Wednesday, April 09, 2008

Quote of the Day:

POLITICS & POLICY

MEDICARE: Baucus To Meet With Physician Groups To Discuss Bill Senate Finance Committee aides on Monday said that Chair Max Baucus (D-Mont.) will ask more than 50 physician groups to support his Medicare bill, which would delay a scheduled 10% reduction in physician reimbursements for 18 months, CongressDaily reports. According to committee aides, Baucus will not ask the American Medical Association to support the legislation because the group opposes the mechanism that he would use to finance the delay. The $8.4 billion bill would delay the reduction in Medicare physician reimbursements, scheduled to take effect on July 1, through "balloon financing" that would result in a 21% reduction in 2010, according to CongressDaily. AMA supports a $40 billion Medicare bill sponsored by Sen. Debbie Stabenow (D-Mich.) that would increase physician reimbursements by 1.8% for 18 months and would not impose a later reduction. Stabenow said, "It's expensive," adding, "I put forward what I think is the right thing to do." Committee staffers have begun negotiations on the Baucus bill with the Bush administration, "with the hope of avoiding last year's breakdown in talks," CongressDaily reports (Johnson, CongressDaily, 4/9). Baucus on Tuesday said that the legislation, which he expects to reach the Senate floor in May, might include a reduction in Medicare Advantage plan reimbursements to help cover the cost. The Bush administration and some Republicans oppose such a reduction. Sen. Orrin Hatch (R-Utah) said, "I have no doubt they'll get some money out of Medicare Advantage, that's where some of the money is. But if it's done the wrong way and if it's too much money, it could hurt a program that has been an outstanding success" (CQ HealthBeat, 4/8). Judge Blocks Medicare Lab Competitive Bidding Program In other Medicare news, U.S. District Judge Thomas Whalen in San Diego on Tuesday issued a preliminary injunction to block the implementation of a program that would use competitive bidding to select clinical laboratories to conduct certain lab tests, the Wall Street Journal reports. Three labs have challenged the program, which CMS has launched as a pilot in the San Diego area. A CMS spokesperson had no immediate comment about the injunction (Wall Street Journal, 4/9). Hartford Courant Examines Physician Shortage The Hartford Courant on Wednesday examined how Medicare beneficiaries, as well as younger patients, often cannot find primary care physicians. According to the Courant, many primary care physicians are "overloaded" and "aren't taking new patients," with an "increasing number ... around the nation" not "accepting new patients who are on Medicare." In recent years, "far fewer medical students are choosing to enter primary care," and physicians "have complained for years" that they do not receive adequate Medicare reimbursements (Levick, Hartford Courant, 4/9).

HOUSE: Passes Brain Injury Research, Newborn Screening Bills The House on Tuesday voted 392-1 to approve a bill (S 793) that would expand research and surveillance related to traumatic brain injuries, which have become the "signature wound of the war in Iraq," the AP/Arizona Daily Star reports (Abrams, AP/Arizona Daily Star, 4/9). The legislation, which the Senate approved in December 2007, moves to President Bush for consideration. The bill would reauthorize through 2011 a CDC program that provides state grants for treatment and rehabilitation programs for patients with brain injuries (Armstrong [1], CQ Today, 4/8). The legislation also would require CDC to monitor brain injury cases, establish a reporting system and study treatment techniques, as well as require NIH to conduct basic research on treatments for brain injuries. In addition, the bill would authorize a study on efforts to improve access to care for veterans with traumatic brain injuries (AP/Arizona Daily Star, 4/9). The legislation also would reauthorize through 2011 a Health Resources and Services Administration program that provides state grants for rehabilitation programs for patients with brain injuries (Armstrong [1], CQ Today, 4/8). The Congressional Budget Office has estimated that the legislation would cost about $1.5 billion from 2008 to 2012 (AP/Arizona Daily Star, 4/9). Newborn Screening Bill The House also on Tuesday by voice vote approved a bill (S 1858) that would fund screenings for congenital, genetic and metabolic disorders in newborns, CQ Today reports. The legislation, which moves to Bush for consideration, would authorize $44.5 million in FY 2008, with small annual increases each year through FY 2012. The bill also would begin a process to establish federal guidelines for newborn screenings and authorize grants to provide states with incentives to perform such tests (Armstrong [2], CQ Today, 4/8).

