virus

Insomnia Costs America $63 Billion A Year: Study

by Simon McCormack on September 1, 2011

Huffington Post…

A new study finds that nearly a quarter of American workers experience some form of insomnia, and the disorder is costing the country billions of dollars in lost productivity. Health.com notes that the study , conducted by researchers at Harvard Medical School, surveyed 7,428 employed workers across the country. They discovered that 23 percent had insomnia-related problems, including difficulty falling asleep or nighttime waking, at least three times a week during the previous month. The study also found that insomniacs were so tired during work that they cost their employers about eight days of work per year. That translates to about $2,280 per person. If you expand those results to the entire country, the study found that insomnia costs the U.S. economy about $63 billion annually. Given these results, the study’s researchers say employers may want to implement screening policies for insomnia, similar to the ones already in place for other medical conditions, according to All Headlines. “Now that we know how much insomnia costs the American workplace, the question for employers is whether the price of intervention is worthwhile,” study author Dr. Ronald C. Kessler told CBS. “Can U.S. employers afford not to address insomnia in the workplace?” RELATED VIDEO:

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Europe Gets 179 Million H1N1 Shots, Uses at Least 20%

by on June 4, 2010

By Jason Gale June 4 (Bloomberg) — GlaxoSmithKline Plc , Novartis AG and Baxter International Inc. distributed more than 179 million doses of pandemic flu vaccine in Western Europe, of which at least a fifth has been used, the European Medicines Agency said. Glaxo was the biggest supplier to the European Economic Area , distributing at least 131.7 million doses of its shot through May 31, the EMA said in a report yesterday. The agency estimated that at least 30.7 million patients were immunized with the London-based company’s vaccine, Pandemrix. Safety concerns and a lower-than-expected death rate from the virus, also known as swine flu, damped demand for vaccine in some European countries. The EMA report, which summarizes adverse reactions to pharmaceuticals used in response to the new H1N1 flu strain, said the “vast majority” of side effects weren’t serious and the 2,900 reported H1N1-related deaths in Europe were only a proportion of the region’s actual fatalities. “The benefit-risk balance of the centrally authorized pandemic vaccines and antivirals for the current H1N1 influenza pandemic continues to be positive,” the EMA report said. At least 36 million doses of Novartis’s Focetria pandemic flu vaccine have been distributed in the European Economic Area, the London-based EMA said, citing data available on April 17 from member states and the Basel, Switzerland-based company. At least 6.5 million patients received the shot in the region, which comprises mostly Western European nations. Baxter, based in Deerfield, Illinois, distributed at least 11.7 million doses as at May 17, the EMA said, citing information provided by the company and member states. The agency said at least 566,000 people received the immunization, known as Celvapan. To contact the reporter on this story: Jason Gale at j.gale@bloomberg.net

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theGrio: Tainted Meat Exposes US Consumers to HIV-like Virus

May 27, 2010

This post originally appeared at theGrio.com By Jennifer H. Cunningham Primate parts smuggled inside cases of fish. Suitcases stuffed with dried duiker antelope that’s later sold door to door. Smoked cane rat strapped under a smuggler’s clothes. These are the hallmarks of the unregulated, underground bushmeat trade in America. The high demand for this meat among certain African communities is jeopardizing public health here, destroying the lives of those who depend on the forest to survive, and endangering both the environment and an already vulnerable species, scientists and wildlife advocates say. “There is no doubt that thousands of pounds of bushmeat is coming into the country every month,” said Dr. Heather E. Eves, former director of the Bushmeat Crisis Task Force . Bushmeat, or meat from wild animals such as elephant, bat or chimpanzee, is a prized foodstuff in some African cultures — eaten on holidays and celebrations and believed to have medicinal benefits — according to according to Dr. Richard Ruggiero, branch chief of Near East, South Asia and Africa for the U.S. Fish and Wildlife Service Division of International Conservation. Some also believe consuming bushmeat will make them stronger, or even increase sexual prowess. Dr. Eves — now the visiting assistant professor at Virginia Tech’s Northern Virginia Natural Resources Program and professorial lecturer at Johns Hopkins School of Advanced International Studies — said bushmeat consumption is culturally significant, like the way turkey is for Americans on Thanksgiving. Dr. Ruggiero likened it to his family, who are from the Mediterranean, eating seafood for dinner on Christmas Eve. “You’re not doing it intending to be evil,” Dr. Ruggiero said. “You’re doing it because it’s your tradition. It’s understandable, and in some cases justifiable, but that doesn’t make it any better for the earth.” Bushmeat also serves as both a source of income and protein for those who harvest it, Dr. Eves said. Some types of bushmeat can be as expensive as filet mignon. “It’s a link to their culture,” Dr. Eves said. “That’s a very important piece. It can’t be replaced by any other types of food here.” But scientists believe bushmeat can harbor diseases that can spread from animal to human. The Centers for Disease Control, for example, says humans can contract a host of diseases from primates, including the Ebola virus, monkeypox, tuberculosis and yellow fever. Last month, the CDC and the Wildlife Conservation Society released preliminary test results that found primate bushmeat seized in New York City contained two strains of the simian foamy virus — a virus related to HIV — that can infect people. The related Simian Immunodeficiency Virus or SIV, has been found in bushmeat tested outside the country, and some believe that virus is responsible for the first HIV cases , according to the Wall Street Journal. “The movement and mixing of humans, wildlife, and domestic animals as part of the illegal global wildlife trade encourages transmission of disease and emergence of novel pathogens,” Dr. William Karesh, of the Wildlife Conservation Society’s Global Health Program, said in a statement. Nonetheless, the bushmeat trade is thriving in various U.S. locales, including Atlanta, Detroit, Washington, D.C. and New York. New Jersey is a particular hotspot for the trade, Dr. Eves said. “The availability of bushmeat in the U.S. is surprising,” she said. With expanded infrastructure into previously impenetrable forests, the process of transporting wild animals from the jungle to the dinner table takes only a few days. The hunter then prepares the meat for shipment, usually by charring off its fur, removing its organs and placing on a frame over an open fire to dry and smoke for a few days, Dr. Eves said. However, some meat is simply shipped raw. Dr. Eves recalled an airport in Central Africa where workers wrapped all suitcases in plastic after passengers complained their bags were getting blood on them. One problem in stemming the tons of bushmeat arriving in the U.S. every year is there aren’t enough inspectors to detect it. Bob Onda, supervisory inspector for the U.S. Fish and Wildlife Office of Law Enforcement, port of New York, is the first line of defense the U.S. has in keeping bushmeat out of the country. He and his staff of 12 investigators simply can’t inspect every parcel or person that arrives in New York. He said his team already inspects roughly 35,000 to 40,000 commercial shipments each year. Onda said the number of bushmeat seizures in the port of New York had declined, but said the bushmeat could be being smuggled in other ways, like in smaller shipments or to other cities. When caught, Onda said smugglers are “prosecuted to the fullest extent of the law.” Late last year, a New York Federal Court sentenced Mamie Manneh, a Liberian woman from Staten Island, to a three years probation for smuggling and selling smoked bushmeat, including primate parts. Next month, the Senate is expected to introduce the Global Conservation Act , which would create an international strategy to combat natural resource depletion worldwide, including the illegal bushmeat trade. Before globalized trade stretched to previously remote areas in Africa, those who lived there hunted bushmeat to eat and sell locally. But worldwide demand has created an insatiable and unsustainable need for bushmeat, leaving swathes of forest, or “bush,” bereft of wildlife and rendering many Africans unable to continue living a traditional lifestyle, Ruggiero said. Once the animals are gone, villagers who relied on bushmeat to survive are left virtually destitute and unable to maintain their way of life for themselves or for future generations. For example, some members of the Pygmy and Bantu tribes have been forced to work for the very logging camps that created the roads that brought the bushmeat hunters to their doorsteps, Ruggiero said. “They go down with the forest and the wildlife,” Ruggiero said. The bushmeat trade “is not just a biodiversity issue, it’s a human right’s issue.” He called on those in the U.S. to stop eating bushmeat, not only because of public health and environmental concerns, but because the trade destroying the lives of those who rely on the bush. “Understand that you are contributing to the compromise, death and destruction of the forest and the people who live in it,” he said. Related articles by Zemanta Ancient origin for monkey version of HIV (nature.com) Rare animals are being ‘eaten to extinction’ (telegraph.co.uk)

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Gonorrhea May Become Untreatable as Antibiotics Efficacy Wanes, WHO Says

