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"In Bethesda, MD, in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case. A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves. The results were stunning. Within three months, the rate of bloodstream infections from these IV lines fell by two-thirds. The average ICU cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million. Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island. The government's decision was bizarre and dangerous. But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist."

Gawande A. New York Times. December 30, 2007



"Starting in 2009, every child born in Maine will be eligible for $500 toward college from the fortune of a shoe magnate who died there last month. The benefactor, Harold Alfond, who founded the Dexter Shoe Company in Dexter, ME, arranged for his philanthropic foundation to give out the grants. Parents of newborns will receive applications to open a tax-free college savings account with the money before leaving the hospital. Mr. Alfond, who never went to college, sold Dexter Shoe to Berkshire Hathaway, Warren E. Buffett's holding company, for more than $400 million in 1993. He was one of Maine's leading philanthropists, donating more than $100 million to the University of Maine and other institutions around the state. His posthumous project, the Harold Alfond College Challenge, 'will serve to raise the aspirations and opportunities of countless Maine children,?Gov. John Baldacci said in a statement. About 14,000 babies were born in Maine last year. If that number holds steady, the foundation could spend as much as $7 million a year on the effort. The Finance Authority of Maine, which will administer the program, estimated that with no additional contribution, each $500 account could grow to $2,000 by 2026. But Mr. Alfond hoped that parents would contribute more, and foundation officials said adding $50 a month to an account could increase its value to $25,000 over the same period. 'His concept of philanthropy was that if you can encourage people to invest alongside you,' said Greg Powell, the foundation's chairman, 'the gift will have more meaning and a greater impact.'"

Goodnough A. New York Times. December 12, 2007


"It's time to rein in the test zealots who have gotten such a stranglehold on the public schools in the US. Politicians and others have promoted highstakes testing as a panacea that would bring accountability to teaching and substantially boost the classroom performance of students. 'Measuring,' said President Bush, in a discussion of his No Child Left Behind law, 'is the gateway to success.' Not only has high-stakes testing largely failed to magically swing open the gates to successful learning, it is questionable in many cases whether the tests themselves are anything more than a shell game. Daniel Koretz, a professor at Harvard's Graduate School of Education, told me in a recent interview that it's important to ask 'whether you can trust improvements in test scores when you are holding people accountable for the tests.' The short answer, he said, is no. If teachers, administrators, politicians and others have a stake in raising the test scores of students--as opposed to improving student learning, which is not the same thing--there are all kinds of incentives to raise those scores by any means necessary. 'We've now had four or five different waves of educational reform,' said Dr. Koretz, 'that were based on the idea that if we can just get a good test in place and beat people up to raise scores, kids will learn more. That's really what No Child Left Behind is.' The problem is that you can raise scores the hard way by teaching more effectively and getting the students to work harder, or you can take shortcuts and start figuring out ways, as Dr. Koretz put it, to 'game' the system. Guess what's been happening? 'We've had high-stakes testing, really, since the 1970s in some states,' said Dr. Koretz. 'We've had maybe six good studies that ask: "If the scores go up, can we believe them? Or are people taking shortcuts?" And all of those studies found really substantial inflation of test scores.'"

Herbert B. New York Times. October 9, 2007



"Nearly 19,000 people died in the United States in 2005 after being infected with virulent drug-resistant bacteria that have spread rampantly through hospitals and nursing homes, according to the most thorough study of the disease's prevalence ever conducted. The government study, which is being published on Wednesday in The Journal of the American Medical Association, suggests that such infections may be twice as common as previously thought, according to its lead author, Dr. R. Monina Klevens. If the mortality estimates are correct, the number of deaths associated with the germ, methicillinresistant Staphylococcus aureus, or MRSA, would exceed those attributed to HIV-AIDS, Parkinson's disease, emphysema or homicide each year. By extrapolating data collected in nine places, the researchers estimated that 94,360 patients developed an invasive infection from the pathogen in 2005 and that nearly one of every five, or 18,650 of them, died. The study points out that it is not always possible to determine whether a death is caused by MRSA or merely accelerated by it. The authors, who work for the Centers for Disease Control and Prevention, cautioned that their methodology differed significantly from previous studies and that direct comparisons were therefore risky. But they said they were surprised by the prevalence of serious infections, which they calculated as 32 cases per 100,000 people."

New York Times. October 16, 2007



"Why do so many passengers get off the plane only to discover that their baggage did not make the trip with them? American Airlines started asking that question with greater urgency a year ago, and its search for answers led to, among other problems, dirty printer heads. Workers at American found that printers that produce adhesive tags for bags were often dirty. That made bar codes hard to read, leading to misdirected bags. Regular wiping of the printer heads helped, but even with a clean printer, the bar code readers are only about 90 to 92 percent accurate, said Denise P. Wilewski, manager of airport services for American here [in Chicago]. 'We never hit 100 percent --90 percent is acceptable,' she said."

Bailey J. New York Times. November 21, 2007


"A handful of high-cost and high-volume conditions helped drive the national hospital bill up 7% in 2005, to $873 billion, a record high and nearly double 1997 spending adjusted for inflation, a federal agency reported. The report, from the federal Agency for Health Care Research and Quality, analyzed figures from the most recent year available and found in part that triple-digit percentage growth in the amount charged for blood infections, nonspecific chest pain, respiratory failure, back pain and arthritis over the past decade contributed to the increase. The five costliest categories were coronary-artery disease, pregnancy and delivery, newborn-infant care, heart attack and congestive heart failure, followed by pneumonia and arthritis. So while overall charges rose 89% since 1997, sepsis charges rose 183% and chest-pain billing--where no specific cause could be found--rose 181%. Some of the costliest conditions showed slower growth: Newborn-care charges grew 78%, while general rehabilitation and pregnancy care rose by 77% and 75%, respectively."

