications result in an increase in the principal amount owed,” according to the report by the State Foreclosure Prevention Working Group, a collection of 12 state attorneys general and three state banking supervisors (underlined in the original). This occurs because modification programs typically allow for mortgage companies to tack on delinquent amounts and any fees incurred by servicing to the mortgage principal. The Obama administration’s signature effort, the Home Affordable Modification Program, allows for this, too. This occurs despite estimates that at least one in four homeowners currently owe more on their home than it’s worth. Loan modification programs thus put these homeowners further “underwater.” Less than 10 percent of loan modifications through October of last year involved significant cuts to principal. “Given the correlation between negative equity and likelihood of default, the failure to write down principal in connection with loan modifications is a glaring flaw in current efforts,” the report notes. With so many homeowners underwater, “doing ‘business as usual’ only adds to the likelihood of ultimate default.” “The reality is that the housing bubble has burst,” Mark Pearce, North Carolina Chief Deputy Commissioner of Banks, said in a conference call with reporters. Those not addressing principal reduction as a means of reducing foreclosures are “close to being in denial,” he said. “We have to look at principal reductions.” The warning comes less than a week after the Obama administration detailed its progress in stemming the rising tide of foreclosures. While there has been some improvement, it’s largely because the bar was set so low. For example, the administration announced on Nov. 30 that about 375,000 homeowners in trial modifications would convert into permanent ones within four weeks; the administration hit just 18 percent of that target. In an interview, Richard H. Neiman , New York’s top bank regulator and a member of the Congressional Oversight Panel, the bailout watchdog, said he was going to press the Treasury Department further about HAMP’s low conversion rate. Meanwhile, foreclosures continue apace. Last year some 2.8 million homeowners entered foreclosure. More are expected this year. Though HAMP aims to reduce foreclosures, the program itself does not forbid mortgage companies from proceeding with foreclosure on HAMP-eligible homeowners. Instead, it merely keeps servicers from holding a final sale on the property. So homeowners often receive letters regarding their modifications while getting phone calls from other units of their servicer threatening foreclosure. “In some cases, homeowners have lost their homes while being told they are being considered for a loan modification,” the report notes. “This is unacceptable.” The group released its latest report in the hope of adding to the discussion and influencing policy. The report is based on data gleaned from 13 of the nation’s 20 biggest mortgage companies, which collectively service nearly 15 million mortgages. Among the findings: Just four out of 10 seriously delinquent borrowers are involved in loss-mitigation efforts. While programs like HAMP have increased that percentage, it’s been outpaced by the rising tide of delinquent loans. There’s a backlog in foreclosures and foreclosure-prevention efforts. There are seven loans in process in various foreclosure-prevention programs for every loan that’s actually resolved, a ratio that’s doubled in just the past year. Also, two years ago, the ratio of foreclosures-in-process to completed foreclosures was about 50 percent; it’s about 18 percent now. This “shadow inventory” of foreclosures could rock the housing market if they hit at once. Homeowners with good credit are increasingly falling behind. The number of prime loans at least 60 days past due shot up 66 percent over the past year. Prime loans make up 38 percent of all seriously delinquent loans, a figure that’s more than doubled in just two years. Based on those findings, and the lackluster Obama foreclosure-prevention efforts, state regulators issued a series of recommendations to “prevent unnecessary foreclosures.” Among them: Servicers should suspend foreclosure proceedings on any loan currently involved in a loss-mitigation process. Principal reduction must become more of a priority, particularly in areas where homeowners are suffering from significant price declines like California, Nevada and Florida. The Treasury Department needs to be more transparent, particularly with regards to the formula it uses to judge homeowners’ eligibility for the HAMP program. Servicers and the Obama administration need to develop a plan to help unemployed homeowners. HAMP requires them to document that they are entitled to at least nine months of unemployment insurance to qualify for a HAMP modification, the report notes. With the official unemployment rate at 10 percent (millions more are either out of the workforce or struggling to make ends meet by working part-time rather than full-time), current efforts are ill-equipped to help them stay in their homes. *Due to an editing error, the story misstated what the state attorneys general and banking superintendents said about the Obama administration’s foreclosure-prevention efforts. Programs like HAMP have helped homeowners, just not as much as would have been hoped. State officials also noted that the crisis would have been much worse had the administration not acted.* READ the report below: State Foreclosure Prevention Working Group, Jan. 2010 – Get HuffPost Business On Facebook and Twitter !

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Haiti’s Health System Crumbles Under Earthquake as Disease Outbreaks Loom

January 15, 2010

By Tom Randall, Meg Tirrell and Michelle Fay Cortez Jan. 15 (Bloomberg) — The earthquake in Haiti crushed the country’s fragile infrastructure for health care and clean water and may trigger widespread outbreaks of life-threatening diarrhea, measles and malaria. Access to clean water, antibiotics and basic health supplies are top concerns, said Giuseppe Annunziata, coordinator of the emergency response and recovery operations at the World Health Organization . The agency is setting up monitoring systems so it can quickly respond to disease outbreaks. Haiti has long suffered the highest rates of malnutrition and lack of access to basic medical services in the Western Hemisphere, according to the WHO, a Geneva-based agency of the United Nations. Disease outbreaks may be worse than in the aftermaths of comparable natural disasters because the crisis has wiped out the country’s health infrastructure, said Thomas Kirsch, director of operations at Johns Hopkins School of Medicine’s department of emergency medicine in Baltimore. “This is such a delicate situation,” said Margaret Aguirre, a spokeswoman for the emergency response team of International Medical Corp. , a nonprofit based in Santa Monica, California, in a telephone interview yesterday from Port-au- Prince. “We need to bring in medical supplies ourselves. So much of the infrastructure is lost in terms of buildings and personnel. A lot of the people who normally do relief work are missing themselves.” Doctors set up operations outside the main hospital in Port-au-Prince, because the building isn’t stable, Aguirre said. The epicenter of the 7.0 magnitude earthquake was close to the Haitian capital. “There have been many, many aftershocks,” she said. Flourishing Diseases Diarrheal diseases , including cholera and E. coli, cause severe dehydration and strip the body of needed nutrients. Diarrhea will flourish as survivors struggle to find clean water and safe food, Kirsch said. Children are most susceptible to severe infections. Measles outbreaks, which sometimes follow natural disasters, may flash through neighborhoods of tightly packed courtyards where thousands of homeless residents are gathering. Measles spreads rapidly and kills 15 percent of infected children in regions with malnutrition, Thomas Frieden , director of the U.S. Centers for Disease Control and Prevention, said in an interview in December. “The health system has been eliminated, water and sanitation entirely knocked out,” Kirsch said in an interview yesterday. “The chance of them recovering even to the low level that they were before is almost zero.” Water Bladders It’s critical in the next few days to set up portable bladders of water, which look like 40-foot-wide balloons, Kirsch said. Aid agencies must also establish temporary treatment centers throughout Port-au-Prince and deliver tons of antibiotics and medical supplies, he said. Half of the children in Haiti are unvaccinated and just 40 percent of the population had access to basic health care before the crisis, according to the WHO. After a natural disaster of this magnitude, the delivery of needed supplies is usually managed by the military, Kirsch said. In Haiti, the armed forces were dismantled in 1995. The UN typically coordinates aid from international agencies. Those efforts were hampered after the headquarters of the UN’s 9,000-person security mission in Haiti collapsed. The UN reported 36 of its staff dead, including 4 police, 19 soldiers and 13 civilians and 188 employees missing. ‘Poorly Governed’ “Haiti is considered one of the most poorly governed countries in the world,” said Egbert Sondorp, a senior lecturer in public health and humanitarian aid at the London School of Hygiene and Tropical Medicine . “It’s a fragile state which wasn’t very well able to provide social and health services to its population even before the earthquake.” The initial period of medical crisis, when rescuers look for people buried beneath the rubble and care for those with the most severe injuries from the earthquake, will last just a few days, Sondorp said in a telephone interview. The bigger challenge, and one that could take decades to resolve, is rebuilding the infrastructure needed to provide food, clean water and health care to citizens nationwide, he said. “It’s quite essential, as soon as you can, to come up with a proper rehabilitation plan,” he said. “You need to get people together to pool resources and do common planning that will make the conditions better.” Drugmaker Donations Drug companies Pfizer Inc., GlaxoSmithKline Plc, and Abbott Laboratories are donating needed medicines and medical supplies. New York-based Pfizer Inc. , the world’s biggest drugmaker, is giving medicines including the antibiotic Zithromax to fight bacteria and Diflucan for fungal infections, said Pfizer spokeswoman Tyrene Frederick-Mack in a telephone interview. The earthquake may already have killed 45,000 to 50,000 people, Victor Jackson, an assistant national coordinator with Haiti’s Red Cross, told Reuters. Haitian Prime Minister Jean-Max Bellerive said Jan. 13 in an interview with CNN that “well over” 100,000 may have died, basing his estimate on reports of the number of buildings that collapsed with people inside. The American Red Cross estimates as many as 3 million people may be affected by the earthquake. Haiti has a population of 9.6 million, with about 2 million located in Port-au-Prince. The Western Hemisphere’s poorest country, Haiti has a per capita income of about $560, with 54 percent of Haitians living on less than $1 a day and 78 percent on less than $2 daily, according to the Washington-based World Bank . Traumatic Injuries “Immediately we’re dealing with a very significant amount of physical trauma-related injuries which are going to be responsible for virtually all of the prompt fatalities,” said Irwin Redlener , director of the National Center for Disaster Preparedness at Columbia University Mailman School of Public Health. The chance of survival plummets for someone buried under rubble after 48 to 72 hours, he said in an interview yesterday. When those with more serious injuries are being treated, people with broken bones and other more moderate ones can get infections while they wait. “The fact that the system is overloaded spells trouble even for people with moderate injuries,” Redlener said. After the initial period, “the rubble itself creates hazards. We start seeing lots of cuts, bruises, falls,” he said. Chronic illnesses, such as diabetes or asthma, that were previously under control may become exacerbated with lack of medical care or the inability of people to obtain medicines, Redlener said. Some will develop stress-related disorders from emotional trauma. “The emotional burden of this is going to be overwhelming,” he said. Doctors Without Borders The aid group Doctors Without Borders has had more than 1,000 patients in its four tented medical facilities in Port-au- Prince, according to a statement. Many people have fractures, head injuries and other major trauma, and food, water and shelter materials are running low, the group said. “Basic provisions were always problematic for people in Port-au-Prince but the position is far worse now,” said Vincent Hoedt, an emergency coordinator for the group, in the e-mailed statement. “There’s a concern for people who are already weakened by injuries. There are also shortages of things like gasoline, which affects the working of all kinds of vital equipment.” Half in Slums Port-au-Prince had 21 public health facilities, including four hospitals, before the earthquake, according to Greg Elder, deputy operations manager for Doctors Without Borders in Haiti. Half of the city’s inhabitants lived in slums, Elder said yesterday in an e-mailed update from the organization. “It’s a really catastrophic event where absolutely no one knows really what the scope of this is in terms of casualties and fatalities,” Elder said. Doctors Without Borders has almost 800 staff members in Port-au-Prince and plans to send 70 more people to help in the next few days, including several surgical teams, Elder said. A flight was scheduled to leave yesterday with equipment to establish a 100-bed inflatable tent hospital with two operating rooms, and two surgical teams were leaving from Miami, he said. The U.S. Department of Health and Human Services is deploying 250 people and 22,000 pounds of medical equipment and supplies, with more than 12,000 personnel able to assist in coming days, the department said in a statement. Seeking Help Lester Hartman, a Westwood, Massachusetts, pediatrician and Harvard Medical School faculty member, said he expects to see greater demand for services at Mt. Carroll Clinic, which he helped establish in 2003 in the town of Juampas , about 40 miles (64 kilometers) outside Port-au-Prince. While the clinic, where Hartman is medical director, wasn’t harmed by the earthquake, survivors will soon begin arriving in hill towns such as Juampas in search of food and medical services, he said. “There’s going to be a secondary wave of people migrating from Port-au-Prince to the towns,” he said in a Jan. 13 interview in Boston. “They’ll come up to live with relatives and they won’t have housing or food. So people who don’t have enough food to begin with will have to split their food.” Food supplies may remain scarce because most deliveries come to the country via Port-au-Prince, Hartman said. He’s also looking for ways to deliver extra doses of antibiotics. Hartman said he may fly into the Dominican Republic capital city of Santo Domingo and drive eight hours to Juampas to avoid the chaos of Port-au-Prince . Workers in the clinic, which typically serves about 300 people each week, often see temporary migration from Port-au- Prince to hill towns during riots, Hartman said. The displacing effects of the earthquake may last much longer, he said. “Think of it a little bit like Katrina,” he said. “People are going to need help for years.” To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net ; Meg Tirrell in New York at mtirrell@bloomberg.net ; Michelle Fay Cortez in London at mcortez@bloomberg.net