April 29, 2010

By Simeon Bennett April 29 (Bloomberg) — Gonorrhea may become untreatable as the improper use of antibiotics reduces their ability to clear the sexually transmitted infection, the World Health Organization said. There is now “widespread resistance” to cheaper first- line antibiotics against the bacterium that causes gonorrhea, the WHO’s Western Pacific regional office said in a statement today. The agency said Australia, Hong Kong and Japan have reported treatment failures with cephalosporin, a class of antibiotics that’s the last line of defense against the disease. “We are dealing with a serious issue with the implication that gonorrhea may become untreatable,” Shin Young-soo , the WHO’s regional director for the Western Pacific, said in the statement. “This will have a major impact on our efforts to control the disease and will result in an increase in serious health-related complications,” Shin said. The WHO and U.S. Centers for Disease Control and Prevention have developed an action plan to improve monitoring for drug- resistant gonorrhea and identify alternative treatments against the disease, the Geneva-based agency said. Left untreated, gonorrhea can result in infertility, pelvic inflammatory disease, ectopic pregnancy, infections in newborn children and swelling of the scrotum, the WHO said. It also increases the likelihood of acquiring and transmitting HIV, the virus that causes AIDS. To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@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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Swine Flu Protection Added to Seasonal Flu Vaccine (Update1)

February 22, 2010

By Tom Randall Feb. 22 (Bloomberg) — Protection against swine flu will be added to the 2010-2011 seasonal influenza vaccine, putting an end to separate shots deployed against the pandemic, according to a U.S. Food and Drug Administration advisory committee. The pandemic H1N1 flu should replace the H1N1 strain from last year’s vaccine, the panel said today in a unanimous vote. Each year the three most commonly circulating strains are selected to be included in the shot. The panel’s recommendations are routinely adopted and used to guide vaccine manufacturers. The decision, which follows a similar recommendation by the World Health Organization in Geneva last week, may mean the end of the separate pandemic flu shots that London-based GlaxoSmithKline Plc , Novartis AG , based in Basel, Switzerland, and Paris-based Sanofi-Aventis SA have been selling since September. The previous strain of H1N1 “most likely poses a low risk in the forthcoming Northern Hemisphere season,” Nancy Cox, director of the flu division at the U.S. Centers for Disease Control and Prevention, said today at the panel hearing. The new strain of H1N1 will be added because it spreads easily in a population that had little immunity to it before this year, she said. Companies typically receive U.S. government advice on the flu shot’s composition in February so they can begin the manufacturing process months before the next flu season. The U.S. season lasts from November to March, according to the Atlanta-based CDC. The WHO recommended in September that the pandemic strain of the virus be included in the seasonal flu shot to be given in the Southern Hemisphere in 2010. Almost one in five Americans was infected by swine flu since the virus emerged in April, the CDC reported on Feb. 12. Ninety percent of the people who died were younger than age 65, the reverse of a typical flu season. About 12,000 Americans have died, compared with about 36,000 in an average season, when circulating strains attack the vulnerable elderly. To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net

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Swine Flu May Have Infected Every Second Schoolchild in U.S., Study Finds

February 22, 2010

By Jason Gale Feb. 22 (Bloomberg) — Swine flu may have infected at least 63 million people in the U.S. last year, according to a study in Pittsburgh, where almost every second schoolchild probably caught the pandemic virus. Blood tests on Pittsburgh residents found 45 percent of people aged 10 to 19 years had antibodies against the new H1N1 flu strain . About 22 percent of people across all groups developed immunity to the virus by early December and a quarter of those born in the 1920s may have already had protective antibodies before the pandemic resulting from prior flu infection, researchers at the University of Pittsburgh found. The findings, reported online yesterday in the Public Library of Science , suggest a fresh wave of swine flu infections isn’t likely unless the virus mutates or people become more susceptible to infection. A World Health Organization advisory panel is holding a teleconference tomorrow to discuss whether the first influenza pandemic in 41 years has peaked. “With current estimates of seroprevalence and continued increases in population due to vaccination, a significant change in viral antigens or a change in population immunity would be required for further disease spread,” Ted Ross, associate professor of microbiology at the university, and colleagues wrote. “We cannot rule out the possibility that geographical pockets of limited immunity may be present in which a third wave may yet occur.” Symptom-Free Cases At least 15,921 people have died from swine flu as the fast-moving pandemic spread to 212 countries and territories since its discovery in North America in April, the WHO said in a Feb. 19 statement . The global tally underestimates the actual number as many deaths are never tested or recognized as influenza related, the Geneva-based agency said. In yesterday’s study, researchers looked for infection- fighting antibodies against the 2009 pandemic flu strain in 846 anonymous blood samples collected in November and early December from people in southwestern Pennsylvania’s Allegheny County ages 1 month to 90 years. The tests identified people who caught the virus, including those who didn’t develop a fever, cough or other flu-like symptoms. The researchers compared the results against tests on blood samples collected in 2008, of which 6 percent contained antibodies that protected against swine flu, probably as a result of infection from a related influenza strain. Children and adolescents in the 10- to 19-year age group had the highest prevalence of swine flu antibodies, while 29 percent of blood samples from children younger than 9 years tested positive. Residents in the 70- to 79-year age group had the lowest prevalence rate of 5 percent. When the researchers extrapolated their findings across the county’s 1.2 million residents, they found swine flu antibodies in 21.5 percent of people, including more than 70,000 school-age children. “Extrapolating these results further to the entire US population, we estimate that 63 million persons became infected in 2009,” the authors wrote. To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net

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Aggressive Testing, Treatment Cuts HIV Spread in San Francisco, Study Says

February 17, 2010

By Rob Waters Feb. 17 (Bloomberg) — A public health effort to test people to find who might have HIV , the virus that causes AIDS, and to treat those infected has cut the rate of new infections in San Francisco, researchers said. A similar effort in Washington D.C. — where 3 percent of city residents are estimated to be infected, the highest rate of in the country — has also led to earlier diagnosis and treatment of people with the virus, according to scientists at an infectious disease meeting. Research has not yet determined whether this program has reduced the number of new infections. The San Francisco initiative lowered the percentage of infected people who are unaware they had HIV to 14.5 percent in 2008 from 24 percent in 2004 and boosted to 90 percent the portion of HIV patients who are taking antiviral medications, researchers from the University of California, San Francisco reported today at a medical meeting in San Francisco. The number of people diagnosed with HIV and reported to health authorities fell to 434 in 2008 from 798 in 2004. Findings from the two cities were presented today at the Conference on Retroviruses and Opportunistic Infections in San Francisco. To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .

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Glaxo Ends Depression Research, Begins Developing Rare-Disease Treatments

February 5, 2010

By Trista Kelley Feb. 4 (Bloomberg) — GlaxoSmithKline Plc will halt research into drugs for depression and pain and begin making treatments for rare diseases as the U.K. company tries to squeeze more products out of its laboratories. Glaxo will also focus on discovering new medicines for Alzheimer’s and Parkinson’s diseases and multiple sclerosis, the London-based company said today in a statement. Chief Executive Officer Andrew Witty said an expanded cost-savings program would bring job cuts affecting “hundreds rather than thousands” of positions in the U.K. Britain’s biggest drugmaker is seeking new products to keep sales rising after revenue from swine flu vaccine falls and older medicines lose patent protection. Fourth-quarter sales surged 17 percent, helped by sales of H1N1 flu vaccine, Glaxo said today. Glaxo is trying to weed out compounds from its 3.95 billion pound ($6.25 billion) research budget that are expensive to develop and provide little return on investment, Witty said. “This really all revolves around realities about doing research in this field,” Witty said of depression and pain projects on a conference call with reporters. Developing a drug that’s significantly better than existing medications is difficult and “they’re very expensive trials. That’s what drove the decision.” Orphan Status Treatments aimed at rare diseases can get so-called orphan status from regulators, giving the medicines a speedier review and up to seven years of market exclusivity in the U.S. and making them more attractive to develop. Moncef Slaoui , Glaxo’s head of research, told Bloomberg News in September that the company planned a move into orphan medicines. “If you want to save money in R&D, that’s a sensible area to go,” Jeffrey Holford , an analyst at Jefferies International Ltd., said in an interview. “Depression hasn’t delivered very many great medicines in the recent past for anyone full stop.” Orphan drugs “are a very profitable area.” Paxil, a Glaxo antidepressant that’s already on the market, has proved costly. The drugmaker has paid almost $1 billion to resolve lawsuits for over the drug since it was introduced in 1993, including about $390 million for suicides or attempted suicides, according to court records and people familiar with the cases. The drug brought in 513 million pounds of sales last year. Witty said fewer than 10 percent of rare diseases have treatments. Glaxo in October agreed to pay as much as 460 million euros ($637 million) to develop drugs from closely held Dutch biotechnology company Prosensa aiming to treat Duchenne muscular dystrophy. Savings Plan Profit excluding some items gained to 35.4 pence a share in the quarter, beating the 33.5 pence average estimate of 16 analysts surveyed by Bloomberg. Net income was 1.63 billion pounds, compared with 982 million pounds a year ago, Glaxo said in the statement. Sales rose to 8.09 billion pounds. Glaxo plans to add 500 million pounds of savings by 2012. The previous plan was to save 1.7 billion pounds a year by 2011. New products generated 1.3 billion pounds of sales in 2009, 15 percent more than the previous year. Generic copies of Glaxo medicines hurt U.S. sales by 1.4 billion pounds. “The problem for this company in terms of R&D has been that the revenue line is so big that they need to have an equally big portfolio of drugs coming through the pipeline to fill the holes,” Holford said. “Now that their patent drag is starting to ease off and it’s a more steady state then the pipeline can start to become more meaningful.” Shares Rise Glaxo shares gained 9 pence, or 0.7 percent, to close at 1,226 pence in London. The stock has fallen 3.3 percent in the past year, compared with a 13 percent rise in the Bloomberg Europe Pharmaceutical Index . Germany and France were among the European countries to slash orders for the drugmaker’s swine flu vaccine after the virus was milder than predicted. The shot brought in 835 million pounds for Glaxo in the fourth quarter, below the 1 billion pounds in sales expected by Credit Suisse analyst Luisa Hector before the cancellations. Sales of the vaccine helped offset revenue lost to generic copies of antiviral drug Valtrex, which hit the market in November. Valtrex revenue dropped 8 percent to 1.3 billion pounds in 2009. “We remain concerned about the 2010 order book” for the swine flu vaccine, Hector and colleagues wrote in a Jan. 27 note to clients. Earnings in 2010 will be “flat at best,” hurt by the loss of the flu windfall and by a faster-than-expected sales decline for Valtrex after the patent expiry, they wrote. Emerging Economies Since taking over the top job two years ago, Witty has stepped up expansion in consumer goods and emerging economies, making dozens of small acquisitions and licensing ventures in 2009. He repeated his strategy to stick with smaller, “bolt-on” acquisitions “only if we can find deals with clear financial hurdles,” he said. “We’ll have to see.” Glaxo’s earnings per share exclude restructuring charges related to what it calls “significant” acquisitions and costs from the savings program, which started in October 2007. To contact the reporter on this story: Trista Kelley in London at tkelley2@bloomberg.net