GENERIC BIOTECH RX: House Committee Asks Industry for Input House Energy and Commerce Health Subcommittee leaders last week sent health industry stakeholders a six-page list of questions about how to create a pathway for FDA to approve follow-on biologics, CongressDaily reports. The request is the "first major movement on the issue" from subcommittee leaders since Chair Frank Pallone (D-N.J.) and ranking member Nathan Deal (R-Ga.) began compromise negotiations in the fall, according to CongressDaily. Other lawmakers have introduced follow-on biologics legislation, but the measures "vary wildly on how to best task FDA with approving the low-cost versions of biologic drugs," CongressDaily reports. The questions were sent by Pallone and Deal to more than 30 trade associations, big businesses, major biotechnology companies, unions and other organizations, including the Generic Pharmaceutical Association and the Biotechnology Industry Organization. The questions also were sent to FDA, the Federal Trade Commission and CMS. The questions focused on potential safety issues, market exclusivity, mandated clinical trials, interchangeability at pharmacies, patent protection and possible savings generated by follow-ons. The lawmakers wrote, "Members of the Subcommittee on Health are committed to this issue and several have introduced legislation to establish an abbreviated approval process," adding, "We have found it challenging, however, to reach consensus on a single bill that would accomplish this goal." According to the lawmakers, "In order for the subcommittee to better evaluate the merits, benefits and costs of a biosimilars bill, we wish to understand more fully the range of perspectives, concerns and objectives that might be addressed in such a legislative proposal." They added, "We are also interested as to where consensus exists within the biotechnology community and among other stakeholders." Pallone and Deal have requested responses to the questions by April 22 (Edney, CongressDaily, 4/9). Competition Can Lower Costs, Opinion Piece Says The cost of biologics can be "expected to remain high for the majority of patients who need them," unless "Congress allows monopoly-busting competition by creating a regulatory pathway for generic versions of these medicines from other manufacturers," Insmed CEO Geoffrey Allan writes in a Richmond Times-Dispatch opinion piece. According to Allan, biologics "can cost 20 times more than traditional drugs." He adds that the costs "reflect the high expenditures for research and development that go into creating these medicines, the complexity of their manufacture, the enormous patient benefit and the need for innovators to make a reasonable profit," as well as the fact that they "are sold under monopoly conditions that permit prices to remain high." According to Allan, more than $10 billion of biologics will lose their patents by 2011 with an additional $9 billion to $10 billion losing patent protection between 2012 and 2015. He continues, "The stakes for patients and their caregivers are significant." Allan writes, "Bringing competition to the current de facto monopoly will not only lower costs, but also bring competition and advancement to one of our most innovative industries" (Allan, Richmond Times-Dispatch, 4/6).

PATENTS: Rx, Biotech Industries Endorse Proposed Revisions Pharmaceutical and biotechnology executives last week endorsed proposed revisions to part of a bill (S 1145) that would reform the U.S. patent system, according to a recent e-mail written by legislation co-sponsor Sen. Orrin Hatch (R-Utah), CongressDaily reports. Among other provisions, the bill, which the technology industry has supported and the pharmaceutical and biotech industries have opposed, would require challengers who seek to invalidate patents because applicants misled the Patent and Trademark Office to prove "by clear and convincing evidence that material information was misrepresented or omitted ... with the intention of deceiving." The revisions proposed by Hatch would allow judges to return challenged patents to PTO for review and would allow the patent holder to address the issues raised by challengers during that time. Hatch said the proposed revisions would "foster open and candid interaction" between patent applicants and PTO. According to an unnamed individual in the biotech industry, the proposed revisions are "quite appealing to a lot of people" because "it's not about whether the patent applicant was a bad person" but "whether the patent is a good one or a bad one." Bill sponsor Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) likely will "unveil modifications to some controversial sections in the coming days, which could come as manager's amendments or substitute legislation," according to CongressDaily. Three senators -- Sens. Dianne Feinstein (D-Calif.), Jon Kyl (R-Ariz.) and Arlen Specter (R-Pa.) -- also have begun to draft alternative versions of the bill. Senate leaders hope to move the legislation to the floor this month. The Senate Judiciary Committee passed the bill in July 2007, and the House approved similar legislation in September 2007 (Noyes, CongressDaily, 4/7).