Wall Street Journal. December 13, 2007


“The world’s most promising malaria vaccine has been shown to work in infants less than a year old, the most vulnerable group, according to a study being published today. The study, being published in The Lancet, a British medical journal, was small, comprising only 214 babies in Mozambique, and intended to show only that the vaccine was safe at such young ages. But it also indicated that the risk of catching malaria was reduced by 65 percent after the full course of three shots. ‘We’re now a step closer to the realization of a vaccine that can protect African infants,’ said Dr. Pedro Alonso, the University of Barcelona professor who leads clinical trials of the GlaxoSmith-Kline vaccine. If it passes much larger clinical trials set to start in seven countries next year, and if it is accepted by national regulatory agencies, it could be ready for distribution by 2012, said Dr. W. Ripley Ballou, Glaxo’s vice president for international clinical trials. In 2004, Dr. Alonso showed for the first time that the vaccine could protect children against infection or death. That study of 2,022 children aged 1 to 4 showed protection from infection about 45 percent of the time. Such a relatively low level of protection would not be acceptable in a vaccine in the West, but malaria is a leading killer of African children, so even imperfect coverage is a major public health victory.”

New York Times. October 18, 2007



"Next month, the Union City (NJ) district will give out 300 iPods at its schools as part of a $130,000 experiment in one of New Jersey's poorest urban school systems. The effort has spurred a handful of other districts in the state, including the ones in Perth Amboy and South Brunswick, to start their own iPod programs in the last year, and the project has drawn the attention of educators from Westchester County to Monrovia, CA. The spread of iPods into classrooms comes at a time when many school districts across the country have outlawed the portable players from their buildings----along with cellphones and DVD players----because they pose a distraction, or worse, to students. In some cases, students have been caught cheating on tests by loading answers, mathematical formulas and notes onto their iPods. But some schools are rethinking the iPod bans as they try to co-opt the devices for educational purposes. Pedro Noguera, a sociology professor at New York University who studies urban schools, said that more districts were using new technologies like iPods to connect with students. For instance, he said, teachers have designed video games around history lessons and assigned students to re-enact novels and plays on YouTube. 'You know the No. 1 complaint about school is that it's boring because the traditional way it's taught relies on passive learning,' Mr. Noguera said. 'It's not interactive enough.' In many affluent communities, iPods have evolved into an essential accessory for students. In 2004, Duke University led the way by outfitting its entire freshman class with iPods that were preloaded with orientation information and even the Duke fight song. [Some] Spanish-speaking students----known around the school as Pod People----have been able to move out of bilingual classes after just a year of using the digital devices, compared with an average of four to six years for most bilingual students."

New York Times. October 8, 2007



"Across Japan, more than one million men and boys have chosen to withdraw completely from society. These recluses hide in their homes for months or years at a time, refusing to leave the protective walls of their bedrooms. They are as frightened as small children abandoned in a dark forest. Some spend their days playing video games. A few--an estimated 10 percent--surf the Internet. These men are called hikikomori, which translates loosely as one who shuts himself away and becomes socially withdrawn. (The Japanese word joins together the word hiku or 'Pull,' with the word komoru, or 'retire,' to render the meaning 'Pulling in and retiring.' These men--and 80% of hikikomori are males--cannot be diagnosed as schizophrenics or mental defectives. They are not depressives or psychotics; nor are they classic agoraphobics, who fear public spaces but welcome friends into their own homes. When psychiatrists evaluate the hikikomori using the Diagnostic and Statistical Manual, or DSM IV, the standard guide used in the West to diagnose mental disorders, their symptoms cannot be attributed to any known psychiatric ailment. Instead, Japanese psychiatrists say that hikikomori is a social disorder, only recently observed, that cannot be found within other cultures. These men--as I found during months of conversations with them--are often intelligent, stimulating, highly open and responsive adults full of cogent ideas and fascinating insights into society and themselves."

Shutting Out the Sun: How Japan Created Its Own Lost Generation. Nan A.
Talese, an imprint of Doubleday, a division of Random House, Inc. 2006



"Four of the nation's biggest makers of artificial hips and knees have agreed to pay a total of $310 million in penalties to settle federal accusations that they used fake consulting agreements and other tactics to get surgeons to use their products. Under the settlements, which were announced yesterday by the United States attorney in Newark, the four companies were charged with criminal conspiracy to violate anti-kickback laws. But they will not be prosecuted if they follow new compliance procedures under federal monitoring for 18 months. 'This industry routinely violated anti-kickback statutes by paying physicians for the purpose of exclusively using their products,' said Christopher J. Christie, the United States attorney in Newark. 'Prior to our investigation, many orthopedic surgeons in this country made decisions predicated on how much money they could make--hoosing which device to implant by going to the highest bidder.' A fifth big maker of orthopedic devices. . .accepted federal supervision for 18 months, but the Justice Department agreed not to file criminal charges because [it] was the first company to cooperate in the investigation, according to the government. The company admitted no wrongdoing. The government said the five companies represented 95 percent of the hip and knee implant market. The settlements allow the companies to continue to enter into product development agreements with doctors that reward them with royalties based on future sales. But the companies will be required to pay for consulting and other services on an hourly basis, with a cap of $500 an hour."