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Haiti Survivors Face Diarrhea, Malaria Outbreaks Amid Lack of Clean Water

January 14, 2010

By Tom Randall, Meg Tirrell and Michelle Fay Cortez Jan. 14 (Bloomberg) — Survivors of the earthquake in Haiti that may have killed as many as 100,000 people face deadly outbreaks of diarrhea, measles and malaria after its already fragile clean water and health-care systems were destroyed. Even before the bodies of the dead have been removed from the rubble, health officials say it’s critical in the next few days that massive containers of water be set up throughout the capital of Port-au-Prince, temporary treatment centers established and tons of antibiotics and basic medical supplies delivered. Haiti has long suffered from the highest rates of malnutrition and lack of access to basic health services in the Western Hemisphere, according to the World Health Organization . The crisis has left no health infrastructure for aid workers to build upon, and disease outbreaks may be worse than in the aftermaths of comparable natural disasters, said Thomas Kirsch, director of operations at Johns Hopkins School of Medicine’s department of emergency medicine in Baltimore. “This is such a delicate situation,” said Margaret Aguirre, a spokeswoman for the emergency response team of International Medical Corp., a non-profit based in Santa Monica, California, in a telephone interview from Port-au-Prince. “We need to bring in medical supplies ourselves. So much of the infrastructure is lost in terms of buildings and personnel. A lot of the people who normally do relief work are missing themselves.” Doctors have set up operations outside the main hospital, because the building isn’t stable, according to Aguirre. The epicenter of the 7.0 magnitude earthquake was close to the city. “There have been many, many aftershocks,” she said. Flourishing Diseases Diarrheal diseases, including cholera and e. coli, cause severe dehydration and strip the body of needed nutrients. Diarrhea will flourish as survivors struggle to find clean water and safe food, Kirsch said. Children are most susceptible to severe infections. Measles outbreaks, which sometimes follow natural disasters, may flash through neighborhoods of tightly packed courtyards where thousands of homeless residents are gathering. Measles spreads rapidly and kills 15 percent of infected children in regions with malnutrition, Thomas Frieden , director of the U.S. Centers for Disease Control and Prevention, said in an interview in December. “The health system has been eliminated, water and sanitation entirely knocked out,” Kirsch said in an interview today. “The chance of them recovering even to the low level that they were before is almost zero.” No Basic Care Half of the children in Haiti are unvaccinated and just 40 percent of the population had access to basic health care before the crisis, according to the Geneva-based WHO. After a natural disaster of this magnitude, the delivery of needed supplies is usually managed by the military, Kirsch said. In Haiti, the armed forces were dismantled in 1995. The UN typically coordinates aid from international agencies. Those efforts were complicated after the UN headquarters at the Christopher Hotel collapsed in the quake. UN Assistant Secretary-General for Peacekeeping Operations Alain LeRoy said 14 workers in Haiti were confirmed dead, and 150 civilian and military personnel are unaccounted for. Other UN offices have also been damaged, and 10 people are missing from a compound that houses these groups. ‘Poorly Governed’ “Haiti is considered one of the most poorly governed countries in the world,” said Egbert Sondorp, a senior lecturer in public health and humanitarian aid at the London School of Hygiene and Tropical Medicine. “It’s a fragile state which wasn’t very well able to provide social and health services to its population even before the earthquake.” The initial period of medical crisis, when rescuers look for people buried beneath the rubble and care for those with the most severe injuries from the earthquake, will last just a few days, Sondorp said in a telephone interview. The bigger challenge, and one that could take decades to resolve, is rebuilding the infrastructure needed to provide food, clean water and health care to citizens nationwide, he said. “It’s quite essential, as soon as you can, to come up with a proper rehabilitation plan,” he said. “You need to get people together to pool resources and do common planning that will make the conditions better.” Drugmaker Donations Drug companies are donating needed medicines and medical supplies. New York-based Pfizer Inc., the world’s biggest drugmaker, is giving medicines including the antibiotic Zithromax to fight bacteria and Diflucan for fungal infections, said Pfizer spokeswoman Tyrene Frederick-Mack in a telephone interview. GlaxoSmithKline Plc, based in London, sent antibiotics on one of the first airlifts to Haiti after the earthquake, said spokeswoman Claire Brough in a telephone interview. The drugs included Bactroban cream and ointment, Augmentin for respiratory tract infections, Zovirax for herpes virus, Ceftin and Zinacef for bacterial infections and Zantac for heartburn and stomach ulcers, she said. The company plans to extend donations once the local infrastructure is repaired, she said. Abbott Laboratories, based in Abbott Park, Illinois, is donating $1 million in grants and pharmaceutical and nutritional products. Eli Lilly & Co., based in Indianapolis, is contributing $250,000, matching employee donations, and plans to donate medicines, the company said in the statement. Death Toll Estimates The earthquake may already have killed 45,000 to 50,000 people, Victor Jackson, an assistant national coordinator with Haiti’s Red Cross, told Reuters. Haitian Prime Minister Jean-Max Bellerive said yesterday in an interview with CNN that “well over” 100,000 may have died, basing his estimate on reports of the number of buildings that collapsed with people inside. The Red Cross estimates as many as 3 million people may be affected by the earthquake. Haiti has a total population of 9.6 million, with about 2 million located in Port-au-Prince. The Western Hemisphere’s poorest country, Haiti has a per capita income of about $560, with 54 percent of Haitians living on less than $1 a day and 78 percent on less than $2 daily, according to the World Bank. Traumatic Injuries “Immediately we’re dealing with a very significant amount of physical trauma-related injuries which are going to be responsible for virtually all of the prompt fatalities,” said Irwin Redlener , director of the National Center for Disaster Preparedness at Columbia University Mailman School of Public Health. The chance of survival plummets for someone buried under rubble after 48 to 72 hours, he said in an interview today. When those with more serious injuries are being treated, people with broken bones and other more moderate ones can get infections while they wait. “The fact that the system is overloaded spells trouble even for people with moderate injuries,” Redlener said. After the initial period, “the rubble itself creates hazards. We start seeing lots of cuts, bruises, falls,” he said. Chronic illnesses, such as diabetes or asthma, that were previously under control may become exacerbated with lack of medical care or the inability for people to obtain medicines, Redlener said. Some will develop stress-related disorders from emotional trauma. “The emotional burden of this is going to be overwhelming,” he said. Doctors Without Borders The aid group Doctors Without Borders has had more than a thousand patients in its four tented medical facilities in Port- au-Prince, according to a statement. Many people have come in with fractures, head injuries and other major trauma, and food, water and shelter materials are running low, the group said. “Basic provisions were always problematic for people in Port-au-Prince but the position is far worse now,” said Vincent Hoedt, an emergency coordinator for the group, in the e-mailed statement. “There’s a concern for people who are already weakened by injuries. There are also shortages of things like gasoline, which affects the working of all kinds of vital equipment.” Port-au-Prince had 21 public health facilities, including four hospitals, before the earthquake, according to Greg Elder, deputy operations manager for Doctors Without Borders in Haiti. Half of the city’s inhabitants lived in slums, Elder said in an e-mailed update from the organization. “It’s a really catastrophic event where absolutely no one knows really what the scope of this is in terms of casualties and fatalities,” Elder said. Flights Depart Doctors Without Borders has almost 800 staff members in Port-au-Prince and plans to send an additional 70 people to help in the next few days, including several surgical teams, Elder said. A flight will leave today with equipment to establish a 100-bed inflatable tent hospital with two operating rooms, and two surgical teams are leaving today from Miami, he said. Lester Hartman, a Westwood, Massachusetts, pediatrician and Harvard Medical School faculty member, said he expects to see greater demand for services at Mt. Carroll Clinic, which he helped establish in 2003 in the town of Juampas, about 40 miles outside Port-au-Prince. While the clinic, where Hartman is medical director, itself was unscathed by the earthquake, survivors will soon begin arriving in hill towns such as Juampas in search of food and medical services, he said. Food Supplies “There’s going to be a secondary wave of people migrating from Port-au-Prince to the towns,” he said yesterday in an interview in Boston. “They’ll come up to live with relatives and they won’t have housing or food. So people who don’t have enough food to begin with will have to split their food.” Food supplies may remain scarce because most deliveries come to the country via Port-au-Prince, Hartman said. He’s also looking for ways of bringing extra doses of antibiotics. Hartman said he may fly into the Dominican Republic capital city of Santo Domingo and drive eight hours to Juampas to avoid the chaos of Port-au-Prince. Workers in the clinic, which typically serves about 300 people each week, often see temporary migration from Port-au- Prince to hill towns during riots, Hartman said. The displacing effects of the earthquake on may last much longer, he said. “Think of it a little bit like Katrina,” he said. “People are going to need help for years.” To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net

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Diarrhea May Act as a Source of Infection for Influenza, Researchers Find

January 8, 2010

By Jason Gale Jan. 8 (Bloomberg) — Diarrhea in flu-infected children may harbor the virus, scientists found, pointing to a previously unrecognized source of infection. Tests on 733 children with influenza-like illness and an upset tummy found a minority of patients had seasonal strains in their stool and live viral particles were retrieved from one case. The finding, published yesterday in the journal BioMed Central , suggests that flu may invade the gastrointestinal tract, potentially acting as a mode of transmission. The research may help explain why gastric symptoms, including diarrhea and vomiting , afflicts about one in five people with swine flu, the H1N1 strain that emerged last year and touched off the first influenza pandemic in 41 years. The study is believed to be the largest to investigate flu virus detected in the gastrointestinal tract of children with flu-like illness and diarrhea, the authors wrote. “To date, limited autopsy data have not indicated detection of 2009 H1N1 virus outside the respiratory tract in humans, but further studies are needed,” said Tim Uyeki , a study author and flu epidemiologist at the U.S. Centers for Disease Control and Prevention in Atlanta. The presence of viable virus particles in the gut “has implications for transmission and infection control,” he said in an e-mail today. Uyeki and colleagues at Indonesia’s National Institute of Health Research and Development and the U.S. Naval Medical Research Unit No. 2 in Jakarta tested the children, who were all younger than 6 years. Genetic material from the flu virus was found in 12 percent of nose and throat swabs and 3 percent of stool samples, the authors wrote in the open-access publication. Live Virus Viable type-B flu particles were recovered in the stool of one child, a finding possibly explained by active infection in the gastrointestinal tract, the researchers said. The patient could also have swallowed the virus from an infection in the nose or throat, they said. It’s possible flu might infect and actively replicate within cells in the gastrointestinal tract similar to the way in which influenza viruses replicate in bird species, they said. “It has been known for quite a long time that young children with seasonal influenza experience diarrhea more frequently than adult patients, especially with influenza B virus infection,” Uyeki said. To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net .