GINGRICH: Says Democratic Health Care Efforts Will Fail Former House Speaker Newt Gingrich (R-Ga.) on Tuesday said before an audience of hospital executives that Democrats in Congress will not be able to overhaul the U.S. health care system if they are successful in the fall elections, CQ HealthBeat reports. Gingrich is the founder of the Center for Health Transformation. Gingrich said, "On health policy, we are partly blocked down because on the House side, the two senior health people are" Energy and Commerce Committee Chair John Dingell (D-Mich.) and Ways and Means Health Subcommittee Chair Pete Stark (D-Calif.). Dingell is "a smart guy," but health care "is not a topic he has thought about much," according to Gingrich. He added that Stark, who represents the California district that includes San Francisco, "has a perfectly San Francisco attitude towards profits and towards the economy, which is that he doesn't understand why either of those is necessary and that a nice government-run bureaucracy could take care of all this." Gingrich said House members will "discover that a Dingell-Stark model of the world is not sustainable." Gingrich also said, "Those are the two guys ... plus [former House Ways and Means Committee Chair Dan] Rostenkowski [(D-Ill.)] who killed" the national health care system developed by then-first lady and current presidential candidate Sen. Hillary Rodham Clinton (D-N.Y.). He noted that, although Republican leaders at the time were willing to "cut a deal," Democrats said that "we'll never bring it up for a vote" because "[w]e would rather lose on the issue and keep talking about it than have a compromise." Both Dingell and Stark declined to comment on Gingrich's statements. Gingrich also said "there is no evidence yet" of either Clinton or presidential candidates Sens. Barack Obama (D-Ill.) or John McCain (R-Ariz.) running an issue-oriented campaign (Reichard, CQ HealthBeat, 4/8).

REGULATORY NEWS

FDA: Increases Number of Deaths Linked With Heparin FDA on Tuesday posted on the agency Web site a report that indicates the number of deaths from allergic reactions linked with the blood thinner heparin since January 2007 has increased from 19 to 62, CongressDaily reports (CongressDaily, 4/9). According to FDA officials, the agency has received 103 reports of deaths linked with heparin since January 2007, and 62 of those cases involved allergic reactions or a large decrease in blood pressure (Perrone, AP/San Francisco Chronicle, 4/9). FDA officials said that 47 of the 62 deaths linked with heparin occurred from November 2007 to February 2008 (Kaufman, Washington Post, 4/9). None of the 62 deaths linked with heparin occurred in March, the month after Baxter International recalled all batches of heparin in response to reports that linked the medication with hundreds of allergic reactions and as many as 19 deaths, according to FDA officials (Weise/Schmit, USA Today, 4/9). FDA officials found a contaminant in a number of batches of heparin manufactured by Baxter. The contaminant, which comprised 2% to 50% of the heparin in the affected batches, is a version of chondroitin sulfate -- a compound that is derived from animal cartilage and used to treat joint pain -- to which sulfur was added (American Health Line, 3/20). FDA officials said that the large increase in the number of deaths from allergic reactions linked with heparin occurred because of expanded analysis and because some health care providers and patients delayed reports to the agency (Japsen, Chicago Tribune, 4/8). Baxter Comments Baxter has received reports of 38 deaths linked with heparin. However, Baxter has identified only four deaths linked with heparin manufactured by the company (Kaufman, Washington Post, 4/9). "There are zero patient deaths known to have been caused by the allergic-type reaction" cited by FDA, according to Baxter spokesperson Erin Gardner (Mundy, Wall Street Journal, 4/9). The other reports of deaths likely resulted from heparin manufactured by other companies, other illnesses or medical conditions, or undetermined causes, Gardner said (Washington Post, 4/9). Medical Devices In related news, FDA on Wednesday sent letters to 82 medical device companies to warn them to test all products that could contain contaminated heparin. FDA spokesperson Karen Riley said, "We are aware that some of these products have been affected by the recent contaminations." She called the letters "largely a precautionary move" (Alonso-Zaldivar, Los Angeles Times, 4/9). The letters could apply to medical devices such as cardiac stents, blood oxygenators, skin expanders and equipment used in eye surgery (USA Today, 4/9). Medical device companies in some cases coat their products with heparin to prevent blood clots (Rockoff, Baltimore Sun, 4/9).