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Drug-Resistant HIV Wave Threatens Decades of AIDS Progress, Study Says

January 15, 2010

By Simeon Bennett Jan. 14 (Bloomberg) — A wave of drug-resistant HIV emerging in the U.S. threatens to undermine progress made in treating patients in poor countries, a study published online by the journal Science found. About 60 percent of drug-resistant HIV strains circulating in San Francisco can spur self-sustaining epidemics as patients who haven’t been treated spread them, researchers from the University of California, Los Angeles said in the study. About 75 percent of those strains are impervious to a class of drugs that includes those made by Pfizer Inc. , Johnson & Johnson and Bristol-Myers Squibb Co., they said. The mutant strains may reverse progress made in expanding treatment programs in poorer nations such as South Africa, where there is little access to back-up medicines when resistance occurs, researchers led by Sally Blower at the university’s Center for Biomedical Modeling said. Patients in developed countries are less likely to suffer because they have better access to alternative treatments, they said. “If the resistant strains we have identified in our analyses evolve in these countries, they could significantly compromise HIV treatment programs,” Blower and colleagues wrote. Mutant forms circulating in San Francisco and other rich cities “pose a great and immediate threat to global public health,” they said. The study casts doubt on research by World Health Organization experts published last year that predicted testing everyone for HIV in hard-hit African countries and treating all infections immediately may eliminate most of the virus’s spread. That model is flawed because it doesn’t take drug resistance into account, Blower said in a telephone interview. ‘Very Strong’ “Our modeling is saying the drug resistant strains that you will generate from this kind of strategy are ones that will be very strong, transmissible, and therefore you will get an awful lot of problems,” she said. About 33.4 million people were infected with the AIDS- causing virus worldwide as of the end of 2008, according to the WHO, making it the world’s most prevalent infectious disease. About 13 percent of people newly infected with HIV in San Francisco get drug-resistant strains, Blower and colleagues said in the study today. The extent of HIV drug resistance in developing nations hasn’t been measured because of a lack of reliable data , the WHO said on its Web site. Blower and colleagues developed a computer model to trace and predict resistance to three classes of HIV drugs known as PIs, NRTIs, and NNRTIs in San Francisco. The greatest resistance was to NNRTIs, a category that includes Bristol- Myers’ Sustiva, Johnson & Johnson’s Intelence and Pfizer’s Rescriptor. Similar trends have been observed in other cities in the U.S. and Europe, the authors wrote. The model predicted that resistance to NRTIs, such as Gilead Sciences Inc.’s Truvada, and PIs including Abbott Laboratories’ Kaletra will remain at current levels until 2013, while resistance to NNRTIs will increase. To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@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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Hilary Kramer: Don’t Underestimate the Impact of H1N1

January 4, 2010

For the American economy, this holiday season meant two things: shopping and travel. The financial ramifications of shopping are clear enough: companies hoped consumers would spend a lot; consumers hoped to get good deals and to spend within their budgets. Holiday travel would seem to follow the same dynamics. Except during these final days of the holiday season and as we begin the New Year, air travel has added a few more concerns into the business equation: exceedingly heightened security, inconvenience and health risks. The health concern is of particular importance because of H1N1, previously known as the “swine flu.” Holiday and vacation travel already occurs during the flu season, but what makes H1N1 especially worrisome is that as a new virus, most people have little or no immunity to it. This may explain why the disease has spread rapidly even among young people (ages 10 to 45). The Center for Disease Control estimates that between April and mid-October, between 14 million and 43 million people had the H1N1 flu. Even with the announcements of declining cases and pandemic fears waning, H1N1 is the type of virus that shouldn’t be considered yesterday’s concern. It’s not just the spread of the virus that’s attracted attention, but it’s that the impact on those infected with the virus has been severe. The Center for Disease Control estimates that the H1N1 virus has been responsible for the death of 10,000 Americans, with an additional 200,000 Americans being hospitalized since the CDC starting tracking the disease in March. Dr. Anthony Fiore, medical epidemiologist for the Influenza Division of the CDC, adds, “It’s clear that the 2009 H1N1 influenza pandemic has already had a major impact on health in the United States.” But what impact will H1N1 have on the nation’s economy? Overall, probably not that much. However, individual industries and companies will certainly be affected by it. Airlines and hotels already took their hit from H1N1 when it initially spread (though that impact was easily buried in the larger hit taken by those industries because of the financial crisis). And what will happen when the next form of influenza virus surfaces and begins to infect our communities? How quickly can we react, test and treat those affected? The H1N1 virus has even had an impact on the sports and entertainment industry. The National Football League team, St. Louis Rams, recently had to cancel practice because team officials were concerned that several players might have been infected with the H1N1 flu. There are some industries, though, that have benefited and will continue to benefit from H1N1. Pharmaceutical companies, for example, will experience some positive impact, as they develop and produce vaccinations that people seek to prevent catching the virus. The large drug manufacturers seem poised to be the main beneficiaries. The U.S. awarded Swiss pharmaceutical company Novartis nearly $500 million in contracts to build an H1N1 vaccine production facility in North Carolina. French drug manufacturer Sanofi-Aventis received an initial order of $190 million from the U.S. Department of Health and Human Services to produce the vaccine (though the company suffered an embarrassing recall of 800,000 doses of their vaccine in mid-December). Medical device companies might benefit as well. Today, patients are treated on the assumption of pandemic infection, only receiving an official diagnosis after days of waiting for laboratory results. Such an approach is neither cost nor time effective. PositiveID Corporation (NASDAQ: PSID) is a company developing a solution. The company’s point-of-care virus detection system for the H1N1 virus could allow caregivers to administer more efficient treatment based on an instant diagnosis. PositiveID’s system will not only target H1N1 but will be able to be adapted to specifically identify and diagnose new strains of flu and other pandemic viruses, which may enable the health care community to more effectively manage future outbreaks. The St. Louis Rams could certainly have benefited from such a device. Right now, there are only two types of tests available for H1N1: a polymerase chain reaction (PCR) test or a culture approach, neither of which is quick or inexpensive. The quick tests that are currently available are ones that only tell you whether or not you have the regular flu. So without really knowing if the several players with flu-like symptoms were actually infected with the H1N1 flu, team officials (wisely) just had to assume the worst and cancel practice. They couldn’t risk the possibility that the players were indeed infected with the H1N1 flu and might spread it to the rest of the team. With a device like the one PositiveID is developing, they wouldn’t have had to guess. That’s the beauty of the American economy. It turns problems into new solutions. Crises are transformed into opportunities. And the companies in the economy that are best poised to capitalize are the innovators, the ones able to respond the most efficiently, with the best research and development, and with the highest quality products. All with the objective of giving the American consumer the ability to live, work and play with the level of convenience, health and safety that we’ve grown accustomed to. So, in the early days of this New Year, shop on, America. And travel safe. Just make sure you’ve gotten your flu vaccinations beforehand.