New York Times, September 30, 2007


32. "In the past, the real advances in medicine have often come not from research specifically directed against a target but rather from discoveries made in fields other than the one being studied. In cancer, chemotherapy arose from the development of instruments of chemical warfare, the study of nutritional disease, and the effect of electric current on bacterial growth. A major tumor-suppressor gene was discovered through research on polio vaccines. Stem cells were discovered through research on bone-marrow transplants for leukemia and for whole-body irradiation from nuclear weapons. Agents for alteration of mood and behavior came from attempts to combat surgical shock, the treatment of tuberculosis, and the search for antibiotics. When scientists were allowed to pursue whatever they found, serendipitous discovery flourished. Today, targeted research is pretty much all there is. Yet, as Richard Feynman put it in his typical rough-hewn but insightful manner, giving more money 'just increases the number of guys following the comet head.' Money doesn't foster new ideas, ideas that drive science; it only fosters applications of old ideas, most often enabling improvements but not discoveries."

Happy Accidents. Arcade Publishing, Inc 2007:303



"We all make mistakes and, if you believe medical scholar John Ioannidis, scientists make more than their fair share. By his calculations, most published research findings are wrong. Dr. Ioannidis is an epidemiologist who studies research methods at the University of Ioannina School of Medicine in Greece and Tufts University in Medford, MA. In a series of influential analytical reports, he has documented how, in thousands of peer-reviewed research papers published every year, there may be so much less than meets the eye. These flawed findings, for the most part, stem not from fraud or formal misconduct, but from more mundane misbehavior: miscalculation, poor study design or self-serving data analysis. 'There is an increasing concern that in modern research, false findings may be the majority or even the vast majority of published research claims,' Dr. Ioannidis said. 'A new claim about a research finding is more likely to be false than true.?The hotter the field of research the more likely its published findings should be viewed skeptically, he determined. Take the discovery that the risk of disease may vary between men and women, depending on their genes. Studies have prominently reported such sex differences for hypertension, schizophrenia and multiple sclerosis, as well as lung cancer and heart attacks. In research published last month in the Journal of the American Medical Association Dr. Ioannidis and his colleagues analyzed 432 published research claims concerning gender and genes. Upon closer scrutiny, almost none of them held up. Only one was replicated. Statistically speaking, science suffers from an excess of signifi-cance. Overeager researchers often tinker too much with the statistical variables of their analysis to coax any meaningful insight from their data sets. 'People are messing around with the data to find anything that seems significant, to show they have found something that is new and unusual,' Dr. Ioannidis said. In the US, research is a $55-billion-a-year enterprise that stakes its credibility on the reliability of evidence and the work of Dr. Ioannnidis strikes a raw nerve. In fact, his 2005 essay 'W hy Most Published Research Findings Are False' remains the most downloaded technical paper that the journal PloS Medicine has ever published."

Wall Street Journal. September 13, 2007



"Four years after Texas voters approved a constitutional amendment limiting awards in medical malpractice lawsuits, doctors are responding as supporters predicted, arriving from all parts of the country to swell the ranks of specialists at Texas hospitals and bring professional health care to some longunderserved rural areas. The influx, raising the state's abysmally low ranking in physicians per capita, has flooded the medical board's offices in Austin with applications for licenses, close to 2,500 at last count. The Texas Medical Board reports licensing 10,878 new physicians since 2003, up from 8,391 in the prior four years. It issued a record 980 medical licenses at its last meeting in August, raising the number of doctors in Texas to 44,752, with a backlog of nearly 2,500 applications. Of those awaiting processing, the largest number, after Texas, come from New York (145), followed by California (118) and Florida (100). In some medical specialties, the gains have been especially striking, said Jon Opelt, executive director of the Texas Alliance for Patient Access, a medical advocacy group: 186 obstetricians, 156 orthopedic surgeons and 26 neurosurgeons. Adding to the state's allure for doctors, Mr. Opelt said, was an average 21.3 percent drop in malpractice insurance premiums, not counting rebates for renewal.?

New York Times. October 5, 2007



"Van Jones is a rare bird. He's a black social activist in Oakland, CA, and as green an environmentalist as they come. He really gets passionate, and funny, when he talks about what it's like to be black and green: 'Try this experiment. Go knock on someone's door in West Oakland, Watts or Newark and say: "We gotta really big problem!" They say: "We do? We do?" "Yeah, we gotta really big problem!" "We do? We do?" "Yeah, we gotta save the polar bears! You may not make it out of this neighborhood alive, but we gotta save the polar bears!"' Mr. Jones then just shakes his head. You try that approach on people without jobs who live in neighborhoods where they've got a lot better chance of getting killed by a passing shooter than a melting glacier, you're going to get nowhere--and without bringing America's underclass into the green movement, it's going to get nowhere, too. 慦e need a different onramp?for people from disadvantaged communities, says Mr. Jones."

New York Times. October 17, 2007



"The social scientist Charles Murray has a knack for noisily tapping into cultural preoccupations. In his 1984 book, 'Losing Ground,' he argued that welfare perpetuated dependency and should be eliminated. In The Bell Curve (1994), which he wrote with Richard J. Herrnstein, he argued that those who get ahead in America (mostly whites) are genetically endowed with more intelligence than those who do not (disproportionately African-Americans). Now Mr. Murray is at it again, proposing in a recent article to abolish the SAT. This position cannot help but provoke a double-take. After all, while making his arguments about genes, race and intelligence, Mr. Murray promoted the IQ test as a reliable measure of aptitude. Yet he is suggesting that one of the most widely used assessment tests be eliminated. With so many college officials and parents dissatisfied with the SAT, even those who think Mr. Murray's other theories are misguided or offensive could find themselves agreeing with him on this issue. Unlike other critics of the SAT, Mr. Murray does not see the test as flawed, nor does he think that the wealthy have an unfair advantage because they can buy expensive coaching. But he recognizes that most people do not agree with him and believe the test is rigged to favor the rich. 'It is a corrosive symbol of privilege,' he said. And so, he concludes that college admissions offices should reject the SAT and substitute other standardized tests: subject or so-called achievement tests that gauge knowledge in specific disciplines like history or chemistry. 'This is really a hot topic,' said William R. Fitzsimmons, the dean of admissions and financial aid at Harvard University."

