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… Just a quick review: In the 1950s and 1960s, the U.S. dominated the world in K-12 education. We also dominated economically. In the 1970s and 1980s, we still had a lead, albeit smaller, in educating our population through secondary school, and America continued to lead the world economically, albeit with other big economies, like China, closing in. Today, we have fallen behind in both per capita high school graduates and their quality. Consequences to follow.
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For instance, in the 2006 Program for International Student Assessment that measured the applied learning and problem-solving skills of 15-year-olds in 30 industrialized countries, the U.S. ranked 25th out of the 30 in math and 24th in science. That put our average youth on par with those from Portugal and the Slovak Republic, 'rather than with students in countries that are more relevant competitors for service-sector and high-value jobs, like Canada, the Netherlands, Korea, and Australia,' McKinsey noted.
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Actually, our fourth-graders compare well on such global tests with, say, Singapore. But our high school kids really lag, which means that 'the longer American children are in school, the worse they perform compared to their international peers,' said [a new study by the consulting firm McKinsey, entitled 'The Economic Impact of the Achievement Gap in America's Schools.'
It is not that we are failing across the board. There are huge numbers of exciting education innovations in America today from new modes of teacher compensation to charter schools to school districts scattered around the country that are showing real improvements based on better methods, better principals and higher standards. The problem is that they are too scattered leaving all kinds of achievement gaps between whites, African-Americans, Latinos and different income levels.
From 4-21-09 New York Times, "Op-Ed Columnist: Swimming Without a Suit," By THOMAS L. FRIEDMAN.
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When a huge explosion occurred last August at a West Virginia chemical plant, managers refused for several hours to tell emergency responders the nature of the blast or the toxic chemical it released, and they later misused a law intended to keep information from terrorists to try to stop federal investigators from learning what had happened, members of a House subcommittee said Tuesday.
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The explosion, at Bayer CropScience, in Institute, W. Va., killed two employees and sickened six volunteer firefighters. It was felt 10 miles away, and a tank weighing several thousand pounds 'rocketed 50 feet through the plant,' committee investigators found.
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Fortunately, it did not go in the direction of a tank holding the same chemical that killed thousands in a 1984 chemical plant explosion in Bhopal, India. Devices meant to detect releases of the chemical, methyl isocyanate, or MIC, had been disabled, and video cameras had been disconnected, steps that 'raise concerns about an orchestrated effort by Bayer, a subsidiary of Bayer AG, to shroud the explosion in secrecy,' said the subcommittee chairman, Representative Bart Stupak, Democrat of Michigan.
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After the Bhopal catastrophe, Congress created an independent agency, the Chemical Safety and Hazard Investigation Board, to investigate chemical accidents in this country. But Bayer's chief executive, William Buckner, said in his prepared testimony that company officials believed they could 'refuse to provide information' to the board.
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The plant was previously owned by Union Carbide, which also owned the plant in Bhopal that had released tons of MIC in December 1984. Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee, noted that the same month in 1984, he had held a hearing at the West Virginia plant, near Charleston, to inquire about safe use of the chemical.
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'I think it's finally time to ask whether it makes sense to allow Bayer to continue producing and storing such massive amounts of this highly toxic chemical,' Mr. Waxman said Tuesday.
From 4-21-09 New York Times, "Lawmakers Say Chemical Company Withheld Information About Explosion," By MATTHEW L. WALD.
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But while hospitals and drug companies often have more negotiating leverage than insurers, it is also true that insurers don't go out of their way to compete on the basis of price. The market in most regions is dominated by two or three big players that have learned they are better off raising prices in tandem than getting into price wars from which only the customers emerge as winners. Rather than compete on price, insurers compete to attract the healthiest patients.
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That's why advocates of a public option believe a government insurance plan is needed to bring more robust price competition to the market, using its size to extract lower prices from providers and passing those savings on to consumers. Medicare already effectively dictates the prices it is willing to pay to doctors and hospitals, and there are very few providers who choose to opt out of the system. A public insurance plan for the non-elderly could simply piggyback on those lower Medicare prices.
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The problem with this arrangement is that Medicare is so powerful that it can get away with paying only 80 to 85 percent of actual costs, forcing doctors and hospitals to overcharge private insurers to make up the difference. Private insurers fear that if they were forced to compete against a public plan with that kind of cost disadvantage, they would be driven out of the market. And doctors and hospitals warn that, without private insurers to overcharge, they'll wind up out of business, as well.
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Uwe Reinhardt, a Princeton University economist, has a simple fix for this screwy pricing system. Reinhardt suggests that, once a year, each hospital or physicians group come up with a list of prices for individual procedures, or bundles of services, that it is willing to offer to any and all insurers, regardless of size. After reviewing the offers, Medicare and private insurers can then announce what price they are willing to pay and give providers one last chance to adjust their offers accordingly. After that, everyone would be free to do business with whomever they choose on the basis of the posted bids.