FDA: Issues Warning Letter to GSK Over Undisclosed Avandia Studies GlaxoSmithKline between 2001 and 2007 failed to properly disclose studies and clinical trials of the diabetes treatment Avandia in annual reports to FDA, according to a warning letter posted Tuesday on the agency's Web site, the Philadelphia Inquirer reports (Stark, Philadelphia Inquirer, 4/9). FDA regulators discovered the reporting discrepancies during an inspection of company documents between August and November 2007 at the U.S. headquarters of the British drug maker, Bloomberg/Chicago Tribune reports. The inspections were conducted after a study published in May 2007 in the New England Journal of Medicine found that patients who took Avandia had a 43% increased risk of heart attacks (Bloomberg/Chicago Tribune, 4/9). FDA in November 2007 announced that Avandia could remain on the market but that the label of the treatment would include a new "black box" warning about increased risk for cardiovascular events (American Health Line, 11/15/07). According to the letter, which was addressed to GSK CEO Jean-Pierre Garnier, the pharmaceutical company did not inform the agency about the launch of nine clinical trials and failed to provide updates on nearly 12 other ongoing studies, the Wall Street Journal reports (Whalen/Corbett Dooren, Wall Street Journal, 4/9). The federal agency acknowledged that information from the completed studies had been reported in prior notices before September 2007, but the failure to provide the official reports is "serious and may be symptomatic of underlying postmarket safety reporting failures," the letter said (Perrone, AP/Raleigh News & Observer, 4/9). GSK Chief Medical Officer Ronald Krall said, "We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are under way" (AP/Raleigh News & Observer, 4/9). Nancy Pekarek, a spokesperson for GSK, said the missing reports were "inadvertent omissions." Pekarek said that the company is training relevant staff so that they know "what they're supposed to report, when they're supposed to report it and how they're supposed to report it" (Wall Street Journal, 4/9).

QUALITY & COST

RETIREMENT: Health Care Costs, Economy Raise Concerns About Savings U.S. residents are becoming increasingly concerned that they will be unable to save enough money to live comfortably during their retirement as a result of rising health care costs and the slowing economy, according to the Employee Benefit Research Institute's annual survey, the AP/San Francisco Chronicle reports. For the survey, research firm Mathew Greenwald & Associates conducted telephone interviews with more than 1,320 people ages 25 and older. The survey had a margin of sampling error of plus or minus three percentage points. The survey found: 61% of respondents said they are "very confident" or "somewhat confident" of having enough money for retirement, the lowest percentage since 2001 and down from 70% in 2007; Respondents who said they are "very confident" decreased from 27% last year to 18% this year, the largest decrease in the 18-year history of the survey; 22% of respondents currently working said they are concerned about not having enough savings to cover medical expenses during retirement, while 27% are concerned about long-term care costs; 15% of retired respondents said they are worried they did not have enough savings to cover medical expenses, and 28% said they are concerned they did not have enough savings to pay for long-term care (Alt Powell, AP/San Francisco Chronicle, 4/8); 43% of respondents currently working said they are not confident they will be able to cover medical expenses in retirement, compared with 32% in 2007; 54% of respondents said they are concerned about long-term care costs, compared with 44% in 2007; 33% of respondents currently working said they expect to have access to employer-paid health insurance in retirement, compared with 41% in 2007; 41% of retired respondents said they currently have health care coverage, but 44% of those respondents said they have spent more on health care than they have budgeted (Greene, Wall Street Journal, 4/9); and About 50% of workers have saved less than $25,000 for their retirement, 24% have saved $25,000 to $99,999, 15% have saved $100,000 to $249,999 and 12% have saved $250,000 or more, not including the value of primary residences or pensions. Reaction Jack VanDerhei, a Temple University business professor and a co-author of the study, said, "I think more workers are beginning to factor in all the various information they've been given, especially the need for additional retirement funds just for the health care component" (AP/San Francisco Chronicle, 4/8). VanDerhei added that the presidential campaign likely is contributing to the results. "It's the first time in at least four years you're getting the constant drumbeat (in the media) that health expenses are going to be a problem going forward," he said, adding, "The candidates are talking about the future solvency of Medicare and employers' cutting down on retiree health coverage" (Wall Street Journal, 4/9). EBRI President Dallas Salisbury said, "The economy and health costs are major concerns," adding, "If there is a silver lining, it's that Americans finally may be waking up to the realities of being able to afford retirement" (AP/San Francisco Chronicle, 4/8). According to the St. Petersburg Times, researchers say the drop in confidence "may not be a bad thing." VanDerhei said that in the past, "people were relatively confident they'd have enough money, but if you looked at what assets they had, it was just pathetically low," adding, "The good news is that false optimism has started to evaporate. The bad news is that it hasn't translated into a lot of increased retirement savings." According to the Times, "Confidence levels have been affected by the downturn in the economy, particularly the decline in home values and stock prices and the rise in unemployment," with workers becoming "more aware of problems in their traditional safety nets." In addition, fewer workers "expect Social Security and Medicare to provide them with the same level of benefits current retirees receive," the Times reports (Huntley, St. Petersburg Times, 4/9). A brief of the survey is available online.

