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

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

By Ellen Gibson March 16 (Bloomberg) — The U.S. government has spent $100 billion funding cancer research since then-President Richard Nixon declared the “ War on Cancer ” in 1971, says an editorial in the Journal of the American Medical Association . The death rate from all cancers fell by almost 16 percent from 1991 to 2006, the editorial said. Much of that decline came from anti-smoking campaigns and early disease detection, said the commentary by researchers at the American Cancer Society in Atlanta. While new drugs, led by Roche Holding AG ’s Avastin and Eli Lilly & Co. ’s Erbitux, are helping, the cost of medical care including these treatments is straining the U.S. health system, researchers at the Memorial Sloan-Kettering Cancer Center in New York said in a second commentary. Since 1990, cancer-related medical expenses have more than doubled to $90 billion, accounting for inflation, the second commentary said. The rate could be slowed by shifting to a system in which the cost of drugs, tests and other care are combined in a single- provider payment that would encourage doctors to “shop carefully for the services” patients need, the researchers wrote. “The expanding financial burden of cancer” including rising incidence rates “cannot be ignored,” wrote the commentary authors, led by Elena Elkin . This week’s special edition of the journal includes six editorials and commentaries assessing the country’s progress against cancer. Grouping Doctors The Sloan-Kettering researchers also suggested in their commentary that doctors and hospitals should be grouped into accountable-care organizations that would nudge physicians to act more cohesively, and could be rewarded by payers for providing care that delivers good results. Cancer remains the second-leading cause of death in the U.S., according to the American Cancer Society in Atlanta. In one survey cited in the journal, almost a quarter of respondents with health insurance said they used most or all of their savings during treatment for cancer. Avastin, the drug made by Roche of Basel, Switzerland, for breast, lung and colorectal cancer, can cost as much as $100,000 a year, according to UnitedHealth Group Inc. of Minnetonka, Minnesota, the biggest U.S. health insurer. Erbitux, the colon cancer treatment made by Indianapolis-based Lilly, can cost $40,000, said Les Funtleyder , a Miller Tabak & Co. LLC analyst in New York, in an e-mail today. High Bills Not only do high bills cause financial hardship for patients, they influence the choices doctors make, the authors said. In a separate survey noted in the editorial, 84 percent of oncologists said that concerns about patients’ out-of-pocket payments influenced their treatment decisions. The so-called war on cancer has led to $100 billion in cancer-research funding by U.S. agencies, according to a journal commentary written by Susan Gapstur , an epidemiologist at the American Cancer Society. These efforts resulted in a 1 percent annual drop in new cancer diagnoses between 1999 and 2006, her report said. There has been “remarkable progress” in the treatment of certain types of cancer, the report said, including breast cancer, Hodgkin’s disease , and testicular cancer . Almost 80 percent of children and adolescents diagnosed with cancer now survive at least five years, Gapstur said in a phone interview yesterday. Public Messages The main driver of progress has been public-health messages about tobacco use. The decrease in cigarette smoking in the U.S. over the past half-century accounts for 40 percent of the drop in cancer deaths in men since 1990, the year when the lung- cancer mortality rate for men peaked, Gapstur’s commentary said. “We’ve made progress, but people are still dying at too high a rate,” she said. “At the moment, we can’t put a dollar amount on when we stop. We have to continue our research efforts.” Early detection of colorectal and cervical cancers has reduced the mortality rates associated with those diseases. The challenge now, she said, is to improve early detection methods and enhance their usefulness. “For society, it’s less expensive to screen hundreds of people than to treat a single patient with cancer,” said Bert Vogelstein , co-director of the Johns Hopkins Ludwig Center in Baltimore, who is working to developing diagnostics to detect the genetic alterations that are seen in cancers. Aging Population There are a number of other challenges ahead, according to the report. An aging population means the number of cancer cases is likely to increase in the future, it said. Some cancers, including those of the liver , pancreas , and brain , are still linked to high mortality rates despite research efforts. As tobacco use wanes, the high rate of obesity in the U.S. could present a new public health challenge by raising cancer rates, Gapstur said. “Most epidemiologic studies have shown that obesity is a risk factor for cancer,” said Vogelstein in an interview yesterday. About 30 to 35 percent of all cancers can be attributed to nutrition, lack of physical activity, and obesity, Gapstur said. “Our concern is that, over time, that epidemic will have an impact on cancer mortality.” Gapstur’s essay notes that many articles have been written that are critical of the pace of progress in battling cancers and finding cures, especially in light of the “immense” economic costs. “We’ve been fighting this war on cancer since Nixon’s time, but we’ve only had the human genome for about a decade,” said Victor Velculescu , co-director of cancer biology at Johns Hopkins Kimmel Cancer Center . “It takes time to translate genetic info, but we’ve only just started getting it.” To contact the reporters on this story: Ellen Gibson in New York at egibson9@bloomberg.net ;

