molly-peterson

Novartis MS Pill’s Risks May Outweigh Benefits as FDA Advisers Review Drug

by on June 8, 2010

By Elizabeth Lopatto and Molly Peterson June 8 (Bloomberg) — Novartis AG ’s drug Gilenia has risks that may outweigh its benefit in treating multiple sclerosis, according to U.S. regulators reviewing whether to approve the first pill to slow progression of the disease. Gilenia, while effective, causes a gradual decline in lung function and is linked to certain cancers, Food and Drug Administration staff said in a review today. Outside advisers to the FDA will meet June 10 to recommend whether the drug, also called fingolimod , should be approved for sale. Novartis, of Basel, Switzerland, is racing German drugmaker Merck KGaA to sell the first pill to stall MS, competing with injected remedies led by Biogen Idec Inc.’s Avonex. The FDA has said it will complete its review by September. Gilenia may go on sale in 2010 and reap $1 billion a year, Novartis has said. “The pivotal efficacy studies provide robust evidence of the efficacy of fingolimod to reduce the frequency of clinical exacerbations in patients with relapsing remitting MS,” FDA staff said in the report. “The clinical development program also uncovered a number of safety issues, which will be the primary focus for the advisory committee meeting.” Skin cancer and heart risks will probably fuel a “vigorous debate” at the panel meeting, Yaron Werber , an analyst for Citibank in New York, said June 4 in a research note. Those risks were linked to the treatment in a study published in January in the New England Journal of Medicine, and also identified as adverse events in the FDA review today. Novartis fell 35 centimes, or 0.7 percent, to 52.05 Swiss francs at 2:35 p.m. local time in Zurich trading. More Information The FDA may ask for more information on Gilenia in September instead of clearing it, a move that would delay approval until the end of 2011, Werber said. “A positive recommendation is far from certain and, even if the panel does give a positive vote, the FDA’s recent track record has become somewhat less predictable,” Werber said. Global sales of Gilenia may reach $780 million in 2014, he said. The FDA rejected Merck’s application for rival pill cladribine in November, saying it was incomplete. Merck, based in Darmstadt, Germany, said today it resubmitted the drug for U.S. approval. Multiple sclerosis affects about 2.5 million people, according to the National Multiple Sclerosis Society in the U.S., causing the body to attack itself through the immune system. Immune System Gilenia and cladribine both blunt the immune system’s attack on nerve cells. Cladribine was approved more than a decade ago to fight leukemia; both it and Gilenia target certain white blood cells that are part of multiple sclerosis’s attack on the protective coating of nerve cells. Acorda Therapeutics Inc. ’s pill to improve walking in multiple sclerosis patients was approved by U.S. regulators in January, the first therapy of its kind cleared for sale. The pill, which is co-promoted with Biogen, doesn’t treat the underlying disease. Doctors also often prescribe oral corticosteroids to damp the immune system’s effects during acute attacks; they don’t affect the underlying disease either. Novartis and Mitsubishi Tanabe Pharma Corp. will develop and sell fingolimod together in Japan, said Takayuki Ikeda, a spokesman for the Osaka-based drugmaker. Novartis bought overseas rights in September 1997 to the medicine, discovered in research involving Mitsubishi Tanabe’s predecessor company, Ikeda said. To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net ; Molly Peterson in Washington at mpeterson9@bloomberg.net

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Novartis MS Pill’s Risks May Outweigh Benefits as FDA Advisers Review Drug