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Quest for Elusive Obesity Pill May Yield Shionogi a Win Where Merck Failed

December 23, 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 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, today said it submitted an application to the FDA for its obesity drug lorcaserin. Vivus plans to request FDA clearance for its treatment Qnexa this month. 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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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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Swine Flu, Seasonal Flu Death Rates Aren’t Comparable, WHO Report Says

December 4, 2009

By Jason Gale Dec. 4 (Bloomberg) — The World Health Organization, facing criticism that it exaggerated the threat of swine flu, said it’s too soon to decide whether the pandemic is more or less deadly than seasonal flu and comparing death rates may be misleading. Mortality from the new H1N1 strain is “unquestionably higher” than the death toll reported by national authorities, the Geneva-based agency said in a report seen by Bloomberg News before its scheduled publication today. Deaths totaled more than 7,820 as of Nov. 22, said WHO, which estimates as many as 500,000 people die each year from seasonal strains. Health authorities worldwide are assessing whether their response to swine flu is justified by its threat as cases of flu-like illness retreat in the U.S. and U.K. While a majority of patients recover within days and reported fatalities are a fraction of the seasonal flu toll, these figures mask the full impact of swine flu on society, WHO said. “Compared with seasonal influenza, the H1N1 virus affects a much younger age group in all categories — those most frequently infected, hospitalized, requiring intensive care, and dying,” WHO said in the report. In Australia, about 3,000 people aged 50 or older die from seasonal flu each year, according to statistical modeling . Officials counted 190 deaths associated with confirmed swine flu, Jim Bishop, the nation’s chief medical officer, said last week in a report in the New England Journal of Medicine. Younger Victims The median age of patients who died was 53 years, compared with 83 year in seasonal epidemics, and the number of patients treated in intensive care units for viral pneumonia was about 14 times greater than normal, Bishop said in a telephone interview from Canberra today. “It’s a different type of virus affecting younger people and putting more people into hospital and ICU,” he said. “It’s not attacking older people in nursing homes.” Bishop said WHO’s decision to declare swine flu a pandemic in June helped guide the nation’s response, which he said was “proportionate and relevant.” The United Nations agency moved to the top level of its pandemic alert following advice from a group of scientists and health officials who may have ties to the pharmaceutical industry, Sweden’s Svenska Dagbladet newspaper said last week, citing reports in Danish newspaper Information and Science magazine. WHO spokesman Gregory Hartl told the newspaper that the decision to declare a pandemic was made by Director General Margaret Chan alone. ‘Machine Grinding’ In July, epidemiologist Tom Jefferson told Germany’s Der Spiegel that WHO, public health officials, virologists and pharmaceutical companies may have had ulterior motives in promoting the pandemic threat. “They’ve built this machine around the impending pandemic,” Jefferson was quoted as saying. “There’s a lot of money involved, and influence, and careers, and entire institutions,” he said. “All it took was one of these influenza viruses to mutate to start the machine grinding.” Public perceptions about the pandemic and national preparedness plans have been influenced since 2004 by the threat of bird flu, “widely regarded as the virus most likely to ignite the next influenza pandemic,” WHO said in a statement yesterday. The H5N1 strain of avian influenza killed 59 percent of the 444 people known to have been infected, according to WHO. Ulterior Motives “Adjusting public perceptions to suit a far less lethal virus has been problematic,” WHO said. “Given the discrepancy between what was expected and what has happened, a search for ulterior motives on the part of WHO and its scientific advisers is understandable, though without justification.” Since April, at least 622,482 people have been infected with the virus in more than 207 countries and territories, according to WHO. Swine flu infections and deaths reported to WHO are based on laboratory confirmed tests rather than mathematical modeling used to estimate fatalities from seasonal flu, the agency said. “With the current pandemic, we really have data which is almost an anomaly, when we look at how influenza has been counted in the past,” Keiji Fukuda , WHO’s special adviser on pandemic influenza, told reporters on a conference call from London yesterday. “People do not typically count influenza deaths on a one-by-one basis. And so, we do not have a lot of data on laboratory-confirmed deaths for seasonal influenza.” Accurate assessments of deaths and mortality rates will probably be possible only one to two years after the pandemic has peaked, WHO said. To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net

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Australian Scientist Repeats Swine Flu Lab-Escape Claim in Published Study

November 24, 2009

By Simeon Bennett Nov. 24 (Bloomberg) — Adrian Gibbs , the virologist who said in May that swine flu may have escaped from a laboratory, published his findings today, renewing discussion about the origins of the pandemic virus. The new H1N1 strain , which was discovered in Mexico and the U.S. in April, may be the product of three strains from three continents that swapped genes in a lab or a vaccine-making plant, Gibbs, and fellow Australian scientists wrote in Virology Journal . The authors analyzed the genetic makeup of the virus and found its origin could be more simply explained by human involvement than a coincidence of nature. Their study, published in a free, online journal reviewed by other scientists, follows debate among researchers six months ago, when Gibbs asked the World Health Organization to consider the hypothesis. After reviewing Gibbs’ initial three-page paper, WHO and other organizations concluded the pandemic strain was a naturally occurring virus and not laboratory-derived. “It is important that the source of the new virus be found if we wish to avoid future pandemics rather than just trying to minimize the consequences after they have emerged,” Gibbs and colleagues John Armstrong and Jean Downie said in today’s eight- page study . Gibbs and Armstrong are on the emeritus faculty at the Australian National University in Canberra and Downie is affiliated with the Centre for Infectious Diseases and Microbiology Laboratory Services at Sydney’s Westmead Hospital, according to the study. While the exact source of the new H1N1 strain is a mystery, their research has “raised many new questions,” they said. The authors compared the genetic blueprints of flu strains stored in the free database Genbank and found the pandemic virus’s nearest ancestors circulate in pigs. ‘Simplest Explanation’ While migratory birds may have acted as conduit for their convergence, human involvement in bringing them together is “by far the simplest explanation,” Gibbs said in a telephone interview today. Gibbs wrote or coauthored more than 250 scientific publications on viruses, mostly pertaining to the plant world, during his 39-year career at the Australian National University, according to biographical information on the university’s Web site. “Knowing Adrian Gibbs, he will have thought through it pretty logically and come to that conclusion,” Lance Jennings , a clinical virologist with Canterbury Health Laboratories in Christchurch, New Zealand, said in a telephone interview. “It’s up to someone else to try and prove it or disprove it.” To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@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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Hockey Players Jump Swine Flu Vaccine Queue, Sparking Outrage in Canada

November 6, 2009

By Frederic Tomesco and Sonja Franklin Nov. 6 (Bloomberg) — Canada’s chief medical officer criticized professional hockey and basketball players who jumped the queue for swine flu shots as the nation copes with a shortage of the vaccine. Teams including the National Hockey League’s Calgary Flames and Toronto Maple Leafs vaccinated some of their players last week, even as health officials try to limit the shots to high- risk patients such as pregnant women and young children. “We do love our hockey, but the guidelines are based on those who are at greatest risk,” Dr. David Butler-Jones , Chief Public Health Officer of Canada, said yesterday. “Those at lower risk really should wait. Hockey players are at no greater risk than anyone else.” The preferential treatment given to the athletes has sparked outrage even in a country where hockey is the most popular sport. Canada faces a shortage of flu vaccines, and in Alberta, where the Flames are based, lineups and a dwindling supply of vaccines forced the government to shut all clinics from Oct. 31 until yesterday. “I feel cheated,” said Brian Brown, 57, a poker dealer at a casino in Calgary. “I don’t blame the players, but the health region shouldn’t have agreed to give the shots without the public knowing.” The head of Alberta’s health services agency apologized for the “unacceptable” treatment given the Flames, and at least one person was fired as a result. “The decision to allow preferential access to the Flames and their families was a serious error in judgment,” Dr. Stephen Duckett, head of Alberta Health, said in a statement. Players Ill Sports teams such as the Flames say they want to avoid playing part of the six-month regular season with a depleted lineup. David Krejci , a forward with the Boston Bruins, yesterday became at least the fourth NHL player to be diagnosed with the virus. “Our organization and our medical staff felt that our players should receive the vaccination given the risks associated with frequent physical contact,” the Flames said in a Nov. 3 statement on the team’s Web site. “Our players did not seek to either avoid line-ups or get special attention.” Quebec’s Major Junior Hockey League had to cancel two games involving the Moncton Wildcats this week after two players on the team contracted the virus. Affected players and staff have been quarantined, the league said. Ontario Health Minister Deb Matthews said she wants to know why players and staff of the Maple Leafs and the National Basketball Association’s Toronto Raptors got the vaccine. Maple Leaf Sports and Entertainment, the owner of both clubs, said in a statement that “certain players and staff” received the shot. Priority List “I want you to know that this is entirely, entirely unacceptable,” Matthews told the provincial legislature in Toronto. “We are relying on our professionals to respect the priority list.” Canadians will have to be patient. Quebec Health Minister Yves Bolduc told a televised news conference yesterday that all residents will be able to get the vaccine by Christmas. About 700,000 of the province’s 7.8 million residents have been vaccinated, he said. Lineups in Quebec have been so long that the government this week set up a coupon system to avoid people having to spend hours in near-freezing temperatures as they waited for their turn. As of Nov. 3, 101 people in Canada have died from swine flu since the outbreak of the virus, Canadian health officials said yesterday. In the past week, swine-flu cases across the country have tripled, Butler-Jones said. On Oct. 27, a 13-year-old Toronto hockey player died from the virus just a day after developing flu-like symptoms. Evan Frustaglio died after fainting in the bathroom of his home, his father Paul Frustaglio said. To contact the reporter for this story: Frederic Tomesco in Montreal at tomesco@bloomberg.net .