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Cocktail of Alzheimer’s Therapies More Effective Than 1 Treatment in Study

January 6, 2010

By Meg Tirrell Jan. 6 (Bloomberg) — Alzheimer’s disease may be better treated with a cocktail of therapies that limit production of plaque that impairs the brain rather than with one treatment alone, a study in mice suggests. The combination approach preserved memory with few side effects, something individual treatment methods haven’t been able to do as well, researchers at Johns Hopkins University School of Medicine said in a report published today in the journal Science Translational Medicine . There’s no cure yet for Alzheimer’s , a disease that attacks the brain and causes memory loss that can devolve into severe cognitive decline. It affects an estimated 30 million people worldwide and was the sixth-leading cause of death in the U.S. in 2007, according to the Centers for Disease Control and Prevention in Atlanta. Scientists suspect Alzheimer’s may be caused by a protein called amyloid beta , generated by two enzymes that drugmakers have been targeting individually with experimental treatments. “The idea is if you can identify compounds or drugs that inhibit these enzymes, you’ll be able to slow down the progression of the disease,” said Philip Wong, a professor in the pathology and neuroscience departments at Baltimore-based Johns Hopkins who was a senior author of the study. “One of the major issues is side effects.” Two enzymes known to spur formation of amyloid beta that afflicts brain function are beta-secretase and gamma-secretase, both targets in Wong’s study of mice. Drugs in Development Drugmakers such as Eli Lilly & Co. , GlaxoSmithKline Plc , Pfizer Inc. and Bristol-Myers Squibb Co. are working on Alzheimer’s treatments that aim to inhibit either the beta- or gamma-secretase enzyme, Wong said. Lilly’s semagacestat, a gamma-secretase inhibitor, is in the final stage of human trials generally required for U.S. approval, the company said in December. The idea of targeting both enzymes simultaneously is “completely novel,” Wong said. Drugs will have to be approved for use individually before they would be able to be combined, making the prospect of human testing with a potential cocktail years away, he said. Completely blocking either of the enzymes can cause side effects such as skin cancer, schizophrenia-like symptoms and shortened lifespan, Wong said. Partially inhibiting them, though, cut the side effects and still helped reduce plaque production, said Wong. Combined Attack Using that information, the researchers looked at what would happen if both enzymes were simultaneously limited without being blocked entirely. The scientists found the combination more effectively reduced plaque build-up without the side effects in mice, according to the report. “It suggests this would be a terrific therapeutic strategy,” Wong said. “Eventually the combination of these two drugs as a cocktail would prove to be most efficacious.” To model how the drugs might work, the researchers altered mice genetically to carry the Alzheimer’s gene. One group had reductions in both enzymes, one a reduction in gamma-secretase, and one a reduction in beta-secretase. A fourth Alzheimer’s group was left alone, and a fifth group — the control — consisted of normal mice without the gene. The researchers used a maze set in water to chart how well the different groups were able to remember directions, and found that mice with reductions in both enzymes performed “nearly as well” as the control group, while others did poorly, Wong said. “You don’t need to hit these enzymes too hard,” Wong said. “If you can show some efficacy without the side effects, you can begin to combine the two inhibitors.” To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net .

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Antidepressants Don’t Help Patients With Mild Disorders, Researchers Find

January 6, 2010

By Simeon Bennett Jan. 6 (Bloomberg) — Antidepressants such as those made by GlaxoSmithKline Plc may be no better than dummy pills for people with mild or moderate depression, according to a study that suggests 70 percent of patients wouldn’t benefit from the drugs. In a review of six trials of antidepressants involving more than 700 patients published yesterday in the Journal of the American Medical Association, researchers led by Jay Fournier at the University of Pennsylvania found the drugs helped only those patients with the most severe depression. Most trials excluded patients with milder forms of the disorder, the authors said. About 70 percent of patients have a form of depression below the level at which they would benefit from medication, Fournier and colleagues wrote, citing a 2002 study. Doctors, policy makers and sufferers should be made aware that there’s little evidence to show the treatments will benefit patients with less severe symptoms, the authors said. “This important feature of the evidence base is not reflected in the implicit messages present in the marketing of these medications to clinicians and the public,” they said. The researchers combined data from six trials, including three of paroxetine, the main ingredient in London-based Glaxo’s Paxil and Seroxat pills, and three of imipramine, an older generic medicine. The drugs had a “nonexistent to negligible” effect on patients with mild, moderate and severe symptoms, compared with those who took a placebo, according to a commonly used scale used to measure the disorder. The pills had a large effect on patients with very severe symptoms, the study found. ‘Important Option’ “The studies used for the analysis in the JAMA paper differ methodologically from studies used to support the approval of paroxetine for major depressive disorder, so it is difficult to make direct comparisons between the study results,” Glaxo spokeswoman Claire Brough said in an e-mail. “Antidepressants are an important option, in addition to counseling and lifestyle changes, for treatment of depression.” The findings of the study are “probably going to have some beneficial impact on doctors who may be less experienced” in treating depression, said Michael Baigent, an associate professor of psychiatry and clinical adviser to Beyond Blue , a Melbourne, Australia-based organization that seeks to raise awareness of the disorder. “It may also filter through to consumers, and help them in their understanding of depression,” Baigent said in a telephone interview today. Almost 16 percent of people in the U.S. had been diagnosed with depression at some time in their lives, the Centers for Disease Control and Prevention found in a 2006 survey of 35 states. Worldwide sales of antidepressants reached $20.3 billion in 2008, according to IMS Health Inc. Debate The study is the latest to challenge the health benefits of antidepressants since the drugs became available in the 1950s. Research has linked antidepressants with suicidal thoughts, birth defects and a life-threatening neurological disorder. Studies have also shown the medicines can impair male fertility, curb female libido and interfere with a breast cancer drug. In 2004, the U.S. Food and Drug Administration began requiring a black box, the most serious type of warning for prescription drugs, to be added to labeling of all antidepressants to warn about the increased risk of suicidal thoughts and behavior in children and adolescents being treated with the medications. The study was funded by the Bethesda, Maryland-based National Institute of Mental Health. To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

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Obesity Becomes Shionogi Gamble in Search for Another Crestor Blockbuster

December 22, 2009

By Kanoko Matsuyama Dec. 22 (Bloomberg) — Persistence may pay off for Shionogi & Co. as it struggles to turn a promising scientific advance into a best-selling diet pill. The Japanese company, discoverer of the blockbuster cholesterol medicine Crestor, plans to stick with velneperit, an experimental obesity drug, after one of two key studies failed and Merck & Co. , Johnson & Johnson and GlaxoSmithKline Plc abandoned similar treatments. Shionogi is betting on a world market with the potential to expand 20-fold to $10.5 billion by 2018, according to estimates by London-based Datamonitor Plc. Even if it should eventually gain regulatory approval, velneperit may not be enough to offset the potential drop in annual sales when Crestor loses patent protection in 2016, said Gareth Powell , a fund manager in London. “I’ve not been impressed with the drug,” said Powell, who invests in health-care stocks for Polar Capital Partners Ltd., the manager of $2 billion of assets. “If they relied on this as the sole replacement of Crestor, I’d be pretty nervous.” Powell’s holdings don’t include Shionogi shares. Analysts at Barclays Plc in London and at Mitsubishi UFJ Securities Co. and Mizuho Securities Co. , both of Tokyo, are omitting the product from revenue estimates for Osaka-based Shionogi. The drugmaker needs velneperit and AIDS treatments it is developing with Glaxo to make up for the revenue plunge foreseen for Crestor, which now accounts for a quarter of Shionogi’s 223 billion yen ($2.5 billion) in annual sales, when the cholesterol drug loses patent protection in less than seven years. Side Effects Drugmakers have failed to find a weight-loss formula without side effects. Wyeth, now a unit of New York-based Pfizer Inc., pulled its fen-phen diet pill in 1997 and put aside $21 billion to settle a decade of litigation after the drug combination was linked to heart and lung damage. Paris-based Sanofi-Aventis SA dropped its weight-loss drug Acomplia, which the company had expected to generate $3 billion a year, in October 2008 after European regulators deemed that the risks of the pill outweighed its benefits. The drug had failed to win backing from a U.S. Food and Drug Administration panel in June 2007 over reports of suicide risks. Merck, of Whitehouse Station, New Jersey, and Pfizer stopped developing drugs similar to Acomplia. For drugmakers, the allure of the weight-loss market is hard to resist. The world had at least 400 million obese adults in 2005, a figure that may jump 75 percent to 700 million by 2015, according to the Geneva-based World Health Organization . Overweight and obese people face greater risk of heart attacks, strokes and diabetes than those with less body mass, according to the U.S. Centers for Disease Control and Prevention, based in Atlanta. Damped Sales Product withdrawals and failed treatments in the pipeline have hurt global sales of obesity drugs, which totaled $514 million last year, Datamonitor said. The number of obese adults in seven markets, including the U.S. and U.K., will climb at least 14 percent to 143 million in the decade to 2018, and assuming that a quarter of them will be treated for a year at $1 a day, the market could swell to $10.5 billion, the research company said. Velneperit is a gamble, as the latest tests showed that patients taking the drug shed 4.6 percent of their weight. While that compared with 1.2 percent for those given a placebo, medicines from Orexigen Therapeutics Inc. of La Jolla, California, and Vivus Inc. of Mountain View, California, have advanced further in development and yielded more weight loss. Without Velneperit Shionogi rose 1.1 percent to close at 1,949 yen in Tokyo trading. The stock has dropped 18 percent in the past 12 months, compared with a 6.4 percent gain for Japan’s benchmark Topix Index . For now, Shionogi is commanding growing sales and profit without help from its obesity drug, said Yasuhiro Nakazawa , an analyst at Mitsubishi UFJ Financial Group Inc. in Tokyo. The drugmaker’s operating profit will climb more than 20 percent annually through March 2013, Nakazawa said. He is one of 13 analysts, among 17 tracked by Bloomberg, who recommend buying Shionogi shares, citing sales led by Crestor . Shionogi, which discovered Crestor, sold rights to the drug to AstraZeneca Plc’s forerunner Zeneca Group in April 1998. In October, Shionogi halted its search for a partner to help develop velneperit outside Japan, as the company planned to carry out more studies to achieve a stronger result on the drug’s efficacy, President Isao Teshirogi said at an analysts’ briefing in November. Promising Test The company announced in February the outcome of two clinical tests, in the second of three stages required by regulators. One shows some promise: 35 percent of patients on a restricted diet who took velneperit for 54 weeks lost more than 5 percent of their weight, almost three times the proportion for those who were given a dummy pill. In the other test, there was little weight-loss difference between patients taking the drug and those on placebo. “The efficacy just wasn’t all that exciting,” Polar Capital’s Powell said. Shionogi is conducting new trials of velneperit in combination with an older medicine, Xenical from Basel, Switzerland-based Roche Holding AG. The Japanese company expects results around November 2010, pushing back by one year what had been its schedule to enter the final stage of development. The delay means the drug may not reach the market in time to help make up for Crestor’s patent expiration, said Hiroshi Tanaka , an analyst at Mizuho Securities in Tokyo. Advanced Drug Testing Besides the obesity pill, only one drug originating from Shionogi is in advanced stages of patient studies in the U.S., the world’s largest pharmaceutical market. The company is working with Glaxo on an HIV treatment that blocks an enzyme the virus uses to hijack healthy cells. Alpharetta, Georgia-based Sciele Pharma Inc., owned by Shionogi, has at least two drugs in advanced development: a spray to prevent premature ejaculation, and Adrenamate, a treatment for anaphylaxis, a potentially deadly allergic reaction. Shionogi said it is sticking with velneperit because the treatment shows more promise than Merck’s MK-0557. In one study involving dieting patients, Merck’s drug showed the test subjects regained some weight after finishing treatment. When combined with weight-loss medicines sold by Abbott Laboratories of Abbott Park, Illinois, and Roche, the drug didn’t show as much benefit as those products alone. Velneperit works by blocking a receptor called neuropeptide Y5, which plays a role in food cravings. ‘Can do Better’ “Merck tried everything it could and gave up,” Takuko Y. Sawada, Shionogi’s head of drug development, said in an interview from its laboratory in Osaka. The Japanese company “can do better” because of differences in the way velneperit shows its effect on weight management, Sawada said. Merck ended development of MK-0557 for obesity in 2005. The weight loss after one year of treatment wasn’t clinically meaningful, Ian McConnell , a Merck spokesman, said in an e-mail. Glaxo, Johnson & Johnson and Novartis also stopped testing drugs in the same class as MK-0557. “The human response to food is extremely complex,” McConnell said. “It appears that interfering with one pathway may not have a dramatic effect because there could be other pathways serving as backup systems that compensate for the change caused by the drug.” Terminated Project Melinda Stubbee, a spokeswoman for London-based Glaxo, said its project was no longer active. Ernie Knewitz , a spokesman for New Brunswick, New Jersey-based J&J, said development of its drug stopped several years ago. Eric Althoff , a spokesman at Basel, Switzerland-based Novartis, said its project was terminated. All three didn’t elaborate. Targeting Y5 alone probably can’t reduce body weight by much more than 5 percent because humans eat as a form of protection, said Herbert Herzog , head of the neuroscience research program at the Garvan Institute of Medical Research in Sydney. “As soon as you are starving and your body feels like your energy level is low, it’s driving you toward feeding,” Herzog said. “You are not programmed not to eat.” The U.S. FDA published guidance for the industry in February 2007 on developing medicines for weight loss. Products must meet at least one of two benchmarks. The first requires a minimum difference of 5 percentage points between weight loss from the drug and that from a placebo; otherwise, at least 35 percent of the group taking the drug must lose no less than 5 percent of body weight and the effect must be seen in twice as many patients as those on placebo. Rival Drugs Arena Pharmaceuticals Inc. , of San Diego, and Vivus plan to submit their respective obesity treatments, lorcaserin and Qnexa, to the FDA this year. Orexigen has said it will present its medicine, Contrave, in the first half of 2010. Most of those drugs combine at least two proven treatments to get around the need to eat. Contrave mixes an antidepressant with a narcotic. “Appetite is a fundamental function that humans can’t survive without,” said Kazuhiko Tatemoto, who co-discovered neuropeptide Y. “There are many pathways that control appetite so if you deactivate one, others get activated.” To contact the reporter on this story: Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net .