New York Times. September 19, 2007



“Case reports are well known to be the lowest and most useless form of evidence. Various commentators on evidence-based medicine have been known to snort derisively when they are mentioned as ‘potential papers,’and they are dying out of most major journals. However, what is ‘well known’is not necessarily true. Consider, for example, the diagnostic value of a raised CRP. There are some, limited instances where case reports and well observed series can obviate the need for randomized trials. Pediatricians can turn to the value of empirical antibiotics in febrile neutropenia, inhaled salbutamol in acute asthma or the classical appearance of a child with Down syndrome. These instances have something in common-they are all examples of ‘all or none’(or ‘almost all and nearly none’ effects. Before a treatment, everyone dies. After a treatment, some don’t. It can be statistically calculated when an interesting observation becomes profound enough to be truth (Glasziou et al and e-responses). This technique compares the rate of something happening before an intervention, and the rate afterwards. If the success rate is about ten times (or more) greater with than without the intervention, then it’s probably a real effect. However, there are far more times when a single case doesn’t prove anything than occasions when it does, but don’t let anyone tell you the case report is useless.”

Arch Dis Child 2007;92:817-824



“Background. It has been hypothesized that early exposure to thimerosal, a mercury-containing preservative used in vaccines and immune globulin preparations, is associated with neuropsychological deficits in children. Methods. We enrolled 1047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders.) Exposure to mercury from thimerosal was determined from computerized immunization records, medical records, personal immunization records, and parent interviews. Information on potential confounding factors was obtained from the interviews and medical charts. We assessed the association between current neuropsychological performance and exposure to mercury during the prenatal period, the neonatal period (birth to 28 days), and the first 7 months of life.
Results. Among the 42 neuropsychological outcomes, we detected only a few significant associations with exposure to mercury from thimerosal. The detected associations were small and almost equally divided between positive and negative effects. Higher prenatal exposure was associated with better performance on one measure of language and poorer performance on one measure of attention and executive functioning. Increasing levels of mercury exposure from birth to 7 months were associated with better performance on one measure of fine motor coordination and on one measure of attention and executive functioning. Increasing mercury exposure from birth to 28 days was associated with poorer performance on one measure of speech articulation and better performance on one measure of fine motor coordination.
Conclusions. Our study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and deficits in neuropsychological functioning at the age of 7 to 10 years.”

N Engl J Med 2007; 357:1281-1292



"For many doctors there are no consequences for poor performance--no financial penalties from the insurers who pay most of the bills. Unbeknownst to many busy physicians, this is all changing. Under a federal law that took effect this summer, Medicare will pay doctors a 1.5 percent bonus incentive for reporting quality measures set out by a program called P.Q.R.I., for Physician Quality Reporting Initiative. This represents a significant step toward public reporting and pay for performance. Hospital quality data is already being posted on Medicare's Web site, www.hospitalcompare.hhs.gov. It is now easy to find out how a given hospital compares with the national average for death rates from common illnesses like heart attack, as well as the hospital's performance on 21 quality measures (like giving aspirin and smoking-cessation advice to heart attack patients). Hospitals now receive incentives for reporting such data; soon their actual payments will be based on their performance on these measures. Just as managed care swept the health system a decade ago and left its mark, so should this new policy, which Medicare calls value-based purchasing. Soon, doctors will be paid according to quality and value. And our performance will be publicly reported on the Internet so our patients can choose the best doctors. With doctors' reputations at stake, they will have an incentive to improve. Though value-based purchasing sounds promising, such an approach has several potential land mines. Doctors will have an incentive to treat the less ill patients, because the outcome is bound to be better. Imagine the consequences if doctors cherrypick patients on that basis. (Medicare does adjust its report cards for severity of illness, yet doctors are skeptical.) Also, doctors already fed up with the bureaucracy and paperwork of Medicare may wash their hands of the program and refuse to see any Medicare patients, just as vast numbers of baby boomers begin turning 65 and entering the program. How value-based purchasing will affect health care only time and human behavior will tell. But change is urgent for our misaligned health care system."

New York Times. September 24, 2007


"First, there was the question of the title: 'The Dangerous Book for Boys.' HarperCollins Publishers' Chief Executive Jane Friedman just didn't understand what it meant. Sure, the book had been a hit in England and Australia, but that didn't mean it would work in the US. But the sales staff urged her to stick with it, and in just two weeks, 'Dangerous' has become the breakout hit of the season. The News Corp unit initially ordered up 91 000 copies. There are now 405 000 copies in print. One senior HarperCollins executive, extrapolating from overseas sales and population data, projects that 'Dangerous,' which lists for $24.95, could sell as many as four million in the US. . . . The book, by English brothers Conn and Hal Iggulden, purports to aim itself at a particularly inscrutable and un-bookfriendly audience: boys around the age of 10. It tries to answer the question: What do boys need to know? So here are instructions on how to skip stones, fold a paper hat, make a battery, and hunt and cook a rabbit. It includes a description of the Battle of Thermopylae, but also how to play Texas Hold 'Em poker, and use the phrases 'Carpe diem' and 'Curriculum vitae.' The unapologetic message is that boys need a certain amount of danger and risk in their lives, and that there are certain lessons that need to be passed down from father to son, man to man. The implication is that in contemporary society basic rules of maleness aren't being handed off as they used to be. The book aims to correct that. It does so with a pretelevision, prevideogame sensibility, and also by embracing a view of gender that has been unfashionable in recent decades: that frogs and snails and puppy dogs' tails are more than lines in a nursery rhyme, and that boys are by nature hard-wired differently than girls."