HIPAA: Critics, Advocates Suggest Review of Patient Privacy Law The "recent revelation" that University of California-Los Angeles Medical Center employees looked at the private medical files of high-profile and celebrity patients could prompt a review of the federal Health Insurance Portability and Accountability Act of 1996, the Los Angeles Times reports. Critics say that the law may be too lenient, particularly as more health records are being shifted to electronic systems. Since enforcement of the law began five years ago, about 34,000 reports of privacy violations have been made to the federal government, and investigations were launched into 9,000 of those reports. About 6,000 resulted in corrective measures and the rest were dismissed, according to the Times. HHS has the authority to levy civil fines on health care providers for privacy violations but has not yet done so. In addition, a Department of Justice legal opinion has stated that HIPAA applies primarily to organizations and secondarily to individuals, such as low-level clerks who are implicated in data theft most often, the Times reports. Some privacy advocates believe the law should be revised to give patients the ability to specify who can and cannot access their private medical information, but others in the industry say that would be difficult to enforce. Some federal officials "say they believe that implementation of the law strikes a balance between education and enforcement," according to the Times. Robinsue Frohboese -- principal deputy director of HHS' Office for Civil Rights, which investigates reported privacy violations -- said, "Where we have found noncompliance, we have been able to get systemic change that benefits all individuals." Frohboese added that health care providers and insurers have had to retrain their staff, modify their technology and adopt other privacy protection measures (Alonso-Zaldivar, Los Angeles Times, 4/9).

INSIDE THE INDUSTRY

NAVIGENICS: Releases New At-Home Genetic Test for 18 Diseases Navigenics on Tuesday released a new at-home genetic test that can determine whether consumers have increased risk for 18 diseases, the Wall Street Journal reports (Wang, Wall Street Journal, 4/8). The Health Compass test costs between $2,500 and $3,000, and health insurers do not cover the cost. For the test, consumers collect a saliva sample in a vial and mail the sample to Navigenics for analysis. Navigenics said that consumers can use the results of the tests to determine whether they should change their lifestyles to help reduce risk for diseases (Hurley, New York Post, 4/8). Navigenics has established standards to ensure the accuracy and privacy of the results of the test, as well as access to genetic counselors for consumers who seek them. In addition, Navigenics plans to conduct long-term, follow-up studies to determine the reaction of consumers after they receive the results of the test. According to the Journal, some experts have raised concerns about the accuracy of at-home genetic tests, the lack of government oversight of companies that market such tests and "whether consumers know what to do" with the results. Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, said that the scientific community will have to review the standards established by Navigenics and that the company will have to demonstrate compliance to consumers (Wall Street Journal, 4/8).

RX DRUGS: WSJ Examines Concerns About Origins of Medications The Wall Street Journal on Tuesday examined how "some consumers -- and even some physicians -- are asking" about the lack of country-of-origin information on the labels of medications. Concerns about the issue have increased after FDA last month linked hundreds of allergic reactions and as many as 19 deaths to batches of the blood thinner heparin manufactured in China. According to the Journal, "FDA requires drug companies to disclose only the name and place of business of the manufacturer, packer or distributor of prescription medications," and active and inactive ingredients "must be listed on the label, but not the raw materials or their origins." In addition, medications might "include dozens of fillers and bulking agents, each of which has its own global supply chain," the Journal reports. Pharmaceutical companies maintain that the disclosure of such information would not benefit consumers and that any medications marketed in the U.S. must meet Good Manufacturing Practices established by FDA. However, "ensuring that those rules are met is up to the companies," as FDA "doesn't have the resources to regularly inspect oversees facilities," where 80% of the active ingredients for medications marketed in the U.S. originate, according to the Journal. In response, the House Energy and Commerce Committee has begun to consider a bill that would require medication labels to list the country of origin for active ingredients (Beck, Wall Street Journal, 4/8).