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Japan Mask Wearing, Tamiflu Rush Beat Swine Flu Better Than U.S., Europe

December 10, 2009

By Kanoko Matsuyama and Jason Gale Dec. 11 (Bloomberg) — Eight hours after Tokyo office worker Shungo Yamamoto started feeling feverish and faint, he got a diagnosis of swine flu, received antiviral drugs and embarked on three days of self-imposed isolation last month. “I knew it was influenza immediately” because of the fever and joint pain, Yamamoto, 25, said. His doctor confirmed the diagnosis with a nose swab test and prescribed five days of Roche Holding AG’s antiviral drug Tamiflu. When he left the doctor’s office, Yamamoto put on a mask, bought a three-day supply of food, rented DVDs and headed home, where he stayed for the duration of his illness. Japan’s aggressiveness against H1N1 influenza, the result of hygiene standards, social etiquette and a willingness to test and medicate immediately, means the country has fared better than the U.S. or the U.K. in battling the first pandemic in 41 years. A World Health Organization report shows Japan’s mortality rate is 2 deaths for every 100,000 people. The rate is higher by 11 times in the U.K., 16 times in the U.S. and 43 times in Australia. “No doctor in Japan would tell a flu patient just to go home and sleep it off,” said Norio Sugaya , a pediatric specialist at Keiyu Hospital in Yokohama, a port city south of Tokyo. Sugaya sits on a committee that advises WHO, a Geneva- based arm of the United Nations, on managing swine flu patients. In the U.K., a study this month found patients typically waited three days to start taking Tamiflu, one of two medicines available to fight the new virus as well as seasonal influenza. Complication Risk The U.S. Centers for Disease Control and Prevention , based in Atlanta, recommends that antiflu drugs be given to hospitalized patients, pregnant women and others with increased risk of complications. In Japan, doctors are advised to administer the medicines to anyone suspected of having flu, even if a rapid diagnostic test is negative, according to the Japanese Association for Infectious Diseases , a Tokyo-based organization of specialist doctors that provides treatment recommendations. Japan accounted for three-quarters of the Tamiflu dispensed globally in the drug’s first five years of sale, Roche, based in Basel, Switzerland, said in a November 2005 filing to the U.S. Food and Drug Administration. Three years later, Japan’s government announced plans to stockpile enough antiflu medicines for 45 percent of its 128 million people. That may be triple the amount required to treat every swine flu patient. The proportion of people sickened by the pandemic virus ranges from 7 percent to 15 percent, depending on the country, according to WHO. Japanese Practices Japan’s status as one of the biggest users of antiviral medicines and its approach to treating seasonal and pandemic flu should be compared with practices elsewhere and the data should be published in English, said Lance Jennings , a clinical virologist with Canterbury Health Laboratories in Christchurch, New Zealand, who has studied flu for more than 30 years. “If you have better capacity to diagnose cases earlier and are treating appropriately and early, you’re more likely to reduce the number of patients who will go on to develop more- severe influenza,” Jennings said in an interview. While the majority of pandemic flu sufferers got over their illness within days without treatment, 1 percent to 10 percent needed hospitalization and as many as a quarter of those patients required intensive care, WHO said on Dec. 4 . Early Treatment Tamiflu and Relenza, an inhaled medicine made by London- based GlaxoSmithKline Plc , appear beneficial in fighting the H1N1 virus, especially if treatment begins within 48 hours of the onset of symptoms, researchers said in a study in the New England Journal of Medicine in November. A paper in the same journal in December reported reduced complications, including deaths, among hospitalized patients treated with the medications. A survey of Japanese patients in 2005 found 85 percent sought medical treatment for flu and 90 percent of consultations took place within 48 hours after the first symptoms appeared, according to David Reddy , who heads Roche’s influenza task force in Basel. “These people do not wait until it’s too late,” Reddy said in a telephone interview. “Japan has to be the gold standard of management of influenza. It’s almost a societal response in terms of the way people modify their behavior.” Japanese have become accustomed during the past decade to wearing masks in public to ward off allergic reactions to pollen from cedar trees throughout the country, said Masataka Yoshikawa , a researcher who tracks consumer behavior at Hakuhodo Institute of Life and Living, the research arm of a Tokyo-based advertising company. Japanese expect someone with a cold or flu to wear a mask to limit the spread of the virus, he said. Wash and Gargle “Hand-washing, gargling and wearing masks are three hygiene measures that are very well accepted in the community in Japan,” said Nikki Shindo , the Japanese doctor who is leading WHO’s investigation of swine flu patients. “People don’t really hesitate to wear masks in public places. Even the 24/7 convenience stores sell high-particulate respirators at a reasonable price.” Some researchers say they are skeptical that Tamiflu is effective and concerned that the virus will develop resistance to the drug because of misuse. An analysis of 20 studies published in the British Medical Journal on Dec. 8 showed Tamiflu offered mild benefits for healthy adults and found no proof it prevented lower respiratory tract infections or complications of flu. There is little evidence to show that otherwise healthy people should be given Tamiflu routinely, the researchers said. ‘No Doubt’ “Based on our analysis and other subsequent work, there is no doubt that the drug can reduce complications,” said Frederick Hayden , a professor of clinical virology at the University of Virginia School of Medicine in Charlottesville, who was one of the first doctors to study Tamiflu in patients. Missing doses or failing to complete a course of medicine increases the risk that a drug-evading strain will emerge, said William Aldis , an assistant professor of global health at Thammasat University in Bangkok and a former WHO representative to Thailand. In societies such as Japan, where treatment compliance is high, patients are less likely to contribute to drug resistance, he said. “So this is one more reason to think carefully before applying Japan’s approach elsewhere,” Aldis said. Japan, whose flu season typically peaks between January and March, may face more deaths from H1N1 if the infection trend follows that of seasonal flu, said Hitoshi Oshitani , a virology professor at Tohoku University in Sendai, in northern Japan. “Japan will enter its regular peak flu season from now, and we have to observe whether the pattern continues or not,” he said. Oshitani, who advises WHO on pandemic strategies for developing nations, also credits the country’s school-closure program for helping battle swine flu. To contact the reporters on this story: Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net ; Jason Gale at j.gale@bloomberg.net .

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Measles Deaths Drop 78 Percent in Eight Years Under Global Vaccine Effort

December 3, 2009

By Tom Randall Dec. 3 (Bloomberg) — Measles deaths declined 78 percent in the last eight years as a global vaccination campaign inoculated 700 million children and saved 4.3 million lives. About 164,000 people died from measles last year, compared with 733,000 in 2000, according to a report released today by the U.S. Centers for Disease Control and Prevention and the World Health Organization . While measles deaths dropped almost 17 percent in the last year alone, health officials said there are signs that progress in fighting the disease is slowing. Measles , the world’s leading cause of death in children, is a contagious respiratory illness spread through coughing and sneezing. The CDC and WHO worked with poor countries to increase use of a two-dose vaccine that costs about $1 to administer. India, which wasn’t a part of the collaboration, now accounts for about 75 percent of worldwide deaths from the virus. “Today’s news shows the power of vaccination,” CDC Director Thomas Frieden said in a conference call today. “India, where one-third of the world’s unvaccinated infants live, still has a ways to go.” The vaccine should be given to all children before their first birthday, with a second dose at 18 to 24 months, according to the American Red Cross . The agency is part of the collaboration, known as the Measles Initiative, which is a mix of governments, companies and aid organizations that help poor countries buy and distribute shots. Measles Initiative In regions with poor vaccination coverage, the initiative helps provide shots to all children ages 9 months to 15 years regardless of vaccination history. For some children it will be a second shot, for others their first. A single shot prevents the disease for the majority of children. India plans to start a two-dose vaccination campaign in about half the country’s states beginning next year. Measles symptoms include rash, high fever, cough, runny nose and reddened, watery eyes. Some people also develop an ear infection, diarrhea, lung infection or brain inflammation. The disease kills as few as 1 in 1,000 children who are infected in developed countries and 15 percent or more of infected children in regions with malnutrition, the CDC’s Frieden said. The Measles Initiative is $59 million short of the fundraising goals needed to meet its goals next year, the group said in a statement. Health authorities from the CDC and WHO said they fear government complacency and a lack of funding may quickly reverse the progress made against measles, resulting in an additional 1.7 million deaths from 2010 to 2013. To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net .

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Swine Flu Fight Gets `Window of Opportunity’ as U.S. Vaccine Supply Gains

December 1, 2009

By Tom Randall Dec. 1 (Bloomberg) — Declining infection rates for swine flu and a greater supply of vaccine have opened a “window of opportunity” to protect people against the illness, said the director of the U.S. Centers for Disease Control and Prevention. About 70 million doses of vaccine are now available, and supply will be increasing in coming weeks, Thomas Frieden , the head of the CDC, said today in a conference call. Flu rates have dropped to their lowest in about two months, offering an opportunity for people to get vaccinated to head off the possibility of a new wave of infections of H1N1 influenza. Visits to U.S. doctors by patients with flu symptoms have declined for four straight weeks, and widespread illness was reported in just 32 states, the fewest since September, according to the CDC. Hospitalizations, deaths and doctor visits remain higher than usual for this time of year though within the range experienced during the course of a typical flu season. “There’s been a decline in activity, but there’s still a lot of flu,” Frieden said today in a briefing at the Atlanta- based CDC. “We’re far from out of the woods, but we have an opportunity to get more people protected in case there’s another surge or wave in future months.” To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net

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Chinese Drywall Leads To Corrosion In Homes

November 23, 2009

WEST PALM BEACH, Fla. — The federal government said Monday that it has found a “strong association” between problematic imported Chinese drywall and corrosion of pipes and wires, a conclusion that supports complaints by thousands of homeowners over the last year. In its second report on the potentially defective building materials, the U.S. Consumer Product Safety Commission said its investigation also has found a “possible” link between health problems reported by homeowners and higher-than-normal levels of hydrogen sulfide gas emitted from the wallboard coupled with formaldehyde, which is commonly found in new houses. The commission, along with the Environmental Protection Agency and the Centers for Disease Control and Prevention, continues to study the potential health effects, and the long-term implications of the corrosion. “We can say that we believe that there’s a number of different chemicals that when brought together can be related to some of these irritant health effects that we’ve been getting reports of,” said CPSC spokesman Scott Wolfson. “But we’re still working toward that exact nexus.” The commission said it can now move forward with additional studies to identify effective remediation of the problem and potential assistance from the federal government. However, Warren Friedman of the U.S. Department of Housing and Urban Development said it’s too soon to discuss specifics of any financial assistance homeowners could get. The CPSC has spent more than $3.5 million on the studies, and has received more than 2,000 homeowner complaints from 32 states, Washington, D.C., and Puerto Rico, in what is now the largest consumer product investigation in U.S. history. Most of the complaints have come from Florida, Louisiana, and Virginia. Wolfson said the CPSC has committed nearly 15 percent of its staff to the issue. The results released Monday came, in part, from a 51-home indoor air quality study. However, officials cautioned that not all Chinese drywall is necessarily problematic and that homes with American-made drywall also are being studied. “Not all drywall is alike,” said Jack McCarthy, president of Environmental Health & Engineering Inc., the firm hired by the government to perform the air quality tests. “It depends on what it’s made of, not necessarily the country where it came from.” Added Wolfson: “We are not limited in the scope of our investigation to just Chinese drywall.” The commission released its first report on the drywall last month, noting further studies were needed before it could consider a recall, ban or other action. Thousands of homeowners who bought new houses built with the imported Chinese building product are finding their lives in limbo as hundreds of lawsuits against builders, contractors, suppliers and manufacturers wind through the courts. During the height of the U.S. housing boom, with building materials in short supply, American construction companies imported millions of pounds of Chinese-made drywall because it was abundant and cheap. An Associated Press analysis of shipping records found that more than 500 million pounds of Chinese gypsum board was imported between 2004 and 2008 – enough to have built tens of thousands of homes. They are heavily concentrated in the Southeast, especially Florida and areas of Louisiana and Mississippi hit hard by Hurricane Katrina. The suspect building materials have previously been found by state and federal agencies to emit “volatile sulfur compounds” and produce a rotten-egg odor. Homeowners complain the fumes are corroding copper pipes, destroying TVs and air conditioners, blackening jewelry and silverware, and making them sick. The federal government says China is assisting with the investigation. ___ On The Net: http://www.cpsc.gov/info/drywall/index.html