Wall Street Journal. May 18, 2007



"As if we didn't have enough real problems to worry about, an international media frenzy has erupted over a flotilla of 'yellow rubber duckies' from the Pacific Ocean. The ducks are supposedly about to storm the beaches of the British Isles, 15 years after they spilled off a container ship 10,000 miles away. Reporters from Scotland, England, Germany, several other EU countries, Canada, Brazil, Australia, New Zealand, Japan and the US have been emailing me urgent questions about the ducks: Have they been sighted in Britain yet? When will they land, and where? I have been tracking these wayward bathtub toys for 15 years, with the help of an international network of dedicated beachcombers. We have collected data on these floaters--where they beach, and when--in order to better understand the oceans' currents: where they flow, how fast they flow, and how and when they interconnect. . . . The 29 000 celebrated bathtub toys that fell into the Pacific in January 1992 aren't made of rubber, they're plastic. . . . Their 11-year journey began in the central Pacific, about where the International Date Line crosses the 45th parallel. They proceeded eastward to southeast Alaska, where beachcombers recovered thousands of their fellows. From there, the two toys drifted north to the Bering Sea, across the North Pole, south along eastern Greenland, and further south to Newfoundland, where their paths diverged--one to Maine and the other to Britain. To complete these journeys, they had to ride four circular oceanic currents called 'gyres' or 'carousels of the seas.' To understand these gyres, we have also tracked 80 000 Nike shoes lost in another North Pacific cargo spill (each one bearing a code for the container from which it spilled), 34 000 spilled hockey gloves, five million Lego pieces lost off England's Land's End and Japanese survey stakes that typhoons have washed out into the Pacific. . . . By roaming the world's beaches and seeing what washes up, we have also learned that there is far too much man-made stuff floating on the seas, especially stuff made out of plastic--now found in eight vast oceanic garbage patches. Most of it does not biodegrade. It just breaks down into ever smaller pieces, to the size of confetti and, finally, dust. Fish, birds and other marine animals eat this pseudo-plankton and pass it up the food chain. Our world-wide litter is poisoning the seas, the creatures within them, and ultimately, ourselves. . . . These humble toys have piqued curiosity and stimulated imaginations around the world, but they can also yield important scientific data. If you spot one of the bathtub toys, please take a picture, look for the words 'The First Years' imprinted on each toy (see photos at www.beachcombers.org), and send a note to curtisebbesmeyer@comcast.net. You might also consider joining the beachcombers who patrol and clean our shorelines. You can help us better understand and protect our magical but fragile oceans and their powerful, circulating currents."

Wall Street Journal. August 3, 2007



Background: Drotrecogin alfa (activated) (DrotAA) is used for the treatment of adults with severe sepsis who have a high risk of dying. A phase 1b open-label study has indicated that the pharmacokinetics and pharmacodynamics of DrotAA are similar in children and adults. We initiated the RESOLVE (REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspectiVE) trial to investigate the efficacy and safety of the drug in children.
Methods: Children aged between 38 weeks?corrected gestational age and 17 years with sepsis-induced cardiovascular and respiratory failure were randomly assigned to receive placebo or DrotAA (24_g/kg/h) for 96 h. . . .
Findings: 477 patients were enrolled: 237 received placebo, and 240 DrotAA. Our results showed no significant difference between groups. . . .
Interpretation: Although we did not record any efficacy of DrotAA in children with severe sepsis, serious bleeding events were similar between groups and the overall safety profile acceptable, except in children younger than 60 days. However, we gained important insights into clinical and laboratory characteristics of childhood severe sepsis, and have identified issues that need to be addressed in future trials in critically ill children.

Lancet. March 10, 2007



"Day by day, the doctors unwittingly helped the bacteria infecting their young heart patient to evolve. The more intensively they treated his affliction with antibiotics, the more the microbes resisted the therapy. . . . Last month, an international team of 11 scientists, led by biologists at Rockefeller University in New York, for the first time identified the genetic changes that occurred as Staph bacteria developed resistance to successive antibiotics, step by step, in the living test tube of a sick man. To document events inside these virulent cells, Rockefeller University biologist Michael Mwangi and his colleagues analyzed the infection's genetic code as it changed in a series of blood samples taken during the patient's stay. Their work, reported in the Proceedings of the National Academy of Sciences, details how the molecular mechanics of survival are strengthening many deadly diseases. Patient X died in October 2000 after a 12-week hospital stay. His case comes to light now because researchers only recently developed the computational techniques needed to sequence generations of bacteria. The hospital, which also wasn't identified, gave the patient's Staph samples to the Rockefeller team for research purposes. The techniques still are too slow and expensive for clinical use. . . . When Patient X was admitted to the hospital, he was already suffering from a Staphylococcus aureus infection, but it was still vulnerable to antibiotics. During treatment, however, the bacteria quickly developed stronger resistance to four antibiotics, including vancomycin, the drug of last resort for intractable infections, the scientists reported. As living bacteria, the Staph were driven to survive. Every time the patient took his medicine, the antibiotics killed the weakest bacteria in his bloodstream. Any cell that had developed a protective mutation to defend itself against the drug survived, passing on its special trait to descendants. . . . These resistant microbes, all disease-producing organisms spawned by the original infection, quickly accumulated 35 useful mutations. Each one altered a molecular sensor or production of a protein. Researchers then matched these gradual genetic changes to increasing levels of drug resistance, shocked that it took so little to undermine the foundation of modern infectious-disease control. 'we have now really looked into the belly of the beast and seen the mechanism,' said Rockefeller microbiologist Alexander Tomasz. . . . The death of Patient X highlights the speed of natural selection in fostering antibiotic resistance. 'when you talk about the evolution of an arm or an eye or a species, you might be talking about millions of years. You can get bacteria resistant in a week,' Dr Mwangi said."