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

by on June 4, 2010

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

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

Sodium Ranks Near Tobacco as Health Risk Possibly Needing U.S. Regulation

March 2, 2010

By Molly Peterson March 2 (Bloomberg) — The food industry may face sodium limits from the U.S. government if it doesn’t voluntarily reduce salt content in processed foods, said Thomas Frieden , director of the Centers for Disease Control and Prevention. “Substantial changes” in food production are needed to improve Americans’ health by reducing salt consumption, Frieden, who previously headed New York City’s health department, said in an editorial published in the Annals of Internal Medicine . A voluntary reduction of salt by food manufacturers would lower consumption more than a mandatory tax on salt in packaged foods, according to a study in the same journal that Frieden cited. American adults consume an estimated 3,900 milligrams of sodium per day — more than twice the maximum recommended by U.S. government dietary guidelines, according to a Stanford University study published in the same journal. Excess sodium intake is linked to high blood pressure, raising the risk of heart attacks and stroke, Frieden said in yesterday’s editorial . “Because more than three-fourths of Americans’ sodium intake comes from processed foods and restaurant meals, it is extremely difficult for individuals to limit their consumption to healthy levels,” Frieden said. If foodmakers don’t make those foods less salty, “new regulations on sodium content of processed and prepared foods might be necessary.” The industry already is working to help Americans lower their sodium intake, said Melissa Musiker, senior manager of science policy, nutrition and health at the Grocery Manufacturers of America . Campbell Soup Co ., the world’s largest soupmaker, and Hormel Foods Corp. are two of the Washington- based group’s members that have announced voluntary sodium reductions. The group represents more than 200 food and beverage makers. Groundwork Frieden laid the groundwork for New York’s push to reduce salt in prepared foods before President Barack Obama picked him last year to head the Atlanta-based CDC. He also banned smoking and trans fats in the city’s restaurants during his seven years as health commissioner. New York announced an effort in January to spur food makers and restaurant chains to voluntarily reduce their salt use by 25 percent over five years. Americans’ sodium consumption may be reduced 9.5 percent if U.S. regulators emulated a U.K. initiative by working with the industry to cut salt in packaged foods, the Stanford study found. That would lead to decreases in blood pressure preventing more than 513,000 strokes and more than 480,000 heart attacks among Americans ages 40 to 85, and save $32 billion in medical costs, according to the report also published yesterday in the Annuals. Voluntary Effort Food manufacturers “have been working voluntarily, often without the consumer’s knowledge, on the reduction of sodium, and they plan to continue doing so,” Musiker said yesterday in an interview. Camden, New Jersey-based Campbell says it has more than quadrupled its lower sodium offerings to more than 110 products from 25 in 2005. The company reduced sodium in more than 90 soups, including its condensed tomato soup and V8 vegetable juice drinks, according to a Jan. 11 statement. ConAgra Foods Inc. , based in Omaha, Nebraska, said in 2007 that its voluntary initiative to cut sodium from products such as Marie Callender’s frozen dinners, Orville Redenbacher’s popcorn and Chef Boyardee canned ravioli had removed about 2.8 million pounds from Americans’ diets annually. Austin, Minnesota-based Hormel , the maker of Spam luncheon meat and Jennie-O turkey, has said it cut more than 560,000 pounds of salt from its products in 2007 and an additional 438,738 pounds in 2008. ‘Sodium Tax’ Levying a “sodium tax” could decrease U.S. sodium consumption by another percent and save $22.4 billion in medical costs, the study found. No country has imposed such a tax, according to the report. “After tobacco control, the most cost-effective intervention to control chronic diseases might be reduction of sodium intake,” Frieden said in the editorial, written with Peter Briss, the CDC’s acting associate director for science. The U.K.’s sodium campaign , which includes voluntary salt- reduction targets for the food industry, helped inspire the study, said Crystal Smith-Spangler, the lead author of the research article. “Based on our data, it looks like it could be worth doing because it’s very cheap and because cardiovascular disease is such a huge problem and hypertension is such a major risk factor for cardiovascular disease,” Smith-Spangler, a postdoctoral scholar at Stanford’s Center for Health Policy , said yesterday in an e-mail. Long-Term Study The government should conduct a long-term study of the health benefits of a low-sodium diet before “trying it out on the public,” said Dick Hanneman, president of the Salt Institute in Alexandria, Virginia. The group represents salt producers such as Chicago-based Morton Salt, a unit of Dow Chemical Co. “There’s good scientific evidence that calls into question Dr. Frieden’s conclusions,” Hanneman said yesterday in an interview. “We think the next responsible step is to do a health outcome study of low-sodium diets and also, at this point, to study whether sodium appetite can be modified over a long term.” To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