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Swine Flu Deaths Double Almost Every Two Weeks in Europe; 670 Since April

November 23, 2009

By Jason Gale Nov. 23 (Bloomberg) — Swine flu deaths have doubled almost every two weeks since mid October in Europe, with 169 occurring in the past week, the European Center for Disease Control and Prevention said. Across the region, 670 people infected with the new H1N1 influenza strain have died since April, the Stockholm-based ECDC said today in a report on its Web site. Cases are being reported in all European Union and European Free Trade Association countries, ECDC said. The infection, which causes little more than a sore throat, fever and a cough in the majority of cases, has hospitalized more than 4,400 people in Europe to date. Among those, the U.K. has 180 H1N1 patients in intensive care units, France has 81, the Netherlands 38, Norway 24 and Ireland 20, ECDC said. “While the most deaths have to date been in Western Europe, there are increasing numbers of deaths being reported from Central and Eastern Europe,” the ECDC said in its daily report. The number of deaths is three more than the agency stated in an earlier version of the report obtained by Bloomberg News before its scheduled release at 9 a.m. central European time. H1N1 accounts for more than 99 percent of flu samples tested in Europe, indicating the pandemic virus has supplanted seasonal strains in the region, said John Paget , an epidemiologist at the Netherlands Institute for Health Services Research in Utrecht who monitors flu patterns for the World Health Organization’s euroflu.org . More than 19,000 specimens were positive for H1N1 in Europe during the week ended Nov. 15, Paget said in a telephone interview last week. ‘So Many Positive Specimens’ “Normally in flu a season we would have a maximum of 3,000,” he said. “We have never seen so many positive specimens reported per week since 1996, when we started collecting data.” Italy, Norway and Sweden reported a “very high intensity” of influenza-like illness or acute respiratory illness in the past week, the ECDC said. Intensity was “high” in Bulgaria, Denmark, Germany, Iceland, Ireland, Lithuania, Luxembourg, Poland and Portugal. The remainder reported predominantly “medium” intensity, it said. The peak of infections has probably occurred in some countries such as Belgium and Ireland, Paget said. In Belgium’s worst week, flu cases reached the fifth highest in a decade, while Ireland’s peak was the highest in about 10 years, he said. “We are not seeing spectacularly high ILI rates if you look at historical data,” Paget said. He said no accurate data are available to compare the number of hospitalizations caused by swine flu and the number that occur due to seasonal influenza. To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net

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Swine Flu Deaths Double Almost Every Two Weeks in Europe; 667 Since April

November 23, 2009

By Jason Gale Nov. 23 (Bloomberg) — Swine flu deaths have doubled almost every two weeks since mid-October in Europe, with 166 occurring in the past week, the European Center for Disease Control and Prevention said. Across the region, 667 people infected with the new H1N1 influenza strain have died since April, the Stockholm-based ECDC said today in a report obtained by Bloomberg. Cases of the pandemic flu are being reported in all European Union and European Free Trade Association countries, it said. The infection, which causes little more than a sore throat, fever and a cough in the majority of cases, is increasing hospital admissions. The U.K. has 180 H1N1 patients in intensive care units, France has 81, the Netherlands 38, Norway 24 and Ireland 20, according to the ECDC. To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net

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Flu Shot Made From Caterpillars Fails to Prove Safety, FDA Advisers Find

November 19, 2009

By Tom Randall Nov. 19 (Bloomberg) — Protein Sciences Corp. failed to prove its experimental flu vaccine is safe enough to be approved and more study is needed, a U.S. advisory panel said. The shot, called FluBlok, is produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells. Members of the advisory panel to the U.S. Food and Drug Administration voted 6-to-5 that the company hadn’t proven the vaccine safe, saying clinical trials weren’t large enough to support mass production. Nine of the 11 panelists said the shot was as effective as licensed vaccines in adults ages 18 to 49. Closely held Protein Sciences, based in Meriden, Connecticut, and backed by $147 million in U.S. contracts, is seeking to become the country’s first supplier to break from the 50-year-old technique of growing the vaccine in chicken eggs. The egg-based process has been blamed for delays in this year’s pandemic swine flu vaccine, and U.S. health officials have pledged to increase production times. “The reason we’re struggling so much is the safety database isn’t very large,” said Pamela McInnes, director of the Division of Extramural Research at the National Institutes of Health and one of the panelists. “The company has clearly done some nice work, and there’s been a lot of progress made. There’s not a signal in my mind that I’m very worried, but we are missing information.” Patient Hospitalized There were several examples of face swelling reported in clinical trials, and one person was hospitalized for a condition called pleuropericarditis, characterized by swelling around the heart and lungs. While the hospitalized patient had reported fever, shortness of breath and chest pain a week before he was vaccinated, the shot couldn’t be ruled out as a contributor to his illness, panelists said. Staff documents released by the FDA ahead of today’s panel hearing said the vaccine was found to be as safe and effective as other flu shots in four human trials covering 3,231 adults ages 18 and older. Panelists today said that because the vaccine wasn’t significantly more effective than competitors, the company needed to prove safety in larger trials in order to justify approval. While the FDA usually follows its panels’ recommendations, the agency isn’t required to do so. The new swine flu strain identified in April has infected 22 million Americans and killed about 3,900, according to the Atlanta-based CDC. More people with flu symptoms sought treatment from doctors in October and November than at the February peak of a normal flu season, according to data on the CDC Web site . The U.S. flu season runs from November to March. Vaccine Delays Vaccine to combat the swine flu, known as H1N1, began arriving in October, and about 50 million doses are available for shipment, health officials said yesterday. That’s less than half what officials projected in July for the end of October. Novavax Inc. , which has enrolled 1,000 recipients in clinical trials of a competing technology, rebounded in Nasdaq Stock Market composite trading on the panel’s decision. The shares fell 4 cents, or 1 percent, to $3.77 at 4 p.m., after declining as much as 6.6 percent during the meeting. The Rockville, Maryland-based company makes a vaccine from virus- like particles, structures that mimic the flu without causing infection. Early Bets Novartis AG , based in Basel, Switzerland, London-based GlaxoSmithKline Plc and Baxter International Inc. based in Deerfield, Illinois, made early bets on a method of growing the live vaccine in cultured animal cells. Novartis, which sells vaccine using the cell-based technique in Europe, received U.S. contracts for $487 million to build a production plant in North Carolina. The animal-cell process, which relies on growing the live virus in cells, may prove less dependable than Protein Sciences’ technique, said William Schaffner , chairman of the department of preventive medicine at Vanderbilt University in Nashville, Tennessee, before today’s meeting. “Variability is gone, the egg allergy is gone, purity increases so it can be much more refined — that’s exciting to us,” Schaffner, who is a consultant for the U.S. Centers for Disease Control and Prevention’s advisory committee on vaccines, said in a telephone interview. “We are at the beginning of some major changes in influenza vaccine technology.” Not Necessarily Faster Animal cell-based technology isn’t necessarily faster than egg-based, Philip Hosbach, vice president of immunization policy and government relations for the vaccine unit of Paris-based Sanofi-Aventis SA , said yesterday at a congressional oversight hearing in Washington. Vas Narasimhan , president of Novartis’s U.S. vaccine unit, said the cell-based method may save six to eight weeks of production time. “The big companies are going with mammalian cells, which really doesn’t make any sense,” said Daniel Adams , chief executive officer of Protein Sciences, in a telephone interview before the panel met. “You’re substituting mammalian cells for eggs, but you still have to use a live virus. You still have to wait for a seed strain from the CDC. “People for a long time thought you could deal with a pandemic using eggs,” Adams said. “My gut reaction is that change comes slowly, but I certainly expect our technology to be a major player in the flu.” Adams didn’t immediately return a phone call for comment after the panel vote. Cell-Based Shots Novartis’s cell-based vaccines for seasonal flu and swine flu, approved for use in Europe, show the safety and effectiveness of the production method, company spokesman Eric Althoff said in an e-mail. The drugmaker’s technique produced the first batch of swine flu vaccine, he said. “Existing technologies are here now; they’re tried and true,” Donna Cary , a spokeswoman for Sanofi, said today in a telephone interview. She said Sanofi is evaluating new vaccine technologies including cell-based production and a so-called universal vaccine that would cover all strains and wouldn’t need to be re-administered each year. A Glaxo representative couldn’t be reached. Most seasonal flu vaccines are made by taking versions of the three most-commonly circulating influenza strains and growing the virus in millions of chicken eggs. The virus is then removed from the eggs and damaged so it can’t cause infections. Some strains grow faster than others, and a poorly performing seed virus such as the pandemic swine flu, can delay production, which typically take 5 to 6 months. Caterpillar Virus Protein Sciences extracts genes from the dead flu virus and inserts it in a virus that feeds on a tropical caterpillar known as an armyworm . The virus is then exposed to ovary cells harvested from a single caterpillar and reproduced in large quantities. Ovary cells are used because they remain stable as they are cultured in a laboratory. The caterpillar virus feeds on the ovary cells in vessels similar to those used to ferment beer, and there isn’t the variability of trying to grow a live flu virus that isn’t well adapted for chicken eggs, said Adams of Protein Sciences. The consistency of the caterpillar virus growth cuts down on the manufacturing time. The end result is a vaccine made of protein and salt water, he said. Because the vaccine is pure, preservatives such as thimerosal aren’t necessary. Protein Sciences fought off an involuntary bankruptcy suit by creditor Emergent BioSolutions Inc. in September. In addition to its government contracts, the company is funded by private investors including Wyeth, which was acquired by New York-based Pfizer Inc. for $68 billion in October. To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

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Flu Shot Made From Caterpillars May Win Pivotal Backing of U.S. Advisers