Wall Street Journal. June 8, 2007


“It took 14 years, but science finally trumped politics Friday, with the Food and Drug Administration's lifting of its longstanding ban on silicone-gel breast implants. Women will at last be allowed to make their own decisions about cosmetic surgery. This is especially welcome news for mastectomy patients. The FDA removed them from the market in 1992 during the reign of Commissioner David Kessler, a politically ambitious bureaucrat who was courting support from the left. The agency cited health concerns that have long since been debunked, and silicone-gel breast implants have since been at the heart of one of the trial bar's biggest scams. Class-action lawsuits raked in billions of dollars and drove implant makers out of the business. Dow Corning went into bankruptcy. Throughout it all, the trial bar was abetted by a gullible press, only too happy to ignore the science and play up sensationalist stories of supposed 'victims.'Meanwhile, as we reported in editorials at the time, study after study showed no linkage between silicone breast implants and cancer, lupus, the skin-hardening disease scleroderma or other serious illness. As far back as 1994, doctors at the Mayo Clinic found 'no association between breast implants and the connective-tissue disease and other disorders' that they studied. In 1999, the Institute of Medicine found no systemic health problems caused by implants. In 2003, an FDA advisory panel advised that the ban be removed."

New York Times. November 21, 2006



" long-awaited plan to shrink New York State's hospital industry landed yesterday with force, with proposals that could effectively eliminate 20 or more hospitals and thousands of jobs, and force dozens of other hospitals to shrink, merge or take on new roles. The recommendations by the Commission on Health Care Facilities in the 21st Century go far beyond the nine hospital closings and downsizings that state officials reported late Monday, after being briefed by the commission. Several other hospitals would cease to exist through merges or conversion to new uses, and more could be eliminated if they refuse to merge. In addition, the commission reached deep into the particular operations of many individual institutions, ordering them to eliminate specific numbers of beds, telling some to eliminate sychiatric, substance abuse or maternity wards, and in some cases directing others to take on those functions. The changes would mark an epochal shift in an industry that, person for person, is much bigger in New York than in other states, and traditionally has fiercely resisted shrinkage. But hospitals are also in worse financial shape in New York than in any other state, having lost money for eight consecutive years."

New York Times. November 29, 2006



"The average American home now has more television sets than people . . .according to Nielsen Media Research. There are 2.73 TV sets in the typical home and 2.55 people, the researchers said."

Associated Press. New York Times. November 22, 2006



"federal appeals court, for a second time, threw out a prison sentence for Michael Martin, the former finance chief for HealthSouth, calling the sentence too lenient for his role in a $2.7 billion fraud at the company. . . . "If any sentence is unreasonable, it is this one,"the appellate court said. "It is not remotely commensurate with the seriousness and extensive scale of the crimes and dose not promote respect for the law."Mr Martin was one of 15 executives to plead guilty to inflating profits at HealthSouth, a rehabilitation hospital chain based in Birmingham, AL, in an attempt to bolster share price and meet Wall Street analyst expectations."

Bloomberg News. New York Times. July 12, 2006



"Context: Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations.

Objective: To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old.

Conclusions: In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine." or medications and 20% had no programs for patient education."

Hambidge SJ, Glanz JM, France EK, et al. JAMA. 2006;296:1990-1997



"Separating anatomy from what it means to be a man or a woman, New York City is moving forward with a plan to let people alter the sex on their birth certificate even if they have not had sex-change surgery. Under the rule being considered by the city's Board of Health, which is likely to be adopted soon, people born in the city would be able to change the documented sex on their birth certificates by providing affidavits from a doctor and a mental health professional laying out why their patients should be considered members of the opposite sex, and asserting that their proposed change would be permanent. Applicants would have to have changed their name and shown that they had lived in their adopted gender for at least two years, but there would be no explicit medical requirements."

New York Times. November 7, 2006



" . . safety experts are targeting medical practices in a bid to prevent harm to patients and reduce the threat of malpractice suits from thousands of adverse drug events that send 700 000 outpatients to emergency rooms each year. Three leading health-care research-and-safety organizations are offering a new, Web-based "Physician Practice Patient Safety Assessment" to help doctors evaluate how well they run their offices, including tools to help improve their systems for tracking medication used and safety, transferring information to other doctors and communicating with patients . . . . Data from . . . 164 practices that filled out . . . assessment[s] showed that 31% were unaware of or hadn't implemented safety procedures for medications and 20% had no programs for patient education."

Wall Street Journal. November 15, 2006



"Patients presenting with the combined finding of severe symptomatic hyponatremia and hypoxia have such high mortality rates that they should be admitted to an intensive care unit and intubated sooner rather than later. Without delay, these patients need rapid correction of their serum sodium by 8-10 mequiv. per liter and an increase in their partial pressure of arterial oxygen to values above 70 mm Hg."