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Novartis’s Celtura Cell-Culture Based Swine Flu Shot Wins German Backing

November 5, 2009

By Dermot Doherty Nov. 5 (Bloomberg) — Novartis AG won German regulatory approval for its Celtura swine flu vaccine. The country’s health regulator approved Celtura shots for use in adults and children as young as six months old, Basel, Switzerland-based Novartis said today in an e-mailed statement. Celtura is produced using dog kidney cells rather than the more traditional vaccine-manufacturing method, which involves growing the virus in fertilized chicken eggs. The approval marks an “important milestone” in the process of replacing 50-year-old production methods with modern biotechnology, Novartis said. The cell culture technology has already been approved in Europe for use in producing the seasonal flu vaccine Optaflu. Novartis has also asked Swiss and Japanese regulators to approve Celtura. “Our modern cell culture technology can enable a faster start-up of vaccine manufacturing, offering the ability to respond more quickly to future pandemic threats,” Andrin Oswald , Chief Executive Officer of Novartis Vaccines and Diagnostics said in the statement. “We quickly ramped up capacity at our licensed cell culture facility in Marburg, Germany to respond to the need for a pandemic vaccine.” The company has already won European and Swiss approval for its Focetria vaccine, which is made in the traditional way. Adjuvants Neither Celtura nor Focetria was submitted for use in the U.S. because of the use of a so-called adjuvant, which hasn’t been approved in the country. Adjuvants boost the potency of a vaccine and enable the same amount of antigen, or the substance that induces immunity, to be used to treat more people. The MF59 adjuvant used in Celtura has already been used in more than 45 million doses of the flu shot Fluad and is supported by more than 12 years of clinical safety data, Novartis said. Clinical studies in more than 1,850 people showed that a single dose of Celtura can induce an immune response “associated with protection against influenza” in people aged between 3 and 50 years, Novartis said. To contact the reporter on this story: Dermot Doherty in Geneva at ddoherty9@bloomberg.net

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Swine Flu Killed Older Adults More Than Young in California’s Hospitals

November 3, 2009

By Nicole Ostrow Nov. 3 (Bloomberg) — Swine flu is almost three times more likely to kill patients older than 50 once they become hospitalized than those younger than 18, a study found. Young people are still more likely than older adults to be infected, and the vast majority of H1N1 cases carry only mild symptoms. Among 1,088 people hospitalized in California, about 20 percent of those aged 50 and older died compared with 7 percent of those 18 and younger, according to a study today in the Journal of the American Medical Association. The reason for the discrepancy among hospitalized patients in different age groups is that the older a person is the more likely they’ll also have other medical conditions, said William Schaffner , a liaison to the U.S. government’s vaccine advisory panel who didn’t work on the study. “They’re much more likely to have a serious underlying illness such as diabetes, heart disease or underlying lung disease,” said Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University in Nashville, Tennessee, in an Oct. 30 telephone interview. Those older than 50 may have some immunity to swine flu, also known as H1N1, which is why they aren’t getting sick as often as young adults and children, said study author, Janice Louie, of the California Department of Public Health , which conducted the research. Healthy older adults should still wait to be vaccinated until more of the vaccine becomes available, Schaffner said. Children ages 6 months to 24 years and pregnant women are the highest priority groups for getting the swine flu vaccine, according to the Atlanta-based CDC’s guidelines. 530 People Killed Swine flu, also known as H1N1 influenza, killed 530 people in 28 states from Aug. 30 to Oct. 24 and accounted for 12,466 hospitalizations nationwide, according to CDC . In today’s study, researchers looked at state residents who were hospitalized or died with laboratory evidence of swine flu between April 23 and Aug. 11. Among 1,088 cases studied, 32 percent were in children younger than 18, with infants having the highest rate of hospitalization. Fever, cough and shortness of breath were the most common symptoms. Overall, 118 people died, including eight children younger than 18 years and 51 people aged 50 and older. The most common causes of death were viral pneumonia and acute respiratory distress syndrome, the authors said. The CDC said nationwide numbers aren’t available for how many people aged 50 and older have died of swine flu after being hospitalized with the virus. Last week the agency said that swine flu has killed 114 children in the U.S. since the outbreak surfaced in April, including 19 reported in the week from Oct. 18 to Oct. 24. Flu activity is now widespread in 48 U.S. states, the CDC said last week. Underlying Conditions Nearly 70 percent of those hospitalized in the study with swine flu had underlying conditions. In adults those conditions included asthma, diabetes and chronic obstructive pulmonary disease. In younger people the conditions included seizure disorders or cerebral palsy. Of those hospitalized, 340 were admitted to intensive care units and a majority of the 297 with available information on them required mechanical ventilation. Seasonal flu kills about 36,000 people a year in the U.S. People older than 64 years, younger than five or who have specific medical conditions have higher rates of hospitalization and death from seasonal flu, the authors said. To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@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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Merck Wins Approval to Offer Gardasil as Genital Warts Protection for Boys

October 16, 2009

By Shannon Pettypiece Oct. 16 (Bloomberg) — Merck & Co. ’s Gardasil, a vaccine used to prevent cervical cancer in women, won U.S. regulatory approval for preventing genital warts in boys. The U.S. Food and Drug Administration cleared the vaccine for use in males ages 9 to 26, Merck said today in a statement. Gardasil protects against a sexually transmitted infection called human papillomavirus, or HPV, that can lead to cervical cancer in women and genital warts and cancer of the penis and anus in men. Gardasil, approved for females ages 9 to 26, is given mostly to school-age girls as a U.S.-recommended routine vaccination. Expanding the shot’s use could revive sales , which declined 5 percent last year, analysts have said. “This is an important milestone, because the use of Gardasil can now help protect boys and girls and young men and women from certain diseases caused by this common virus,” said Richard Haupt , executive director of Merck Research Laboratories, in the company’s statement. Approval in boys could add as much as $200 million and $300 million in annual sales, said Leerink Swann & Co. analyst Seamus Fernandez in a research report last month. Gardasil generated revenue of $1.4 billion last year. Merck , based in Whitehouse Station, New Jersey, fell 6 cents, or less than 1 percent, to $33.24 at 1:26 p.m. in New York Stock Exchange composite trading. Difficult Market Selling Gardasil for boys could be a struggle for Merck because the public-health benefit may not outweigh the expense, Fernandez said. It would cost more than $100,000 to vaccinate enough boys to get one year of additional life compared with less than $50,000 for girls, according to a study by Harvard University researchers presented in June to the U.S. Centers for Disease Control and Prevention. Merck’s studies show it would cost $50,000 for both boys and girls. Merck’s study used a cost of $400 per vaccine with 100 percent protection. Researchers used a measure called quality adjusted life years, or QALYs, that evaluate years of life saved as well as assigning a fraction of a year for years spent without certain diseases. Merck will expand a patient rebate and dose replacement program to help cover the cost of the vaccine for 19- to 26- year-old men without health insurance and those with private insurance with partial or no coverage for the shots, according to the company’s statement. Company Study In a Merck-funded study released last year, researchers gave 4,065 boys and men ages 16 to 26 the vaccine or a placebo, then tracked them for signs of infection with HPV. After about 30 months, three men getting Gardasil developed genital warts and none had pre- cancerous growths linked to the HPV virus, compared with 28 cases of warts and three pre-cancerous lesions in the placebo group. Gardasil, which is given in three shots over a six- month period, protects against infection caused by HPV types 6, 11, 16 and 18 — four of the 40 types of the virus found in the genital area. More than 1 million cases of genital lesions, which can lead to cancer, occur in men and women in the U.S. each year, and 30 million cases occur worldwide, according to Merck. While 20 million Americans are infected with HPV, most will be able to fight off the infection naturally. About 1 percent of sexually active men in the U.S. will develop genital warts from HPV, the CDC said. Gardasil is already approved for males in 40 countries worldwide. To contact the reporter responsible for this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net .