PROVIDER NEWS

RETAIL HEALTH CLINICS: Number Growing at U.S. Airports More retail health clinics and pharmacies are opening at U.S. airports in an attempt to "capture a sizable portion of travelers and airport employees who want access to basic primary health care and to fill their prescriptions," USA Today reports. Such facilities are more common at large foreign airports, as U.S. airports tend to focus more on travelers' immediate needs. However, a few factors are boosting the number of airport clinics and pharmacies. According to USA Today, airports are increasingly searching for nonaviation revenue to offset the discounts and promotions they offer to airlines to court new flights. In addition, tighter security procedures at airports have increased the waiting time for passengers, which gives them adequate time to seek basic health services. Tine Hansen-Turton, executive director of the Convenient Care Association, a trade group for retail walk-in clinics, said, "Airports lend themselves as an ideal market for retail-based care because (there are) a lot of people in between flights or who have downtime," adding, "You also have employers who have hours not conducive to going to primary care providers" (Yu, USA Today, 4/8).

RESEARCH NOTES

ALZHEIMER'S: AHL Examines Recent Studies Summaries of studies related to Alzheimer's disease appear below. Antipsychotics: Antipsychotic drugs used to treat aggression in Alzheimer's patients living in nursing homes provide no benefit and might lead to a significant decline in verbal ability, according to a study published in the Public Library of Science, USA Today reports. For the study, Oxford University researchers led by geriatric psychiatrist Robin Jacoby examined 165 people with severe Alzheimer's living in nursing homes in four cities in Great Britain. The patients had been taking an antipsychotic drug for at least three months. The researchers replaced the medications of half of the patients with a placebo, and the other half of patients continued taking the drugs. After six months, researchers found that patients taking the antipsychotics showed a significant deterioration in their ability to speak fluently. Although the disease ultimately destroys the brain's language centers, the study concluded that the drugs might speed up the process. Antipsychotics are approved for the treatment of schizophrenia but can be prescribed "off-label" for Alzheimer's patients (Fackelmann, USA Today, 4/8). The study is available online. Depression: People with depression are more likely to develop Alzheimer's later in life, according to a study published in the Archives of General Psychiatry, Reuters reports. A team led by Robert Wilson, a neuropsychologist at Rush University Medical Center, tracked 917 retired Catholic priests and nuns, 190 of whom developed Alzheimer's. Those with symptoms of depression at the beginning of the study were more likely to develop the disease. However, researchers did not find a sudden onset or worsening of depression in subjects in the few years before the symptoms of the disease became apparent. The results suggested that "depression truly is a risk factor" for the disease, rather than "simply a sign that the disease is developing," Wilson said. He added, "Our thinking is that depression somehow causes damage to part of the brain called the limbic system, and this is the part of the brain that Alzheimer's disease preferentially attacks" (Reuters, 4/7). An abstract of the study is available online.

RARE DISEASES: Research 'Struggling' Under Tight Federal Budgets The AP/Albany Times Union on Monday examined how a dearth of funding has affected research into rare diseases. According to the AP/Times Union, a recent report found NIH's budget "has been essentially flat since 2003," which is equivalent to a 13% reduction when accounting for medical inflation. As a result, 3,000 fewer patients were enrolled in clinical trials run by NIH's cancer network in 2007, according to Allen Lichter of the American Society for Clinical Oncology. According to the AP/Times Union, Merkel cell carcinoma offers "a poignant glimpse of the desperate intersection of research dollars and the suffering wrought by rare diseases." Merkel cell carcinoma is an "aggressive" type of cancer that spreads quickly and kills about one-third of patients within three years. Since 15 years ago, when Merkel cell carcinoma was recognized as distinct from melanoma and as needing a specific kind of treatment, the number of new cases of the cancer has grown three times to about 1,500 annually. However, there have been no well-controlled studies of the best treatment, according to the AP/Times Union. Paul Nghiem, a Merkel cell expert at the University of Washington, said that for the past 20 years, research into Merkel cells has been dependent on small-scale pilot grants and fundraising efforts by patients' families. Last week, Nghiem was awarded a research grant worth $840,000 from the American Cancer Society, believed to be the largest-ever research grant for Merkel cell carcinoma (Neergaard, AP/Albany Times Union, 4/7).