November 19, 2009

By Tom Randall Nov. 19 (Bloomberg) — Protein Sciences Corp. may win backing from a U.S. panel today for a flu vaccine that can be produced in a third of the time it takes Sanofi-Aventis SA , GlaxoSmithKline Plc and Novartis AG to make their shots. The shot, called FluBlok, is produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells. Closely held Protein Sciences, backed by $147 million in U.S. contracts, is seeking to become the country’s first supplier to break from the 50-year-old technique of growing the vaccine in chicken eggs. The vaccine supply for this year’s pandemic swine flu strain is behind schedule, prompting U.S. health officials to blame the egg-based process and call for new technologies to increase the response time. Kathleen Sebelius , U.S. secretary of health and human services, awarded contracts in June to Meriden, Connecticut-based Protein Sciences and pledged last month to upgrade the country’s vaccine plants. “People may have just heard about Protein Sciences, but that doesn’t mean they haven’t been working for a decade on it,” said Gregory Poland , head of the vaccine research group at the Mayo Clinic College of Medicine in Rochester, Minnesota. “Other companies are either going to have to adapt to the new technology or they’re going to have to invent or develop even better ones.” Poland, who worked on one of FluBlok’s clinical trials, said the new method must be proven reliable with large-scale production during a flu season before most manufacturers would consider switching from eggs. He predicts egg-based vaccines will be phased out in three to five years as new techniques are adopted. FDA Review Staff documents released by the Food and Drug Administration ahead of today’s panel hearing said clinical trials found the vaccine as safe and effective as other flu shots in four human trials covering 3,231 adults ages 18 and older. Results from the trials were insufficient to judge whether the vaccine worked as well as existing shots for those ages 65 and older, according to the documents. While the FDA usually follows its panels’ recommendations, the agency isn’t required to do so. The new swine flu strain identified in April has infected 22 million Americans and killed about 3,900, according to the Atlanta-based CDC. More people with flu symptoms sought treatment from doctors in October and November than at the February peak of a normal flu season, according to data on the CDC Web site . The U.S. flu season runs from November to March. Vaccine to combat the swine flu, known as H1N1, began arriving in October, and about 50 million doses are available for shipment, health officials said yesterday. That’s less than half what officials projected in July for the end of October. Animal Cells Novartis, based in Basel, Switzerland, London-based Glaxo and Baxter International Inc. based in Deerfield, Illinois, made early bets on a method of growing the live vaccine in cultured animal cells. Novartis received U.S. contracts for $487 million to build a production plant in North Carolina to use the technique. That process, which relies on growing the live virus in cells, may prove less dependable than Protein Sciences’ technique, said William Schaffner , chairman of the department of preventive medicine at Vanderbilt University in Nashville, Tennessee. “Variability is gone, the egg allergy is gone, purity increases so it can be much more refined — that’s exciting to us,” Schaffner, who is a consultant for the U.S. Centers for Disease Control and Prevention’s advisory committee on vaccines, in a telephone interview. “We are at the beginning of some major changes in influenza vaccine technology.” Egg-Based Animal cell-based technology isn’t necessarily faster than egg-based, Philip Hosbach, vice president of immunization policy and government relations at Sanofi’s vaccine unit, said yesterday at a congressional oversight hearing in Washington. Vas Narasimhan, president of Novartis’s U.S. vaccine unit, said the cell-based method may save six to eight weeks of production time. “The big companies are going with mammalian cells, which really doesn’t make any sense,” said Daniel Adams , chief executive officer of Protein Sciences, in a telephone interview. “You’re substituting mammalian cells for eggs, but you still have to use a live virus. You still have to wait for a seed strain from the CDC. “People for a long time thought you could deal with a pandemic using eggs,” Adams said. “My gut reaction is that change comes slowly, but I certainly expect our technology to be a major player in the flu.” Donna Cary , a spokeswoman for Sanofi, didn’t return a telephone call seeking comment. Novartis spokesman Eric Althoff didn’t reply to an e-mail. A Glaxo representative couldn’t be reached. Chickens vs. Caterpillars Most seasonal flu vaccines are made by taking versions of the three most-commonly circulating influenza strains and growing the virus in millions of chicken eggs. The virus is then removed from the eggs and damaged so it can’t cause infections. Some strains grow faster than others, and a poorly performing seed virus such as the pandemic swine flu, can delay production, which typically take 5 to 6 months. Protein Sciences extracts genes from the dead flu virus and inserts it in a virus that feeds on a tropical caterpillar known as an armywor m. The virus is then exposed to ovary cells harvested from a single caterpillar and reproduced in large quantities. Ovary cells are used because they remain stable as they are cultured in a laboratory. More Consistent The caterpillar virus feeds on the ovary cells in vessels similar to those used to ferment beer, and there isn’t the variability of trying to grow a live flu virus that isn’t well adapted for chicken eggs, he said. The consistency of the caterpillar virus growth cuts down on the manufacturing time. The end result is a vaccine made of protein and salt water, Adams said. Because the vaccine is pure, preservatives such as thimerosal aren’t necessary. Protein Sciences has grown to 63 employees from 40 in the last three months, and if the vaccine is approved, it may be the smallest company to receive an FDA drug approval, Adams said. The company may have shots ready for next flu season, he said. “We can turn on a dime,” he said. “That’s part of the greatness of the technology.” To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

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Seasonal Flu Shots Don’t Protect Against Swine Flu Strain, U.S. Study Says

November 12, 2009

By Tom Randall Nov. 12 (Bloomberg) — Seasonal flu shots didn’t protect against the new swine flu strain that’s now responsible for 99.6 percent of U.S. infections, according to a federal study. Patients who were vaccinated in the 2008-2009 flu season were just as likely as unvaccinated people to become infected during the first wave of the swine flu pandemic, according to today’s study by the U.S. Centers for Disease Control and Prevention in Atlanta. The study supports findings from a similar analysis in Australia, where scientists found no evidence of any effect from the seasonal vaccine on swine flu. Swine flu, or H1N1, infected as many as 5.7 million Americans from April through July, according to the CDC. The outbreak is at its highest level now and is responsible for almost 8 percent of U.S. doctor visits, the agency said. “These results, taken together with other studies, do not support an effect of seasonal 2008-2009” vaccine on swine flu, CDC scientists said in an editorial following the study in the agency’s Morbidity and Mortality Weekly Report . “Results from additional studies using more rigorous study designs and methods currently under way in the U.S. and other countries will further define seasonal influenza vaccine effectiveness.” Previous studies from Mexico and Canada showed conflicting results, with the Mexico study showing a protective effect from the seasonal vaccine and a cluster of five Canadian studies showing that the seasonal vaccine actually increased chances of contracting swine flu. The report from Mexico may have been skewed by the people chosen for the study, and the Canadian studies haven’t been published yet, according to the CDC. The CDC study compared vaccination rates of 356 people who contracted swine flu with rates among people who stayed healthy, finding no significant difference. It also supports studies that showed levels of swine flu protective antibody in the blood aren’t affected by the seasonal flu vaccine. To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

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Demand for Swine Flu Vaccine Rises, Adding to U.S. Shortage, CDC Says

October 27, 2009

By Meg Tirrell Oct. 27 (Bloomberg) — The swine flu vaccine shortage is boosting demand from Americans concerned they won’t get the product in time to hold off the disease, said Thomas Frieden , director of the Centers for Disease Control and Prevention . The amount available to doctors and clinics starting this week will have risen to 22.4 million doses from about 14 million on Oct. 21, Frieden said today. The supply is still smaller than needed, he said. A U.S. health official has blamed the shortage on production delays at two drugmakers, and one manufacturer’s failure to gain regulatory approval for its product. President Barack Obama declared swine flu a national emergency Oct. 24. The disease, also known as H1N1 influenza, is widespread across the country and accounts for 411 confirmed deaths and more than 8,200 hospitalizations since Aug. 30, according to the Atlanta-based CDC. Frieden didn’t update the numbers of infected during today’s call. “We are currently in a situation where we have too little vaccine in the community,” Frieden said during a conference call with reporters. “It’s quite likely that too little vaccine is one of the things that’s making people more interested in getting vaccinated.” Health officials said last week the U.S. won’t get the 195 million doses it had planned for by the end of the year. Americans may get 42 million doses by mid-November, 8 million less than earlier U.S. estimates, said Nicole Lurie , Health and Human Services assistant secretary for preparedness and response, in an Oct. 23 telephone interview. Lurie linked the shortage to production delays. Greater Demand “When we have shortages we see an increase in demand,” Frieden said today. “In the next week or so, there will be a significant increase in the perceived and real availability of vaccine.” Frieden said medical authorities still recommend the vaccine be given first to people most at risk of severe infection from swine flu. Children and young adults ages 6 months to 24 years, pregnant women, those with underlying medical conditions and health-care workers are most at risk according to the CDC. ‘Many millions’ of H1N1 cases have occurred in the U.S. since the outbreak began in April, he said Oct. 23. “We wish we had better technology that could produce vaccine in weeks or months, rather than the six to nine months it takes with current, tried-and-true technology,” Frieden said. “It’s challenging with a limited amount of vaccine for a lot of people who want to get vaccinated.” Similar Symptoms While H1N1 produces similar symptoms and outcomes as seasonal flu in most cases, it targets a younger population and can lead to severe illness and death. The seasonal flu kills about 36,000 people a year in the U.S., though the majority of those deaths are in people over the age of 80. Ninety-five children have died from confirmed swine flu since April 2009, more than the pediatric toll for a typical year of influenza, the CDC said on its Web site, which tracks deaths from 28 states that provide data. To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net .

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Swine Vaccine Shortages Due to Drugmaker Delays, U.S. Official Reports

October 24, 2009

By Pat Wechsler Oct. 23 (Bloomberg) — Swine flu vaccine supplies in the U.S. are being hindered by production delays at two drugmakers, and GlaxoSmithKline Plc’s failure to gain regulatory approval for its product, a government official said. The U.S. won’t get the 195 million doses it had planned for by the end of the year because of the delays, said Nicole Lurie , Health and Human Services assistant secretary for preparedness and response. She said Americans may get 42 million doses by mid-November, or 8 million less than earlier U.S. estimates. Lurie didn’t identify the two companies with manufacturing delays. Besides Glaxo and AstraZeneca Plc , both based in London, Sanofi-Aventis SA of Paris, Novartis AG in Basel, Switzerland, and CSL Ltd. of Melbourne provide the bulk of the U.S. supply. “I now am hearing from CEOs that they are not where they thought they would be,” Lurie said in a telephone interview today. “Plus I keep hearing from them about all the problems the other companies are having.” Novartis Chief Executive Officer Daniel Vasella , in an interview on CNBC yesterday, said that most of his company’s vaccine may not reach the U.S. until the first quarter of 2010. The Swiss company is the largest supplier to the U.S. “The utility of the vaccine will be much less at that point,” said William Schaffner , chairman of the department of preventive medicine at Vanderbilt University in Nashville, Tennessee. “The virus will have gotten to most places before the vaccine” based on how rapidly it is now spreading in most of the country. Seasonal Flu Surge Schaffner said swine flu, while still circulating at that point, will be gradually replaced by a surge in seasonal flu. U.S. health officials started getting the bad news from producers around Columbus Day weekend, Lurie said. “In that week we heard from three producers, two in one day, that they were not going to hit their targets,” she said. “It has been an unbelievably frustrating situation for all of us.” “The problems they were having were taking much longer to fix than anticipated,” she said. Swine flu, also known as H1N1, is widespread in 46 states, the U.S. Centers for Disease Control and Prevention said today. Mortality rates have surpassed the threshold for an epidemic, the agency reported Oct. 16. Ninety-five children have died from confirmed swine flu, more than the pediatric toll for a typical year of influenza, the CDC said on its Web site , which tracks deaths from 28 states that provide data. Numbers Rising There were 411 confirmed swine-flu deaths in the 28 states reporting numbers and 2,416 probable from Aug. 30 to Oct. 17, according to the CDC. The agency reported 8,204 confirmed hospitalizations with a probable 21,823. The hospital data comes from 27 states reporting to the CDC. Geneva-based World Health Organization officials have said numbers reported worldwide for the flu, known as H1N1, are artificially low because countries have stopped testing to confirm the influenza. There were 16.1 million doses of the vaccine for swine flu as of Oct. 23, said Thomas Frieden , director of the Atlanta- based CDC. “Initially all the companies had problems with the low yields of vaccine from the eggs,” Lurie said. “One company was particularly slow to turn around that problem. Then they thought they fixed it and again they were overly optimistic.” Another company that Lurie declined to name introduced new production lines for vaccine, and then overestimated how fast it could deliver, she said. Manufacturers ‘Shocked’ “Some of the manufacturers never fully appreciated the impact of these delays,” Lurie said. “They are shocked by the havoc this can raise with the public and I think they will be a lot more conservative from now on.” Lurie said she had a friend who called her from Boston asking her to arrange vaccine for a pregnant woman she knows. “We don’t want it to get like that,” she said. “People don’t need to be panicked.” One “positive surprise” for public health officials was getting a larger than expected delivery of the nasal spray version of the vaccine, made by AstraZeneca’s MedImmune Inc. unit in Gaithersburg, Maryland, Lurie said. The U.S. has almost as much of the inhaled product as the injected kind, Frieden said. While providers often have unused nasal spray at the end of a typical flu season, he said that version of the vaccine is effective for people ages 2 to 49, he said. Timeline for Shots Vaccines take from six months to seven months to be developed, according to Vanderbilt’s Schaffner, who also serves as a liaison to the CDC’s advisory committee on vaccines and immunizations. “This was and continues to be an heroic effort,” he said. Glaxo is facing “challenges” because it primarily produces vaccine with an adjuvant, an ingredient added to vaccine to boost potency, Lurie said. U.S. health officials decided not to use an adjuvant in its immunization program, and Glaxo doesn’t yet have regulatory approval for the shot it produces without a booster. Now the U.S. expects only “a small amount of unadjuvanted vaccine at the end of the year,” from Glaxo, Lurie said. There’s a chance the U.S. won’t receive any, she said. “The enemy here is the virus,” Frieden said today at a conference call with reporters. “Manufacturers are working as quickly as possible to get the vaccine out safely.” Claire Brough , a Glaxo spokeswoman, said in an e-mail that her company “can’t confirm when we will begin shipping vaccine in the U.S. We are continuing to work with HHS to determine how we can best meet their needs and final shipping dates will not be known until those discussions, and the regulatory approval process, have been completed.” Sanofi Response Sanofi Chief Executive Officer Chris Viehbacher said his company is “the only manufacturer that will fulfill the U.S. commitments exactly. As of Monday, we’ve provided 16 million doses and committed to giving 75 million doses, as promised.” Any slowdown was because of “packaging and filling,” Viehbacher said today in a telephone interview. Sanofi is “now trying to package and fill both seasonal flu and H1N1” orders, he said. CSL was “on schedule” to delivery its 36 million doses, Sheila Burke , a spokeswoman, said. Eric Althoff , a spokesman for Novartis, said his company was delayed because the seed virus used to make the product yielded one-fifth of the vaccine that was expected. Seed Virus “We did switch to a new seed virus a couple of weeks ago, and the first signs are that it will have higher yields,” Althoff said. “We should have more volume toward the end of the year.” “We expect to have the bulk of the vaccine production completed before the end of the year, the raw form of the vaccine,” he said. “How much packaged material will be delivered before the end of the year is harder to predict. It might flow into January.” Novartis shifted 300 people from other businesses to vaccine production, an area that normally has about 2,500 workers, Althoff said. Lurie said the U.S. government has worked with the drugmakers to improve their output. The companies were instructed to switch from single-dose vials to multidose as a way to speed up the process, she said. “If we hadn’t done that we would be in a much worse place than we are now,” Lurie said. To contact the reporters on this story: Pat Wechsler in New York at pwechsler@bloomberg.net