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Swine Flu Fueled 15-Fold Rise in Intensive Care Lung Cases in Australia

October 8, 2009

By Tom Randall Oct. 8 (Bloomberg) — Swine flu was found responsible for a 15-fold increase in intensive care unit admissions for lung inflammation in Australia and New Zealand, in the first detailed study of how the virus strikes in winter. During the peak of severe illness, swine flu patients filled 8.9 percent to 19 percent of all intensive-care hospital beds in each state of Australia and Zealand, according to the study published today in the New England Journal of Medicine . Almost 65 percent of intensive-care patients required mechanical ventilation. The Southern Hemisphere’s winter flu season, studied from June 1 to Aug. 31, may give health officials in the U.S. and Europe an early indication of what to expect in coming months, the researchers said today. The pandemic filled all available beds in some units and prompted doctors to postpone nonessential surgery, New Zealand’s health ministry said in July. “Our data indicate that the greatest effect on ICU resources in a given region occurs approximately 5 to 6 weeks after the first confirmed winter admission,” wrote the researchers from the Australian and New Zealand Intensive Care Society. “The 2009 H1N1 virus had a substantial effect.” H1N1 rates have subsided in the Southern Hemisphere, and the virus is now spreading widely in most U.S. states, according to the U.S. Centers for Disease Control and Prevention. The official winter flu season started in the U.S. on Oct. 4, and U.S. doctors began administering vaccines this week in the country’s largest flu vaccination program. Patients most at risk for severe complications in the study included infants under 1 year old, adults ages 26 to 64, pregnant women, the obese, and indigenous populations, according to the researchers. More than 16 percent of patients admitted to hospitals died, and a third of severely ill people had no underlying condition that would elevate their risk, according to the study. To contact the reporters on this story: 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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AIDS Vaccine First to Block HIV Infection in Sanofi, VaxGen Thailand Study

September 24, 2009

By Simeon Bennett Sept. 24 (Bloomberg) — A vaccine prevented some AIDS infections for the first time, a breakthrough in a search that has eluded scientists for a quarter century. A U.S.-funded study involving more than 16,000 volunteers in Thailand found that a combination of ALVAC, made by Paris- based Sanofi-Aventis SA , and AIDSVAX, a product of VaxGen Inc., of South San Francisco, cut infections by 31.2 percent in the group who received it compared with those on a placebo, scientists said today in Bangkok. Neither vaccine had stopped the virus when tested independently in previous studies. The finding represents a revival in a campaign that appeared to stall just two years ago when use of Merck & Co. ’s experimental Ad5 vaccine boosted some people’s chances of infection in a study. The latest result will transform future research, said Mitchell Warren, director of the New York-based AIDS Vaccine Advocacy Coalition. “Wow,” said Warren, who was not involved in the study, in a telephone interview today. “We are in a new place in the search for an AIDS vaccine. It’s safe to say that the scientific community is caught off-guard.” The findings don’t mean the vaccine can be delivered worldwide, because of the complexity of the process and the fact that it’s based on old technology, Warren said. Instead they will serve to spur scientists to look for better combinations in more user-friendly regimens, and higher success rates, he said. Different Strategies The Thailand study looked at whether different infection- fighting strategies devised by Sanofi and VaxGen could be combined into a two-pronged attack. It was conducted by Thailand’s Ministry of Public Health over six years, and led by researcher Supachai Reks-Gnarm. Sanofi’s ALVAC uses a canarypox virus that’s been disabled so it doesn’t cause sickness in humans to smuggle three HIV genes into the body. It’s designed to coax the immune system to make so-called T-cells, immune system protectors that hunt and kill infection deep inside the body. The AIDSVAX shot contains an HIV protein called gp120 that’s used by the virus to enter human cells. It is designed to encourage the body to produce neutralizing antibodies to destroy HIV viruses before they can infect healthy cells. “That’s what makes it so exciting,” Warren said. “We now have proof of concept that a combination vaccine regimen stimulating both arms of the immune system can have an effect.” The search for a vaccine to prevent HIV has eluded scientists since the early 1980s. AIDS, the syndrome linked with HIV, infects about 6,800 new people globally every day. While there are treatments for HIV that limit the virus in the body, holding AIDS at bay for years, there is no cure. Merck Vaccine “This is the first concrete evidence, since the discovery of the virus in 1983, that a vaccine against HIV is eventually feasible,” Michel DeWilde , senior vice president of research at Sanofi Pasteur, the French drugmaker’s vaccine arm, said in a statement today. An international test of the Ad5 vaccine made by Whitehouse Station, New Jersey-based Merck in about 3,000 people was halted in September 2007, when 49 HIV infections occurred among those who received it compared with 33 among those who got placebo shots. That suggested the product may have raised HIV risk among people exposed to blood or semen containing the virus. In 2004, a group of U.S. AIDS researchers said in a letter to the journal Science that the combination trial would probably disappoint, and shouldn’t be allowed to proceed because of the failure of the two previous studies. Highest HIV Rates In a telephone interview from Oxford, England, before the results were reported, Marie-Paule Kieny , director of the World Health Organization’s Initiative for Vaccine Research in Geneva, said, “I don’t think there is a lot of expectation that the efficacy of this vaccine will be very high. Any hint towards identifying something which is protective in humans would be very good news,” she said. The researchers enrolled volunteers in Thailand’s Chon Buri and Rayong provinces, which have the nation’s highest rates of HIV, according to the study Web site. Subjects were given four doses of the ALVAC vaccine and two of the AIDSVAX shot over six months, then monitored for three years. They were also given advice on safe sex. There were no serious side effects, the researchers said. Of those who received the vaccine, 51 became infected with HIV, compared with 74 who received a placebo, the researchers said. Those in the study who became infected with HIV during the trial were given free access to treatment. ‘Change Some Ideas’ “Although the results were modest, with an efficacy of 31.2 percent, this is a very important scientific advance, and gives us hope that a globally effective HIV vaccine may be possible in the future,” said Jerome Kim, a deputy director of science at the Walter Reed Army Institute of Research, which sponsored the trial. “It has already caused us to change some of our ideas,” Kim told reporters. VaxGen, a venture spun off in 1995 from South San Francisco, California-based biotech company Genentech Inc., stopped developing AIDSVAX in 2003 after a trial showed it didn’t prevent people from getting HIV. The Global Solutions for Infectious Diseases , a South San Francisco-based non-profit organization, acquired the rights to the product. The Thailand trial was funded by the National Institute of Allergy and Infectious Diseases, the National Institutes of Health and the U.S. Army Medial Research and Materiel Command. To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net .

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AIDS Vaccine Shows Promise for First Time in Sanofi, VaxGen Thailand Study

September 24, 2009

By Simeon Bennett Sept. 24 (Bloomberg) — An HIV vaccine has for the first time been proven effective against the virus responsible for AIDS, according to a U.S.-funded study involving more than 16,000 volunteers in Thailand. A combination effort that includes ALVAC, made by Paris- based Sanofi-Aventis SA , and AIDSVAX, a product of VaxGen Inc., of South San Francisco, prevented infections in 31.2 percent of people in the trial compared with those on a placebo, scientists said today in Bangkok. Neither vaccine had stopped the virus when tested independently in previous studies. The finding represents a revival in a quarter-century long campaign that appeared to stall just two years ago when use of Merck & Co. ’s experimental Ad5 vaccine boosted some people’s chances of infection in a study that was terminated. The newest result will transform future research, said Mitchell Warren, director of the New York-based AIDS Vaccine Advocacy Coalition. “Wow,” said Warren, who was not involved in the study, in a telephone interview today. “We are in a new place in the search for an AIDS vaccine. It’s safe to say that the scientific community is caught off-guard.” The findings don’t mean the vaccine can be delivered worldwide, because of the complexity of the process and the fact that it’s based on old technology, Warren said. Instead they will serve to spur scientists to look for better combinations in more user-friendly regimens, and higher success rates, he said. Different Strategies The Thailand study looked at whether different infection- fighting strategies devised by Sanofi and VaxGen could be combined into a two-pronged attack. It was conducted by Thailand’s Ministry of Public Health over six years, and led by researcher Supachai Reks-Gnarm. Sanofi’s ALVAC uses a canarypox virus that’s been disabled so it doesn’t cause sickness in humans to smuggle three HIV genes into the body. It’s designed to coax the immune system to make so-called T-cells, immune system protectors that hunt and kill infection deep inside the body. The AIDSVAX shot contains an HIV protein called gp120 that’s used by the virus to enter human cells. It is designed to encourage the body to produce neutralizing antibodies to destroy HIV viruses before they can infect healthy cells. “That’s what makes it so exciting,” Warren said. “We now have proof of concept that a combination vaccine regimen stimulating both arms of the immune system can have an effect.” The search for a vaccine to prevent HIV has eluded scientists since the early 1980s. AIDS, the syndrome linked with HIV, infects about 6,800 new people globally every day. While there are treatments for HIV that limit the virus in the body, holding AIDS at bay for years, there is no cure. Merck Vaccine An international test of the Ad5 vaccine made by Whitehouse Station, New Jersey-based Merck in about 3,000 people was halted in September 2007, when 49 HIV infections occurred among those who received it compared with 33 among those who got placebo shots. That suggested the product may have raised HIV risk among people exposed to blood or semen containing the virus. In 2004, a group of U.S. AIDS researchers said in a letter to the journal Science that the combination trial would probably disappoint, and shouldn’t be allowed to proceed because of the failure of the two previous studies. In a telephone interview from Oxford, England, before the results were reported, Marie-Paule Kieny , director of the World Health Organization’s Initiative for Vaccine Research in Geneva, said, “I don’t think there is a lot of expectation that the efficacy of this vaccine will be very high. Any hint towards identifying something which is protective in humans would be very good news,” she said. Highest HIV Rates The researchers enrolled volunteers in Thailand’s Chon Buri and Rayong provinces, which have the nation’s highest rates of HIV, according to the study Web site. Subjects were given four doses of the ALVAC vaccine and two of the AIDSVAX shot over six months, then monitored for three years. They were also given advice on safe sex. There were no serious side effects, the researchers said. Those in the study who became infected with HIV during the trial were given free access to treatment. VaxGen, a venture spun off in 1995 from South San Francisco, California-based biotech company Genentech Inc., ceased development of AIDSVAX in 2003 after a trial showed it didn’t prevent people from getting HIV. The Global Solutions for Infectious Diseases , a South San Francisco-based non-profit organization, acquired the rights to AIDSVAX. The trial was funded by the National Institute of Allergy and Infectious Diseases, the National Institutes of Health and the U.S. Army Medial Research and Materiel Command. To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net .