Kidney International. 2006;69:1291-1293



"The. . . administration says it plans sweeping changes in Medicare payments to hospitals that could cut payments by 20 percent to 30 percent for many complex treatments and new technologies. The changes, the biggest since the current payments system was adopted in 1983, are meant to improve the accuracy of payment rate. But doctors, hospitals and patient groups say the effects could be devastating. Federal officials said that biases and distortions in the current system had crested financial incentives for hospitals to treat certain patients, on whom they could make money, and to avoid others, who were less profitable."

New York Times. July 17, 2006



"Edward Lowe invented cat litter in 1947. Here's how he did it: He took a type pf water-absorbent granulated clay known as "fuller's earth" which was commonly used to soak up grease spills in factories, and poured it into brown paper bags, on the sides of which he wrote the words Kitty Litter. By the time Lowe died in 1995, cat litter had evolved from a mere commodity to a variety of specialized products supporting a highly competitive billion-dollar industry-and cats had replaced dogs as America's most welcome presence in the home. . . . Kitty Litter brand is no more, as the name has become a generic term for cat litter. Edward Lowe sold his business for $200 million in 1990."

Invention & Technology. Summer 2006



"A recent decision by a New York court is a stark reminder that despite far-reaching reforms junk science still plagues American court rooms. The case, Nonnon v. City of New York, involves a group of plaintiffs claiming that exposure to toxics substances in New York City's Pelham Bay landfill caused their cancers. They presented no study to the trial court showing that any substance found in the landfill causes their types of cancer; and the testimony of their expert witnesses was speculative and based on a single methodologically deficient study. . . . The outcome would likely have been different had the suit been brought in federal court. That's because cases based on the sorts of "quackspertise"that once led to multimillion dollar payouts for trial lawyers-claims that breast implants cause immune-system disease, power lines cause leukemia, vaccines cause autism, and the like-oow routinely get dismissed before trial. The reason is a strict reliability test for expert testimony first announced by the US Supreme Court in the 1 993 cases of Daubert v. Merrell Dow Pharmaceuticals. But Daubert's reliability test, codified in Federal Rule of Evidence 702, only governs federal trials. Plaintiffs with personal injury claims backed by dubious (or worse) expert testimony have thus become ever more determined to keep their lawsuits in state courts where, naturally, plaintiff attorneys have fought every effort to adopt Daubert and Rule 702. The trial lawyers have inertia on their side, and Daubert's reception has been particularly unfriendly in some of the most populous and influential states."

Wall Street Journal. October 1, 2006



"With catchy slogans like "You're Sick! We're Quick!"retail health clinics are spreading fast in supermarkets, drugstores and big-box chains across the country, luring patients with walk-in treatment for minor ailments like strep throat-at about half of the cost of a typical doctor visit. The phenomenon has been largely driven by small start-up chains, such as Minute Clinic, RediClinic and Take Care Health Systems, which run the outlets under agreement with retailers and have had few formal ties to the medical establishment. Now, traditional medical providers are stepping up to the counter, driven by the threat of new competition, the opportunity to recruit new patients, and real concerns about the quality of care. Some large regional health-care systems are starting their own clinics directly with retail partners, while other medical groups and doctors offices are signing contracts to supervise clinic staff, and striking up referral arrangements with retail clinics."

Wall Street Journal. July 26, 2006



“In his 2004 book, "The Empty Cradle: How Falling Birthrates Threaten World Prosperity and What to Do About It,"Phillip Longman exploded one of the planet's most enduring modern myths. He demonstrated that population growth is not the threat that it has been made out to be and that population decline is the real challenge ahead of us. By the time of the book's publication, many developed nations were already struggling to address the obvious result of falling fertility: What to do when so few babies are being born that eventually there won't be enough workers to sustain your country's economy, let alone support the elderly? One of the most recent answers comes from Portugal, where the birthrate has fallen to 1.7-below the replacement rate of 2.1 children per couple. The government there has come up with a plan to give tax breaks to people who have more than two children and to levy higher taxes on those who have fewer than two. Singapore, France, Sweden and many other states already employ various incentives to encourage parenthood. . . . What a change from only a few decades ago, when conventional wisdom had it that the only route to prosperity was smaller families."

Wall Street Journal. June 2, 2006



'For uncounted millenniums, humans raised their children with mothers breast-feeding their children for 2 to 3 years. In some culture the use of wet nurses was also common. In the mid 18th Century, Hunter, a Scottish doctor, emphasized the need for mothers to breast feed their children in order to minimize the risk of getting "milk fever" In more modern and industrialized societies, women started to schedule the breast feeding to set periods of 4 to 6 times per day. This, in turn, increased the child's need for additional sucking time to satisfy the sucking urge. In some cultures, it was common to provide the child with a knotted strip of clothes that enclosed honey or other foods for the child to suck on. The concept is similar to the use of the modern pacifiers introduced in the second part of the 19th Century. In many parts of the world, 80 to 90% of the children start a digit or pacifier sucking habit. For the child, it is especially difficult to break his thumb sucking habit since finger is always available. As a result, the habit often leads to various malocclusions e.g. the maxillary arch is forced forward and the upper incisors become protruded. Pacifier sucking opens the bite and affects the transverse dimensions of the deciduous canines. These changes that accompany such habits could adversely affect the development of the dental arches. Therefore, dental occlusion should be evaluated periodically even in young children. Any malocclusion present should be diagnosed and if needed treated by the medical and dental professionals who are dealing with the well being of these children."