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Code Green Networks Announces New Channel Director to Accelerate and Expand Partner Program

October 19, 2009

Empower Partners to Capture Rapidly Growing Data Loss Prevention Market Shares

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Swine Flu Vaccine Target for Coming Weeks Won’t Be Met, CDC Official Says

October 16, 2009

By Pat Wechsler and Tom Randall Oct. 16 (Bloomberg) — Swine flu vaccine production has been delayed, so monthly estimates won’t be met, U.S. health officials said. The delays will have “a substantial impact” on state schedules for inoculation as deaths rise above epidemic levels, Anne Schuchat , head of the National Center for Immunization and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention, said today on a conference call. There were 11.4 million doses available as of Oct. 14, 8 million of which had been ordered by states. Swine flu is now “widespread” in 41 states compared with 37 reported last week, and for the first time mortality rates have surpassed the threshold for an epidemic, she said. The first doses of swine flu vaccine reached U.S. doctors beginning Oct. 6. The country’s biggest influenza prevention program is aimed at curbing the earliest flu season in at least four decades. The U.S. has ordered more than 250 million doses from vaccine makers Sanofi-Aventis SA in Paris and AstraZeneca Plc in London. To contact the reporters on this story: Pat Wechsler in New York at pwechsler@bloomberg.net ; Tom Randall in New York at trandall6@bloomberg.net

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Tylenol Given to Kids After Vaccinations Lessens Effect of Shots in Study

October 15, 2009

By Marthe Fourcade Oct. 16 (Bloomberg) — Children who get Tylenol and other brands of the painkiller paracetamol after vaccination to avoid a high fever aren’t as well protected as those who don’t, a study found. Babies who took paracetamol, also known as acetaminophen, right after a shot had less fever but also showed a lower immune response, possibly because the drug reduced the inflammation that may favor interactions between immune cells, according to research published in the medical journal The Lancet . Using the painkiller, also sold under the brands Calpol in the U.K. and Anacin in the U.S., to prevent fever after vaccination “has become routine practice and is even recommended in some countries,” wrote the researchers, led by Roman Prymula of the University of Defence in Hradec Kralove , the Czech Republic. Prymula and his colleagues studied 459 healthy babies divided in two groups. One group received three doses of paracetamol after vaccination and the other didn’t. The researchers had two goals: to gauge how much fever the children had and how well immunized they were after the initial vaccine and the booster shot. The children were vaccinated against diphtheria, tetanus, poliomyelitis, hepatitis B, whooping cough, diarrhea-causing rotaviruses and Haemophilus influenzae type B, a bacterium that can cause pneumonia and meningitis. High Fever Forty-two percent of the children who got paracetamol after the first shot had a fever of 38 degrees Celsius (100.4 degrees Fahrenheit) or above, compared with 66 percent of those who didn’t, the study showed. High fever was rare in both groups. The immune response of the painkiller group, measured by the concentration of antibodies in their blood, was “significantly lower,” the researchers wrote. “Vaccine policy makers must now assess the implications for vaccinations programs,” Robert Chen and Thomas Clark from the Centers for Disease Control and Prevention in Atlanta and Scott Halperin from Dalhousie University in Halifax, Canada, wrote in a comment published by The Lancet with the study. “Prymula and colleagues present a compelling case against routine use of paracetamol during pediatric immunizations.” The vaccines used in the study were manufactured by London- based GlaxoSmithKline Plc , which funded the research. To contact the reporters on this story: Marthe Fourcade at mfourcade@bloomberg.net

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Napolitano Says Coordination is Key to Tracking Al-Qaeda Backers in U.S.

October 13, 2009

By Jeff Bliss and Justin Blum Oct. 13 (Bloomberg) — Authorities are tracking terrorists with al-Qaeda leanings in the U.S. by focusing on better sharing of information, Homeland Security Secretary Janet Napolitano said. “It is fair to say there are individuals in the United States who ascribe to al-Qaeda-type beliefs,” Napolitano said in an interview with Bloomberg Television yesterday. “And so it makes information-sharing, it makes effective law enforcement and it makes the shared responsibility of law enforcement ever so important.” Information-sharing between federal, state and local law- enforcement agencies is “much improved” since the Sept. 11 attacks, she said. Last month, U.S. authorities indicted Najibullah Zazi , 24, an Afghan immigrant and former Denver airport shuttle-van driver, on federal terrorism conspiracy charges. They said bomb-making instructions were found on a laptop computer in his rental car. U.S. Attorney General Eric Holder said the case had connections to al-Qaeda, the terrorist group that attacked the U.S. on Sept. 11, 2001. The threat of attack “is always with us,” Napolitano said yesterday. Benchmark stock indexes trimmed gains after her comments. Napolitano, 51, made her remarks in an interview with Bloomberg reporters. She touched on a variety of areas she oversees. Better Enforcement Intelligence tips on terror suspects are more important than a system to track visitors leaving the country, she said. She said better border enforcement will help make the case for immigration legislation. As one of the public officials leading the government response to swine flu, Napolitano compared public fears to getting a vaccine to past needless concerns over the government fluoridating drinking water. The secretary said she met yesterday with financial institutions on threats to computer systems. She said she also was in New York to appear on ABC’s “The View” and “The Daily Show with Jon Stewart ” on Viacom Inc. ’s Comedy Central, seeking different venues from which to discuss homeland- security issues. Successes against al-Qaeda have helped keep the main organization holed up in the tribal region of northwestern Pakistan, she said. “Constant pressure on al-Qaeda through a variety of means, some of which have been through the Department of Defense, has really confined them geographically,” she said. Tracing Finances Al-Qaeda leaders have been caught or killed, and the group’s financing has been traced and blocked, Napolitano said. The leaders are adapting to the U.S. tactics by using affiliated groups in northern Africa and other regions to help plan attacks, she said. “This is not a static target or a static threat environment,” she said. “We can’t simply say we can check this box and we can move on.” In the U.S., the government has put money into gathering intelligence about the movements of terrorist suspects, Napolitano said. “The key thing is intelligence analysts,” she said. This effort is more of a priority than developing a system that could keep track of visitors, she said. The government can’t track the more than 200,000 people who intentionally have overstayed their visas, the New York Times said yesterday. “Such a system would be very, very expensive and laborious to have, given the kinds of border we have,” she said. Scientists and engineers aren’t “even sure they have the technology to make it work.” Border Patrol In addition to improving intelligence, the U.S. is getting more control over its borders by adding Border Patrol agents and increasing enforcement, particularly in the Southwest, she said. Napolitano, who was governor of Arizona until President Barack Obama picked her for his Cabinet, said the stepped-up monitoring and rounding up of illegal border-crossers is quelling opposition to immigration legislation. “One of the things that has changed is that there has been a lot of enforcement at the Southwest border,” she said. “It’s just not the same border.” Republican lawmakers in 2007 helped defeat a comprehensive immigration measure pushed by former President George W. Bush’s administration over concerns about lack of enforcement. The Bush-backed measure included a program that allowed foreigners to temporarily work in the U.S. Napolitano declined to say when Congress would begin debate on another immigration measure. The Homeland Security department is working with Senator Charles Schumer , a New York Democrat, on the legislation, she said. Cyber-Security The secretary said her meeting with financial institutions yesterday was part of an effort to increase communication between the federal government and the private sector on boosting security of computer networks. “The financial institutions of this country are part of our bedrock infrastructure,” she said. “They need to be protected. We need to be able to protect them.” They discussed companies’ needs, barriers they are confronting and international threats, she said. Napolitano declined to name the people she met with, saying she didn’t have a list. The U.S. is concerned about the use of computer systems to commit fraud or interfere with infrastructure, she said. Computer Threats She said financial leaders want to receive “actionable intelligence.” Larger banks and brokerages have “a pretty robust information-sharing system amongst them” about cyber- security, she said. “We want to make sure that medium-, small-size local financial institutions are properly looped in and that they have a point of contact in the Department of Homeland Security either to report intrusions or prevent intrusions,” she said. On another issue, Napolitano said she expected many U.S. residents to be vaccinated against the swine flu, also known as H1N1, once the vaccine becomes widely available. The first doses of swine flu vaccine were given to health- care workers and children last week, and about 6.8 million doses are available to be shipped. This influenza strain and the seasonal flu require separate shots, which can be taken at the same time. The Atlanta-based Centers for Disease Control and Prevention said the swine flu is widespread in 37 states. The H1NI vaccine “is a very safe vaccine,” Napolitano said. “We can prevent a lot of illness and perhaps death, the more people we can vaccinate.” Getting Shots The secretary said she’s concerned about polls that show many Americans won’t be getting a swine flu shot. “This is something where getting the vaccine is so much the better” than not, she said. “We need to keep pumping out that information.” Three studies published yesterday found that the swine flu caused respiratory problems in otherwise-healthy young patients, a pattern similar to the 1918 flu that killed millions of people. Swine flu has killed about 4,500 people worldwide, including more than 600 in the U.S., the World Health Organization reported last week. To contact the reporters on this story: Jeff Bliss in Washington jbliss@bloomberg.net ; Justin Blum in Washington at jblum4@bloomberg.net

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Napolitano Says Terrorists With al-Qaeda Leanings Are Currently in U.S.

October 12, 2009

By Jonathan D. Salant Oct. 12 (Bloomberg) — Homeland Security Secretary Janet Napolitano said terrorists with al-Qaeda leanings are in the U.S. “It is fair to say there are individuals in the United States who ascribe to al-Qaeda-type beliefs,” Napolitano said in an interview with Bloomberg Television today. “And so it makes information-sharing, it makes effective law enforcement and it makes the shared responsibility of law enforcement ever so important.” Information-sharing between federal, state and local law- enforcement agencies is “much improved” since the Sept. 11 attacks, she said. In September, U.S. authorities indicted Najibullah Zazi, 24, an Afghan immigrant and former Denver airport shuttle-van driver, on federal terrorism conspiracy charges. They found bomb-making instructions on a laptop computer in his rental car. Attorney General Eric Holder said the case had connections to al-Qaeda, the terrorist group that attacked the U.S. on Sept. 11, 2001. The threat of attack “is always with us,” Napolitano said today. Benchmark stock indexes trimmed gains after her comments. Napolitano said she met in New York today with leaders in financial security in order to discuss ways to protect the nation’s financial system from cyber-terrorism or other attacks. “The financial institutions of this country are part of our bedrock infrastructure,” she said. “They need to be protected. We need to be able to protect them.” Swine Flu On another issue, Napolitano said she expected many U.S. residents to be vaccinated against the swine flu, also known as H1N1, once the vaccine becomes widely available. The first doses of swine flu vaccine were given to health- care workers and children last week, and about 6.8 million doses are available to be shipped. This influenza strain and the seasonal flu require separate shots, which can be taken at the same time. The Atlanta-based Centers for Disease Control and Prevention said the swine flu is widespread in 37 states. The H1NI vaccine “is a very safe vaccine,” Napolitano said. “We can prevent a lot of illness and perhaps death, the more people we can vaccinate.” Three studies published today found that the swine flu caused respiratory problems in otherwise-healthy young patients, a pattern similar to the 1918 flu that killed millions of people. Swine flu has killed about 4,500 people worldwide, including more than 600 in the U.S., the World Health Organization reported last week. To contact the reporter on this story: Jonathan D. Salant in Washington at jsalant@bloomberg.net .