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Cancer Costs More Than Doubled Over 40 Years as Deaths Fell 16%, JAMA Says

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

March 5, 2010

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

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Gene Linked to Asthma May Show Connection to Allergies, Way to Treatments

December 24, 2009

By Ellen Gibson Dec. 23 (Bloomberg) — A gene linked to asthma susceptibility in children has been identified that may reveal the respiratory disease’s connection to allergies and lead to new treatment for 6 million U.S. child asthmatics, a study said. Researchers at the Children’s Hospital of Philadelphia analyzed the DNA of thousands of children to isolate the gene, called DENND1B, according to the study in today’s New England Journal of Medicine . The gene influences action on immune system cells involved in the body’s response to foreign material such as viruses, bacteria and allergens. This is the second gene found linked to asthma, a condition thought to be triggered by a combination of genetic and environmental causes, according to the study. Although the illness can be controlled by drugs, less than half of the 22 million asthmatics in the U.S. are properly managed, according to surveys from the American Lung Association . “You can use these findings to begin to tailor a new treatment approach for asthma,” said Norman Edelman , chief medical officer at the American Lung Association . “And with the huge asthma epidemic we’ve seen over the past 25 years, we certainly need a new approach.” The rate of asthma in the U.S. more than doubled to 7.1 percent of the population in 2004 from 3.1 percent in 1980, according to the U.S. Centers for Disease Control and Prevention, an Atlanta-based agency. Airways Asthma occurs when narrow or inflamed airways cause wheezing, coughing, chest tightness, and shortness of breath, according to the Mayo Clinic’s Web site . No cure exists for asthma, according to the National Institutes of Health , an agency in Bethesda, Maryland. It can be treated by inhaled steroids such as Symbicort, sold by London- based AstraZeneca Plc , and by Flonase from London-based GlaxoSmithKline Plc. Other researchers had found an asthma-susceptibility gene on chromosome 17 in 2007. In today’s study, researchers led by Hakon Hakonarson , the director of the Center for Applied Genomics at the Children’s Hospital of Philadelphia , isolated the DENND1B gene on chromosome 1. The gene may prove to be “an extremely strong drug target for asthma,” Hakonarson said yesterday in a telephone interview. Gene Analysis The researchers initially analyzed the genomes, or complete gene sets, of 793 white North American children with asthma, compared with a control group of 1,988 healthy children. They confirmed the results in a separate group of about 2,400 Europeans and controls, then did further analyses on about 3,700 black children. The scientists were able to duplicate earlier findings of the chromosome-17 gene, and they discovered the new DENND1B location on chromosome 1 that was strongly associated with the disease in the white and black children. Several genes are most likely involved in predisposing people to asthma, according to the report. The DENND1B gene the researchers pinpointed acts on dendritic cells that regulate the body’s immune response to trigger inflammation. After a foreign particle enters 22the airways, the dendritic cells pick it up, process it, and present it to an immune cell that may attack it in an allergic reaction. Link to Allergies About 70 percent of people with asthma also have allergies, according to the World Health Organization in Geneva, Switzerland. Because this gene seems to play “a critical role” in how sensitized the body is to allergens, Hakonarson said, it could advance research into that area as well. In follow-up studies, the researchers have found that DENND1B is also implicated in other immune and inflammatory diseases, although they haven’t yet reported that data. “It’s showing up as a very powerful gene,” Hakonarson said in a Dec. 22 phone interview. Genes and environment contribute to asthma, according to the Washington-based American Lung Association. If one parent has asthma, a child is three times more likely to get the disease, according to the lung association. Common environmental triggers of asthma include air pollution, mold, cockroach dust, and cigarette smoke, according to the CDC. Jobs that involve inhaling harmful substances, such as wood dust or smelting fumes, cause 11 percent of asthma cases, according to the World Health Organization, a United Nations agency. Drug Treatments Drug treatments for asthma include bronchodilators, which relax the muscles around the airway, providing quick relief during an asthma attack, and inhaled steroids, which are used over time to prevent swelling. While steroids are effective at managing the disease long- term, many people don’t use them, according to Edelman. Surveys by the lung association have found that the disease is properly controlled in less than 40 percent of asthmatics. He attributes this to the high cost of the drugs, coupled with the fact that inhaled therapies are cumbersome to use. “We’ve made a lot of progress in the treatment of asthma,” said Edelman, “but we could really use another class of drugs.” To contact the reporters on this story: Ellen Gibson in New York at egibson9@bloomberg.net ;

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