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European Stocks, U.S. Futures Drop; BHP Billiton, Hennes & Mauritz Decline

September 24, 2009

By Daniela Silberstein Sept. 24 (Bloomberg) — European and U.S. stock-index futures slid and most Asian shares fell on speculation a six- month rally has outpaced the prospects for earnings as the Federal Reserve nears the end of efforts to lift the economy. BHP Billiton Ltd., the world’s biggest mining company, declined in Sydney. Royal Dutch Shell Plc may retreat as oil decreased for a second day in New York. Aiful Corp., Japan’s second-largest consumer lender by assets, tumbled 24 percent after forecasting a full-year loss. Futures on the Dow Jones Euro Stoxx 50 Index, a benchmark for the euro region, retreated 0.6 percent as of 7:22 a.m. in London. The U.K.’s FTSE 100 Index may drop 20, according to Cantor Index. The MSCI Asia Pacific Index lost 0.1 percent, while shares advanced in Japan, where trading resumed after a three-day holiday. Standard & Poor’s 500 Index futures dropped 0.2 percent. The benchmark index for U.S. equities fell yesterday as the Fed signaled it will use fewer tools to bolster economic growth. The central bank, following a two-day policy meeting, changed the wording in the final paragraph of its statement to say it will continue to employ a “wide range of tools” to bolster the economy. In its August statement, it said it would use “all available” tools. The Fed left its target rate for overnight loans between banks in a record-low range between zero and 0.25 percent, and said it will stay “exceptionally low” for an “extended period.” The central bank said the economy has “picked up,” activity in the housing industry has increased, household spending seems to have stabilized and businesses are cutting back on investments and staffing at a slower pace. Six-Month Rally The S&P 500 has climbed 57 percent and Europe’s Stoxx 600 has soared 55 percent since March 9 as earnings at companies from Goldman Sachs Group Inc. to GlaxoSmithKline Plc surpassed projections and the German and French economies unexpectedly exited recessions. The rally has pushed valuations on the S&P 500 to 19.8 times the reported earnings of its companies, the highest level since 2004, while the Stoxx 600 is valued at 47.5 times reported profit, the most expensive level since 2003, according to weekly data compiled by Bloomberg. Leaders from the Group of 20 nations will meet in Pittsburgh today and tomorrow to work on an accord to prevent a repeat of the worst financial crisis since the Great Depression and ensure a sustained recovery. U.S. President Barack Obama and his counterparts may be saddled with the weakest recovery since World War II if they are to pay off the $9 trillion tab they ran up rescuing the world economy. BHP, Shell BHP declined 1.5 percent to A$37.78 in Australia, while Rio Tinto Group, the world’s third-largest mining company, slid 1.4 percent to A$60.87. Aluminum, lead, nickel and tin fell on the London Metal Exchange. Shell, BP Plc and Total SA may retreat as oil declined as much as 1.3 percent to $68.10 a barrel on the New York Mercantile Exchange. A U.S. government report showed a larger- than-expected increase in fuel stockpiles in the world’s largest energy-consuming nation. Hennes & Mauritz AB , Europe’s second-largest clothing retailer, said third-quarter net income rose to 3.46 billion kronor ($500 million) from 3.33 billion kronor a year earlier. Analysts had estimated a profit of 3.5 billion kronor, according to a survey compiled by Bloomberg. Sanofi, AstraZeneca Sanofi-Aventis SA may be active. An HIV vaccine has for the first time been proven effective against the virus responsible for AIDS, according to a U.S.-funded study involving more than 16,000 volunteers in Thailand. A combination effort that includes ALVAC, made by Sanofi-Aventis, and AIDSVAX, a product of VaxGen Inc., prevented infections in 31.2 percent of people in the trial compared with those on a placebo, scientists said. AstraZeneca Plc may move. The U.K. drugmaker was cut to “sell” from “neutral” by Goldman Sachs Group Inc. as gains made on positive results for the Brilinta clot-fighting medicine give way to concern that generic competition may erode sales. Aiful sank 24 percent to 102 yen in Tokyo on its loss forecast and plans to cut as much as 44 percent of its workforce. A report today may show sales of existing U.S. homes climbed in August to the highest level in two years, another sign the real-estate collapse that triggered the global recession is abating, economists said. Separate data from the Labor Department is projected to show the number of Americans seeking jobless benefits rose last week. To contact the reporter on this story: Daniela Silberstein in Zurich at dsilberstei2@bloomberg.net .

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European Stocks, U.S. Futures Drop; BHP Billiton, Hennes & Mauritz Decline

September 24, 2009

By Daniela Silberstein Sept. 24 (Bloomberg) — European and U.S. stock-index futures slid and most Asian shares fell on speculation a six- month rally has outpaced the prospects for earnings as the Federal Reserve nears the end of efforts to lift the economy. BHP Billiton Ltd., the world’s biggest mining company, declined in Sydney. Royal Dutch Shell Plc may retreat as oil decreased for a second day in New York. Aiful Corp., Japan’s second-largest consumer lender by assets, tumbled 24 percent after forecasting a full-year loss. Futures on the Dow Jones Euro Stoxx 50 Index, a benchmark for the euro region, retreated 0.6 percent as of 7:22 a.m. in London. The U.K.’s FTSE 100 Index may drop 20, according to Cantor Index. The MSCI Asia Pacific Index lost 0.1 percent, while shares advanced in Japan, where trading resumed after a three-day holiday. Standard & Poor’s 500 Index futures dropped 0.2 percent. The benchmark index for U.S. equities fell yesterday as the Fed signaled it will use fewer tools to bolster economic growth. The central bank, following a two-day policy meeting, changed the wording in the final paragraph of its statement to say it will continue to employ a “wide range of tools” to bolster the economy. In its August statement, it said it would use “all available” tools. The Fed left its target rate for overnight loans between banks in a record-low range between zero and 0.25 percent, and said it will stay “exceptionally low” for an “extended period.” The central bank said the economy has “picked up,” activity in the housing industry has increased, household spending seems to have stabilized and businesses are cutting back on investments and staffing at a slower pace. Six-Month Rally The S&P 500 has climbed 57 percent and Europe’s Stoxx 600 has soared 55 percent since March 9 as earnings at companies from Goldman Sachs Group Inc. to GlaxoSmithKline Plc surpassed projections and the German and French economies unexpectedly exited recessions. The rally has pushed valuations on the S&P 500 to 19.8 times the reported earnings of its companies, the highest level since 2004, while the Stoxx 600 is valued at 47.5 times reported profit, the most expensive level since 2003, according to weekly data compiled by Bloomberg. Leaders from the Group of 20 nations will meet in Pittsburgh today and tomorrow to work on an accord to prevent a repeat of the worst financial crisis since the Great Depression and ensure a sustained recovery. U.S. President Barack Obama and his counterparts may be saddled with the weakest recovery since World War II if they are to pay off the $9 trillion tab they ran up rescuing the world economy. BHP, Shell BHP declined 1.5 percent to A$37.78 in Australia, while Rio Tinto Group, the world’s third-largest mining company, slid 1.4 percent to A$60.87. Aluminum, lead, nickel and tin fell on the London Metal Exchange. Shell, BP Plc and Total SA may retreat as oil declined as much as 1.3 percent to $68.10 a barrel on the New York Mercantile Exchange. A U.S. government report showed a larger- than-expected increase in fuel stockpiles in the world’s largest energy-consuming nation. Hennes & Mauritz AB , Europe’s second-largest clothing retailer, said third-quarter net income rose to 3.46 billion kronor ($500 million) from 3.33 billion kronor a year earlier. Analysts had estimated a profit of 3.5 billion kronor, according to a survey compiled by Bloomberg. Sanofi, AstraZeneca Sanofi-Aventis SA may be active. An HIV vaccine has for the first time been proven effective against the virus responsible for AIDS, according to a U.S.-funded study involving more than 16,000 volunteers in Thailand. A combination effort that includes ALVAC, made by Sanofi-Aventis, and AIDSVAX, a product of VaxGen Inc., prevented infections in 31.2 percent of people in the trial compared with those on a placebo, scientists said. AstraZeneca Plc may move. The U.K. drugmaker was cut to “sell” from “neutral” by Goldman Sachs Group Inc. as gains made on positive results for the Brilinta clot-fighting medicine give way to concern that generic competition may erode sales. Aiful sank 24 percent to 102 yen in Tokyo on its loss forecast and plans to cut as much as 44 percent of its workforce. A report today may show sales of existing U.S. homes climbed in August to the highest level in two years, another sign the real-estate collapse that triggered the global recession is abating, economists said. Separate data from the Labor Department is projected to show the number of Americans seeking jobless benefits rose last week. To contact the reporter on this story: Daniela Silberstein in Zurich at dsilberstei2@bloomberg.net .