TRENDS & TIMELINES

RED CROSS: Business 'Veteran' McGovern Named as CEO The American Red Cross on Tuesday named Gail McGovern, a professor at Harvard Business School and former business executive, as the organization's seventh president and CEO since 2002, the New York Times reports. McGovern will replace Mark Everson, who was ousted in November 2007 (Strom, New York Times, 4/9). Since November, Mary Elcano has led the organization on an interim basis and will return to her posts as general counsel and corporate secretary when McGovern takes over on June 23 (Crary, AP/Wall Street Journal, 4/9). McGovern will receive a salary of $500,000, plus a $65,000 signing bonus. She was unanimously chosen by the Red Cross' board of governors from a pool of 170 candidates because of her financial acumen and her commitment to not-for-profit organizations, according to board Chair Bonnie McElveen-Hunter (Rucker, Washington Post, 4/9). McGovern from 1974 until 1998 worked at AT&T, rising from a computer programmer to executive vice president of the consumer-markets division. She then joined Fidelity Investments, overseeing a unit serving four million customers with $500 billion in assets, before joining the faculty at Harvard Business School in 2002 (AP/Wall Street Journal, 4/9). According to the Times, she has no biomedical or manufacturing background (New York Times, 4/9). She also "has done little work in the primary mission of the Red Cross: disaster relief," according to the Washington Post. McGovern said, "One of the reasons I'm attracted to the position is that it does have challenges, and I'm hoping that I can bring my background and experience to the organization and help lead us to financial stability and growth," adding that bolstering fundraising is among her top priorities (Washington Post, 4/9).

OBESITY: AHL Highlights Recent Developments Summaries of several recent developments related to obesity and nutrition appear below. Ambulance equipment: The New York Times on Tuesday examined how as "obesity rates increase around the country, fire departments and emergency medical workers" are beginning to invest in emergency medical equipment that can support heavier patients. According to the Times, equipment capable of transporting heavier patients "can be expensive." A bariatric cot can cost around $4,000, four times the cost of a standard cot. Doug Moore, a spokesperson for ambulance operator American Medical Response, said a bariatric ambulance that can support patients up to 1,000 pounds costs $110,000 to build, compared with $70,000 for a standard ambulance (Zezima, New York Times, 4/8). Chain restaurants: Sen. Tom Harkin (D-Iowa) has introduced a bill (S 2784) that would require chain restaurants to disclose nutritional information, CQ HealthBeat reports. The bill, which would apply to restaurants with 20 or more locations under the same name, would require them to list the number of calories, grams of saturated and trans fats, and milligrams of sodium for regular menu items. The measure would exclude temporary or special menu items. Rep. Rosa DeLauro (D-Conn.) has introduced a companion bill (HR 3895) in the House (Cooley, CQ HealthBeat, 4/4). Infants: Children who sleep less than 12 hours daily are more likely than children who get more sleep to be overweight by age three, according to a report published on Monday in the journal Archives of Pediatrics & Adolescent Medicine, the St. Petersburg Times reports (Greene, St. Petersburg Times, 4/7). Lead researcher Elsie Taveras of Harvard Medical School and colleagues surveyed mothers of 915 children up to age two regarding sleep, television viewing patterns and weight. They found that 586 of the children slept an average of 12 hours daily and that 329 of the children slept less. Among those who slept longer than 12 hours, 7% were obese by age three, compared with 12% for those who slept less. The study also found that 17% of the children who slept less than 12 hours per day and watched two or more hours of television were obese by three years old (Johnson, AP/Chicago Tribune, 4/7). An abstract of the study is available online. New York City: The rate of obesity and diabetes is rising faster in New York City than the rest of the U.S., according to a study published in the April issue of the journal Preventing Chronic Disease, the AP/Boston Globe reports. Researchers from the New York City Department of Health and Mental Hygiene examined data from the Community Health Survey, a telephone survey of 10,000 New York City adults, and from the Behavioral Risk Factor Surveillance System, a similar study conducted nationwide. They found New York City's obesity and diabetes rates each increased by 17% between 2002 and 2004, compared with a 6% increase nationally for obesity, while national diabetes rates remained at 7% (AP/Boston Globe 4/7). An abstract of the study is available online. Philadelphia: Half the number of students became obese in five Philadelphia elementary schools that participated in a weight-loss and exercise program than students in elementary schools that did not make any changes, according to a study published in the April issue of Pediatrics, the AP/ Globe reports. The study followed 1,349 Philadelphia students in grades four through six. At the schools participating in the program, healthier options were inserted into school vending machines; snacks were required to meet limits for fat, salt and sugar; and students who ate "healthy snacks" received raffle tickets to win prizes. In addition, students at the five schools received nutrition lessons, were urged to exercise during recess and were measured and weighed periodically. The number of overweight children at the five schools dropped to 15%, a decrease of about 10%, by the end of the two-year study. Meanwhile, the number of overweight children increased to 20%, a 25% increase, at the schools that did not make any changes. Forty percent of all the students in the study were overweight at the beginning of the study. By the end, 7% became overweight at the five participating schools, compared to 15% in schools that did not make any changes (Nano, AP/Boston Globe, 4/7). Women: Women with waists measuring 35 inches or greater have an 80% higher risk of dying prematurely than women whose waists are 28 inches or smaller, according to a study published Monday in the journal Circulation, the Seattle Times reports. The study, conducted by researchers from Harvard University and Brigham and Women's Hospital, found that women with the largest waists had twice the risk of dying of cardiovascular disease, even if their weight was normal, and a 63% increased chance of dying from cancer compared with women with smaller waists (Seattle Times, 4/8).