Larsson E. Bishara S, ed. www.thumbandpacifiersucking.com



"Clinical trails of medicines are traditionally performed in a "blinded" fashion so that the findings will remain secret until the studies are completed. But regulators and pharmaceutical industry are increasingly interested in the starting to use a very different model that lets studies change as they go along, based on early results. Drug companies have begun to perform such adaptive trials for their new medicines, hoping for more efficient tests that could save millions of dollars. The Food and Drug Administration, meanwhile, is sending increasingly encouraging signs that it is open to considering the results of such trails, Scott Gottlieb, an FDA deputy commissioner, is set to announce today plans to develop regulatory guidelines for adaptive trials. . . . Advocates of adaptive designs say they can involve a reduction of 30% or more in the number of patients needed in a trail, and can save time as well. They also say that adaptive trials carry major benefits for patients, who have reduced odds of getting a less-effective treatment. . . . Bristol-Myers Squibb Co. is planning a migraine-drug trial that will use adaptive principles to help determine how much medicine to give. The study will start with 10-15 different doses, far more than the three or four the company would typically give in a traditional trial. As data comes in, new patients will be routed to the doses showing the best results, so by the end only a few doses will remain active. But researchers and regulators say that such trails also raise serious questions. Perhaps the biggest concern is that allowing access to ongoing trail results could introduce bias if the sponsor or the doctors running the trial-or the patients taking part in it-learn about them and consciously change their conduct on an ad hoc basis. Another worry is that preliminary findings could leak out to investors. Adaptive designs can work, but they are also "much more open to abuse,"says Truce Turnbull, a professor of statistics as Cornell Unversity in Ithaca, NY."

Mathews AW. Wall Street Journal. July 10, 2006



“One sunny afternoon in January, Vicki Chandler, a 55-year-old underwriting associate at Cigna Health Care in Chattanooga, Tenn., was walking to her car when a teenager in loose khaki pants approached her, pointed to her pocketbook and said, ‘I need that.'As she recounts the incidence, he snatched the purse and took off. Then he ran into trouble. As he ran, his loose trousers slipped down below his hips. As he reached down to hold them up, the teen was forced to throw the purse aside. 'That boy, he could run fast but he got caught up by his pants, which were real big baggy,'says Ms. Chandler, whose purse was retrieved by a parking attendant who had heard her cries for help. It's a problem for perpetrators. Young men and teens wearing low-slung, baggy pants fairly regularly get tripped up in their getaways, a development that has given amused police officials and law-abiding citizens a welcome edge in the fight crime."

Ng S. Wall Street Journal. June 20, 2006



"A report planned for release today indicates that the average physician's net income declined 7 percent from 1995 to 2003, after adjusting for inflation, while incomes of lawyers and other professionals rose by 7 percent during the period. The researchers who prepared the report say the decline in doctor's inflation-adjusted incomes appears to be affecting the types of medicine they choose to practice and the way they practice it, resulting in fewer primary care doctors and a tendency to order more revenue-generating diagnostic tests and procedures. Primary care doctors, who are already among the lowest-paid physicians, had the steepest decline in their inflation-adjusted earnings-a 10 percent drop-according to the report by the Center for Studying Health System Change, a nonprofit research group in Washington. The average reported net income for a primary care physician in 2003 was $146,405, according to the study, after expenses like malpractice insurance but before taxes. The highest-paid doctors were surgeons who specialize in areas like orthopedics, who hand an average net f of $271,652, nearly double what the primary care doctors said they earned. The report was based on a national telephone survey of roughly 6,600 physicians in 2004 and 2005 and earlier surveys by the research center."

Abelson R. New York Times. June 22, 2006


3. “ . .encourages investigators to register their clinical trials in a public trials registry. The members of the International Committee of Medical Journal Editors plan to consider clinical trials for publication only if they have been registered (see N Eng J Med 2004; 351.1250.1). The National Library of Medicine's www.clinicaltrials.gov is a free registry, open to all investigators, that meets the committee's requirements.”

N Eng J Med. 354;16, June 15, 2006



"Australian hospitals are bracing for a baby boom next month as pregnant women try to delay births to take advantage of a new welfare payment, researchers said. Beginning July 1, a baby bonus paid to the parents for every newborn will increase by $740, to $3,000. Economists said after the baby bonus was introduced in 2004, about 700 births were delayed by a week to take advantage of the payment."

New York Times. June 21, 2006



“A Food and Drug Administration official called in May for a drug company to halt clinical trials of an antibiotic in children because the drug could be deadly, according to internal memorandums sent to other FDA officials. The drug, Ketek, made by Sanofi-Aventis, is being tested as treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, including the United States, according to posting on a government Web site. But Ketek, which is currently approved for use only in adults, has been reported to cause liver failure, blurred vision and loss of consciousness in adults. . . . Sanofi-Aventis is sponsoring four clinical trials in children ages 6 months to 13 years, according to the Web site posting. The drug agency approved plans for the trials. There is growing evidence that Ketek is unusually toxic, according to a recent review by FDA safety officials. . . . The safety officials wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects. . . . Dr. Johann-Liang wrote in her memorandum that the parents of patients in Sanofi-Aventis's pediatric trials must be better informed about Ketek's risks 'In order for any of these trials to continue to proceed.'She added that the parents 'need to know that the "close monitoring" for visual events is not possible in very young children, and the long-term consequences of such adverse reactions are unknown for the developing system.'"

Harris G. New York Times. June 8, 2006


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