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Swine Flu Vaccines May Begin in Three Weeks as U.S. Cases Spread, CDC Says

September 13, 2009

By Tom Randall and Jason Gale Sept. 13 (Bloomberg) — Swine flu vaccinations may begin in three weeks, earlier than previously anticipated, after the first U.S. tests found a single shot to be effective in eight to 10 days, U.S. health officials said. The first shots may be available by the end of this month and administered to patients the first week of October, said Nancy Cox, director of the flu division at the U.S. Centers for Disease Control and Prevention in Atlanta. Health officials had previously planned for vaccinations to begin in mid-October, requiring two shots administered three weeks apart. Swine flu outbreaks have rippled across U.S. schools and universities after pupils returned to classes in the past few weeks. Washington State University reported more than 2,500 cases, and the CDC last week reported a nationwide spike of influenza cases months earlier than the past three flu seasons. The test results are boosting hopes the vaccine may be available in time to curb the first pandemic in 41 years, Cox said. “We were anticipating that it would begin mid-October,” Cox told reporters today at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco. “This was a conservative estimate but it was a necessary conservative estimate. We now feel that we will have vaccine for more people earlier and this is extremely good news.” New Virus Health authorities in the U.S. and U.K. anticipated that two shots would be required because people were being exposed to the new virus for the first time. Critics said a multidose regime wouldn’t come in time to slow widespread outbreaks in the U.S. already triggered by the start of schools. Shots now also may be available in time to bring relief in the Southern Hemisphere, where swine flu recently peaked. The U.S. study was the first report from five government- sponsored trials initiated July 22 to test safety and proper dosing of a pandemic vaccine. They bolster similar results published by Melbourne-based CSL Ltd., said Anthony Fauci , director of the National Institute of Allergy and Infectious Disease in Bethesda, Maryland, in an interview. The CSL study found that more than 95 percent of 240 patients who were given a single shot had protective antibodies three weeks later. The successful test results may double anticipated stockpiles of the vaccine and make more shots available in developing countries, Cox said today. The U.S. is in “very active discussions” about donating some of its supply to countries that need it, she said. One Dose Effective The results of the vaccine studies suggest one dose of the formula used by drugmakers should offer H1N1 protection similar to the seasonal flu shot. Paris-based Sanofi Aventis SA , London- based GlaxoSmithKline Plc , and Basel, Switzerland-based Novartis AG are among the other companies making the vaccine. Vaccine supplies in early October will be limited and targeted at health-care workers and those most vulnerable to severe illness, such as pregnant women and children, Cox said. “We’re on track to have an ample supply rolling by the middle of October,” Kathleen Sebelius , U.S. secretary of health and human services, said today on ABC’s “This Week” program. “We’ll get the vaccine out the door as fast as it rolls out the production line.” Most shots in the studies of healthy adults ages 18 to 64 contained 15 micrograms of antigen, the same level as for seasonal flu vaccines. The vaccinations had similar side effects to regular flu shots, the most common being headache and pain at the injection site. CSL said it plans to donate the vaccine to developing nations in Asia and the South Pacific and is discussing a pilot program with the World Health Organization to start by providing as many as 100,000 doses. The vaccines in both studies didn’t use ingredients called adjuvants included by some countries in formulations to boost effectiveness. No serious side effects were reported, though the trials are too small to detect rare conditions. The shots are being studied further and will be closely monitored once vaccination campaigns begin, according to U.S. officials. To contact the reporter on this story: Tom Randall in San Francisco at trandall6@bloomberg.net ; Jason Gale in San Francisco at j.gale@bloomberg.net .

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Swine Flu Vaccination Requires Just One Dose, Doubling Stockpile Estimates

September 10, 2009

By Tom Randall Sept. 10 (Bloomberg) — One dose of swine flu vaccine was enough to protect most people from contracting the pandemic virus, according to a study that may double the anticipated stockpiles and help people get immunized faster. A two-dose vaccine, administered three weeks apart, was widely anticipated to be necessary by scientists at the U.S. Centers for Disease Control and Prevention in Atlanta and the World Health Organization in Geneva. Today’s results suggest one dose of the formula used by drugmakers including Paris-based Sanofi Aventis SA and London-based GlaxoSmithKline Plc should offer swine-flu protection similar to the seasonal flu shot. Twenty-one days after a first shot was given, about 95 percent of the 240 patients had achieved levels of protective antibodies sufficient to fight off the disease, according to the study published online today in the New England Journal of Medicine . The study was conducted by Melbourne, Australia-based CSL Ltd., which makes 19 percent of the U.S. stockpile and Australia’s sole supplier of pandemic vaccine. “I’ve heard it referred to as jaw-dropping,” said Paul Perreault, president of CSL Biotherapies, CSL’s vaccine unit. “It’s pretty similar to the seasonal vaccine, which is very good news. There’s enough data here to indicate that it’s probably going to be one dose.” CSL has agreed to provide 21 million doses to Australia and 36 million doses to the U.S., Perreault said. The U.S., which contracts with five companies, anticipates 45 million doses of its 195 million available for use by mid-October. No Adjuvant The vaccine in today’s study didn’t use ingredients called adjuvants included by some countries in formulations to boost effectiveness. No serious side effects were reported in the study. Swine flu has become the world’s fastest-moving influenza pandemic, sweeping across 177 countries in the four months since it was first identified, the CDC said. More than 1 million people have already contracted the virus in New York alone, according to estimates by the city’s health department. “In our current global situation, in which demand for influenza vaccine greatly exceeds supply, dose-sparing strategies are needed,” said Kathleen Neuzil , an infectious disease specialist at the University of Washington in Seattle, in an editorial that accompanied the journal study. Today’s study was conducted in Australia, though U.S. regulators will use it as part of their evaluation of the vaccine, Perreault said. The U.S. National Institutes of Health is conducting separate studies. To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

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Glaxo Adds Face Masks to Flu Franchise as Sales Soar from Global Outbreak

July 31, 2009

By Trista Kelley July 31 (Bloomberg) — GlaxoSmithKline Plc may reap 1.53 billion pounds ($2.52 billion) of sales from the outbreak of pandemic flu in the next six months, and that’s before the drugmaker introduces its latest influenza product.

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Pregnant Women Account for One of Eight Swine Flu Fatalities, Lancet Says

July 29, 2009

By Jason Gale July 29 (Bloomberg) — Swine flu in pregnancy can cause life-threatening disease and warrants treatment with antiviral drugs as soon as possible, a study in the medical journal Lancet found. The study, to be published in the Aug

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Teenagers May Be at Greater Risk of Catching Swine Flu, UN Agency Finds

July 25, 2009

By Jason Gale July 25 (Bloomberg) — Younger people are at greater risk of catching swine flu, with most cases occurring in teenagers, the World Health Organization said.

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Chimpanzees in the Wild Do Get Sick from AIDS After All, Researchers Find

July 22, 2009

By Rob Waters July 22 (Bloomberg) — Chimpanzees, the closest animal relatives to humans, may sicken and die from a simian version of AIDS, contrary to scientists’ assumptions, researchers reported today in the journal Nature . The scientists followed 94 wild chimps for nine years at a national park in Tanzania and found that animals infected with a version of the simian immunodeficiency virus , or SIV, had a 10- to-16 fold higher risk of dying early than did uninfected chimps.

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First Pandemic Vaccine for Swine Flu Goes Into Testing by Australia’s CSL

July 21, 2009

By Simeon Bennett July 21 (Bloomberg) — The first human trials of a swine- flu vaccine are set to begin in Australia as deaths and infections from the H1N1 virus mount worldwide, intensifying demand for a protective shot. CSL Ltd.

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Circumcising HIV-Infected Men Doesn’t Stop Transmission to Women Partners

July 19, 2009

By Carey Sargent July 17 (Bloomberg) — Circumcising men infected with HIV didn’t stop transmission of the virus to female partners, a study published in The Lancet medical journal found. The trial, which took place in Uganda, was stopped early after 18 percent of the female partners of the circumcised men became infected with the virus compared with 12 percent of the partners of men who hadn’t undergone the procedure

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