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`Out of Whack’ U.S. College Tuitions May Drive Students Away, Duncan Says

August 21, 2009

By Molly Peterson Aug. 21 (Bloomberg) — Private colleges may price themselves out of the market if they don’t hold down tuition increases, U.S. Education Secretary Arne Duncan said. Parents and students will choose among universities offering “no-frill campuses” and three-year degree programs over those whose prices “get out of whack with reality,” Duncan said in an interview on Bloomberg Television’s “Political Capital With Al Hunt ,” airing today. The average tuition at private four-year colleges increased 5.9 percent to $25,143 in the 2008-2009 school year, according to the New York-based College Board . “At a time when going to college has never been more important, it’s never been more expensive,” Duncan said. Private colleges raised tuition an average of 4.2 percent for the coming school year, the smallest increase in 37 years, said Tony Pals, a spokesman for the National Association of Independent Colleges and Universities , a Washington-based lobbying group that represents 955 schools. Duncan, 44, the former head of Chicago’s public schools, is using $100 billion in stimulus funds as leverage to reshape U.S. education. More than $30 billion is for higher education, with most of the rest going to public education in kindergarten through high school. ‘Dramatic’ Reforms States should use the stimulus money to spur “dramatic” public-school reforms that will improve teacher quality, raise academic standards, transform failing schools and improve data systems to track student progress, Duncan said. “This money will be gone over the next two, three, four years,” Duncan said. “We’re trying to push, with this money, the kind of reform that will last for the next several decades.” More than $55 billion of the $100 billion had been allocated as of Aug. 14, and $13.6 billion had been paid out, Education Department spokesman Justin Hamilton said yesterday in an e-mail. Some of the money is being used to prod school districts to set a “very high bar” for charter schools and hold them accountable for student performance, Duncan said. Charter schools operate under contracts with districts and are exempt from many rules that govern traditional public schools. “When you pick the best of the best, when you give them clear autonomy and clear accountability, we’re seeing great things happen,” Duncan said of charter schools. Teacher Pay Duncan and President Barack Obama also are pushing schools to link student achievement to teacher pay. States barring the use of student-performance data in teacher evaluations would be ineligible for $4.35 billion in competitive stimulus grants, known as Race to the Top funds, under guidelines Duncan and Obama proposed last month. “Somehow in education, we’ve been scared to talk about excellence,” Duncan said. “I think that has to change.” Most of the education money will go to states under a noncompetitive formula set in the stimulus legislation. Duncan said he’ll award the competitive grants, including Race to the Top, to “a relatively small number of states and districts that are going to lead the country where we need to go.” Former House Speaker Newt Gingrich , a Republican, and Reverend Al Sharpton , a Democrat, plan to join Duncan, starting next month, on a tour of four cities to field suggestions for improving U.S. schools. “Quite a team, isn’t it?” Duncan said. “If there is anything, as a country, we can come together behind in a non- ideological manner, it’s behind education.” College Graduation Obama has called for the U.S. to have the world’s highest percentage of college graduates by 2020. The administration will fund initiatives to help more students finish college in addition to programs that help them afford it, Duncan said. Most private four-year colleges will meet their enrollment goals for the coming school year, in part because the Obama administration has increased federal financial aid, Pals said. “Students continue to vote with their feet and our institutions have maintained their market share over past 20 years,” Pals said. Information technology and insurance, including student health care, are the fastest-growing costs driving up tuition, he said. Duncan, a former Harvard University basketball player, partially ducked a question about college football’s championship system. Duncan noted that Obama has said the National Collegiate Athletic Association should replace the Bowl Championship Series with a playoff system to determine the national champion. “I’m not the expert on this,” Duncan said. “I know the president thinks they should, so I think I’ll follow the president.” To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

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Three American Troops, One French Soldier Killed in Attacks in Afghanistan

August 1, 2009

By Molly Peterson Aug.

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