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CVS, Walgreen Have Spot Shortages of Seasonal-Flu Vaccine on Demand Surge

October 10, 2009

By Carol Wolf and Tom Randall Oct. 10 (Bloomberg) — CVS Caremark Corp. and Walgreen Co., the two largest U.S. drugstore chains, are experiencing spot shortages of seasonal-flu vaccines because of increased demand. CVS MinuteClinics in Austin, Texas, and New York ran out of the seasonal-flu vaccine within the past week before restocking, according to calls to 13 stores by Bloomberg News. Calls to eight Walgreen stores in Manhattan on Oct. 5 determined none had it at the time. There are also shortages in the South and Southeast, said James Cohn , a Walgreen spokesman. Demand for seasonal-flu vaccinations has soared because of public awareness of the H1N1 virus, known as swine flu, Cohn said. Walgreen administered twice as many doses in September as in the entire 2008 flu season, he said. CVS’s clinics have vaccinated a “significantly higher number of people” than last year, said Michael DeAngelis , a spokesman. “We are experiencing very high demand for seasonal-flu shots and we are working closely with multiple suppliers to meet this demand on a day-to-day basis,” DeAngelis said in an e-mail yesterday. “When we experience isolated shortages of vaccine supply, we do all we can to replenish these locations.” Seasonal-flu vaccines don’t prevent swine flu, according to the Atlanta-based Centers for Disease Control and Prevention . The first doses of swine flu vaccine in the U.S. were given to health-care workers and children this week. Walgreen administered 2.5 million seasonal-flu vaccine doses last month, more than twice the 1.2 million it gave out from Oct. 1, 2008, through Feb. 28, Cohn said. Working With Suppliers “We are encouraging consumers to get vaccinated early,” Cohn said by telephone. CVS, based in Woonsocket, Rhode Island, rose 29 cents to $36.48 yesterday in New York Stock Exchange composite trading. Deerfield, Illinois-based Walgreen, the second-biggest drugstore chain, fell 19 cents to $39.45. Rite Aid Corp., the third- biggest, declined 4 cents to $1.56. CVS shares have gained 27 percent this year, compared with a gain of 60 percent for Walgreen and a more than fivefold jump for Camp Hill, Pennsylvania-based Rite Aid. While Rite Aid hasn’t had any seasonal-flu vaccine shortages, it also hasn’t yet received all its ordered doses, Cheryl Slavinsky , a company spokeswoman, said by telephone. Shortages at doctors’ offices and health clinics have also been reported in Arizona, Illinois, Minnesota, North and South Dakota and Vermont, according to the Web sites of local newspapers including the Addison County Independent in Vermont, the Grand Forks Herald of North Dakota and the Star Tribune in Minneapolis. A Few Weeks Behind Paris-based Sanofi-Aventis SA , a supplier of seasonal-flu vaccines in the U.S., said delays are causing shortages in some areas. Sanofi is “a few weeks” behind schedule, and has distributed more than 30 million of its allocated 50.5 million doses to the U.S., spokeswoman Donna Cary said. “Everyone wants their vaccine now,” Cary said by telephone. “Whether everybody is trying to get the vaccine early this year or if there’s truly an increase in demand has yet to be determined. “Every single customer that we have has gotten at least their initial shipment from us.” Five vaccine suppliers — Sanofi, London-based AstraZeneca Plc and GlaxoSmithKline Plc , Basel, Switzerland-based Novartis AG and CSL Ltd. of Australia — are making 114 million seasonal- flu doses and 251 million swine flu doses for the U.S., according to the Health and Human Services Department. More Vaccine Available “The good news is that we have more seasonal-flu vaccine out than we typically would this time of year,” Anne Schuchat , head of the National Center for Immunization and Respiratory Diseases at the CDC, said on a conference call yesterday. “The bad news is that more people want it than can seem to be able to get it.” More doses are being shipped, and over the next few weeks, there will be enough for everyone who wants to get vaccinated, she said. “We wish we had more vaccine for everybody who’s looking for it and for providers who are trying to get it,” said Schuchat. Some manufacturers have shifted their efforts to focus on making the swine flu vaccine available, Schuchat said. Almost all of the flu circulating in the U.S. is the pandemic H1N1 strain, the CDC reported on its Web site. Swine flu continued to sweep across the country last week, with widespread illness reported in 37 states, the CDC reported. About 4,500 people have died of swine flu since the virus emerged in April, the World Health Organization said yesterday. The first H1N1 vaccinations this week were administered as part of the world’s biggest influenza prevention program. About 6.8 million doses were available as of Oct. 8, the CDC said. To contact the reporters on this story: Carol Wolf in Washington at cwolf@bloomberg.net ; Tom Randall in New York at Trandall6@bloomberg.net .

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Deadly Virus Hunters Narrow Search for Ebola, Marburg Source to Fruit Bats

October 2, 2009

By Jason Gale Oct. 2 (Bloomberg) — Scientists are closing in on the source of Ebola and Marburg , two of the world’s most-lethal infectious diseases. After a five-year search in the jungles of Africa, an international team of virus hunters has identified a fruit bat that may be the natural host for both hemorrhage-causing diseases. Also, the viruses are more widespread than previously thought, according to their research , which was accepted this week for publication in the open-access journal BioMed Central . The study, based on blood tests on more than 2,000 bats in Gabon and the Republic of Congo, will help scientists solve a mystery that has confounded them for more than 30 years: which species harbor Ebola and Marburg without getting sick. The answer may explain how the viruses persist in the environment and point to ways humans can avoid a disease that causes fatal bleeding and organ failure in at least half of cases. “Very eminent scientists have been searching for decades to find the source,” said John Mackenzie , a Melbourne-based virologist who assists the World Health Organization in its response to outbreaks. “Until you know what it is, you can’t piece together the epidemiology or begin to think about managing the risks to both humans and wildlife.” Marburg hemorrhagic fever was recognized in 1967, when outbreaks occurred in laboratories in Marburg and Frankfurt, Germany, and in the Serbian capital, Belgrade. Cases were traced to African green monkeys imported for research and polio vaccine production. Nine years later, a closely related virus was found to have sparked a deadly outbreak near the Ebola River in the Democratic Republic of Congo, formerly known as Zaire. Caves and Mines Disease trackers have tested everything from snakes to guinea pigs in the search for an animal reservoir and have been repeatedly led back to caves, mines and bats. A 2005 study published in the journal Nature found evidence of symptomless Ebola infection in three species of fruit bat in West Africa, indicating that these animals may be the ones silently harboring the virus. In March, scientists reported the first evidence directly connecting a human Ebola outbreak to the putative fruit bat reservoir . The study reported this week is the first to show that Ebola and Marburg are circulating simultaneously in bat populations in one country. While several human Ebola outbreaks have occurred in Gabon, no cases of Marburg have been reported there, the authors said. The presence of Marburg virus in the West African nation represents a “potential and previously unrecognized threat to humans,” they said. Bats’ Blood “These findings provide much stronger evidence for a reservoir in bats,” Xavier Pourrut , a virologist at Gabon’s International Center for Medical Research in Franceville and the study’s lead author, said in a telephone interview. “The next step is to understand how the viruses circulate in bat populations over time.” Pourrut and collaborators from the Special Pathogens Branch of the Centers for Disease Control and Prevention in Atlanta and France’s Institute for Development Research looked for evidence of previous Ebola and Marburg infection in the blood samples of 2,147 bats from at least nine species. Tests were conducted from 2003 to 2008 in three regions of Gabon and in the Ebola epidemic region of north Congo. Of all the bats sampled in significant numbers, only specimens of the cave-roosting Egyptian fruit bat, or Rousettus aegyptiacus, were found to harbor antibodies against both Marburg and Ebola, the authors wrote, “suggesting that this species may be a natural host of both viruses.” Eating Apes The Egyptian rousette, with a doglike face and ears, is found along the Nile River in Egypt, across Sub-Saharan Africa, eastern Mediterranean and the Middle East. While some groups may occasionally roost outside in trees, the bats of this species prefer to inhabit caves, mines and tombs, and feast on fruit trees at night. These preferences give it a stronger link with the circulation of Marburg than Ebola, a virus more frequently found in rain forests, said Pierre Formenty , leader of the emerging and dangerous pathogens team at the WHO in Geneva. Formenty was among 29 authors of a study published in July that showed Marburg virus could be isolated from seemingly healthy Egyptian fruit bats caught in Uganda’s Kitaka Cave, where miners infected with the virus in 2007 had worked. While some outbreaks in humans have been directly linked to contact with bats, more evidence exists to link cases with infected apes, chimpanzees and other primates that are often consumed in Central Africa. These animals, in turn, probably got the virus by eating fruit contaminated with saliva or other bodily fluids from bats, according to Pourrut. Bleed to Death Once a human is infected, there is no cure for Ebola or Marburg. After an incubation period of about a week, victims rapidly develop high fever, diarrhea, vomiting, respiratory disorders and hemorrhaging. Death can ensue within a few days. About a quarter of Marburg cases are fatal, whereas case fatality rates range from 50 to 80 percent with Ebola in Africa. Ebola may circulate naturally within at least one other bat species and spread to members of the Egyptian rousette via contact with infected saliva left on fruit remnants, Formenty said in an interview. Also, no link with the Egyptian fruit bat was found with at least three Ebola outbreaks, he said. “We’ve got a whole lot of clues on the crossword puzzle and we’re just filling the blanks now,” said Bob Swanepoel , a virologist at South Africa’s National Institute for Communicable Diseases in Johannesburg, who first sought to unravel the history of Marburg in the mid-1970s. Scientists will complete the task within a decade, he said. To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net

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Flu May Trigger Heart Attacks Say Researchers Who Urge Greater Vaccination

September 22, 2009

By Michelle Fay Cortez Sept. 22 (Bloomberg) — The flu may trigger heart attacks and raise the risk of dying from heart disease, said researchers who analyzed data collected the past 75 years. A review of 39 studies conducted from 1932 to 2008 found consistent links between influenza and major heart attacks, bolstering previous observations that the heart can be damaged in patients with influenza, according to the report in Lancet Infectious Diseases . People at risk for heart attacks, including those with diabetes and cardiovascular disease, should get vaccinated against influenza, said the researchers led by Andrew Hayward from University College London’s Center for Infectious Disease Epidemiology . While the immunization is recommended for people with chronic conditions, fewer than half of them in the U.K. were vaccinated last year, the researchers said. There is “consistent evidence” that influenza triggers acute heart attacks and death from cardiovascular disease, the researchers concluded. There is also some evidence that influenza vaccines may reduce the danger, particularly in patients with existing heart disease, they said. The number of people expected to develop the flu is higher than normal this year as a novel swine flu circles the globe. Rising Cases The pandemic has spiked over the last two weeks in the U.S. and U.K. as students returned to tightly packed classrooms. Health officials are racing to begin vaccination campaigns to curtail the outbreak, which in the U.S. is already higher than the peak rate in two of the last three flu seasons, according to the Atlanta-based Centers for Disease Control and Prevention . Influenza may increase levels of inflammation in the body, raising the risk that fatty plaque in the arteries breaks off to form a heart attack-causing clot, the researchers said. “We believe that influenza vaccination should be encouraged wherever indicated, especially in people with existing cardiovascular disease,” the researchers said. More evidence is needed to determine the effectiveness of vaccines to reduce heart risks in patients without existing disease, they said. To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net

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