PULITZERS: Newspapers Receive Prizes for Health Care Stories Several newspapers on Monday received Pulitzer Prizes for reporting on health care and medical issues, the AP/Minneapolis Star Tribune reports. Washington Post reporters Dana Priest and Anne Hull received a Pulitzer for public service for a series on problems with living conditions and medical services for veterans at Walter Reed Army Medical Center. According to the AP/Star Tribune, the series "caused a national outcry and led to the firing of the Army secretary" and the establishment of a presidential commission to address the problems. New York Times reporters Walt Bogdanich and Jake Hooker received a Pulitzer for investigative reporting on toxic ingredients in medications and other products imported from China, and Times reporter Amy Harmon received a prize for explanatory reporting on ethical issues related to DNA tests. In addition, Concord Monitor photographer Preston Gannaway received a Pulitzer for feature photography for a series of pictures that chronicled the family of a parent with a terminal illness. Columbia University awards Pulitzers based on the recommendations of an 18-member Pulitzer board, and recipients, except for winners of the prize for public service, receive $10,000 (Hajela, AP/Minneapolis Star Tribune, 4/7).

OPINIONMAKERS

ECONOMY: Increased Health Care Costs Contribute to Wage Slowdown The current wage slowdown in the U.S. has a number of causes and has "been building for a long time," and in recent years, the "cost of health care has aggravated the problem by taking a huge bite out of most workers' paychecks," columnist David Leonhardt writes in the New York Times. According to Leonhardt, a "serious effort to curtail wasteful medical spending would directly help workers" and "spare them from paying the insurance premiums and taxes that cover that care." Leonhardt writes that, based on a conversation with Ezekiel Emanuel of NIH, a "serious effort to curtail wasteful medical spending would directly help workers" and "spare them from paying the insurance premiums and taxes that cover that care." He recommends "job-creating investments in biomedical research" and other areas and writes that presidential candidates Sens. Hillary Rodham Clinton (D-N.Y.), Barack Obama (D-Ill.) and John McCain (R-Ariz.) have discussed similar proposals. However, "there is still a lack of strategic seriousness to the discussion," he writes. Leonhardt concludes that, because the economy "seems to be in recession, and recessions inevitably bring their own pay cuts, my guess is that the problem will look even bigger by the time the next president takes office" (Leonhardt, New York Times, 4/9).