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There is, of course, a name for such an arrangement. It's called a free market -- in this case a market open to multiple buyers and sellers with regular bidding and transparent pricing. More to the point, it is a market that would work whether there was a public insurance option or not.
From 3-10-09 Washington Post, "A 'Public' Fix for Health Care Need Not Abandon the Market," By Steven Pearlstein.
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Here we have [in today's colleges] a generation of young adults away from home for the first time, free to enjoy the most experimental period of their lives, yet they're choosing books like 13-year-old girls -- or their parents. The only specter haunting the groves of American academe seems to be suburban contentment.
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Professor Eric Williamson -- a card-carrying liberal in full tweed glory -- argues that 'the entire culture has become narcotized.' An English teacher at the University of Texas-Pan American, he places the blame for students' dim reading squarely on the unfettered expansion of capitalism. 'I have stood before classes,' he tells me, 'and seen the students snicker when I said that Melville died poor because he couldn't sell books. 'Then why are we reading him if he wasn't popular?' ' Today's graduate students were born when Ronald Reagan was elected, and their literary values, he claims, reflect our market economy. 'There is nary a student in the classroom -- and this goes for English majors, too -- who wouldn't pronounce Stephen King a better author than Donald Barthelme or William Vollmann. The students do not have any shame about reading inferior texts.'
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Roger Kimball, editor and publisher of the New Criterion, marches in the other direction -- he has no complaints about the market economy -- but he arrives at the same dismal appraisal of the academic culture. Universities and colleges 'enforce an intellectually stultifying, politically correct atmosphere that pretends to diversity,' he complains. 'One of the results of this is a notable uptick in superficiality and a notable uptick in the anesthetizing of that native curiosity that was once a prominent feature of the adolescent mind.'
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But maybe young people's reading choices reflect our desire to keep them young. David Farber, editor of 'The Sixties: From Memory to History,' says that the way Americans think about the age of maturity has shifted considerably. 'There's much more an emphasis now on kids thinking of themselves as kids, even into their early to mid-20s,' he says. 'But in the '60s, they thought of themselves as agents of historical change. The sit-ins, the civil rights movement, the possibility of being drafted focused the mind. The contagion of protest made everyone think of themselves as possible demonstrators.'
From 3-8-09 Washington Post, "On Campus, Vampires Are Besting the Beats," By Ron Charles.
Read in the Friday, January 30, 2009 Washington Post, "Why Easy Grading Is Good for Your Career," By Jay Mathews.
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Medical and surgical residents in hospitals should work no more than 16 hours without taking a mandatory five-hour sleep break, and they should get one full day off a week and at least two back-to-back days off a month, a panel of experts at the Institute of Medicine recommended yesterday.
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'Our overarching conclusion is that the science clearly shows that fatigue increases the chances of errors, and residents often work long hours without rest and regular time off,' said Michael M.E. Johns, a physician and the chancellor of Emory University who led the 17-member panel.
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The 324-page document is the latest in a series of reports on ways to improve the quality and safety of American medicine. The Institute of Medicine, part of the National Academy of Sciences, provides expert advice to Congress.
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The Accreditation Council for Graduate Medical Education, which oversees residency programs, currently sets the maximum workweek at 80 hours, with shifts to last no more than 30 hours. It also requires that residents get at least four days off per month, although there does not have to be one in each week.
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A survey of about 4,000 interns found that in the first year those rules were in effect, 84 percent reported working shifts that violated them at least one month of the year. Forty-three percent reported working more than 80 hours weekly.
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A study in 1996 found that pediatric residents, who slept on average less than three hours a night when they were on call, were twice as likely to be in car accidents as faculty members, who did not report sleep-deprived nights.
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The panel, which included sleep researchers and quality-assurance experts, as well as physicians, acknowledged that there is a chance the new recommendations could make things worse. That is principally because an enforced sleep break after 16 hours will require more patient 'handoffs' than occur now.
From 12-3-08 Washington Post, "Medical Residents Must Sleep After 16 Hours, Experts Urge," By David Brown, Washington Post Staff Writer.
Link to 12-3-08 New York Times, "The Evidence Gap: British Balance Benefit vs. Cost of Latest Drugs," By GARDINER HARRIS. An interesting article about a British government agency, the National Institute for Health and Clinical Excellence, which decides cost/benefit questions regarding drugs and medical procedures for the National Health Service. Successfully driving down the cost of drugs and medical procedures, the institute is being copied by other countries.
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When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were 'solely in the advancement of medical treatment through rigorous and objective study.'
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But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to 'move forward the commercial goals of J.& J.' The documents also show that the company prepared a draft summary of a study that Dr. Biederman, of Harvard, was said to have written.
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Dr. Biederman's work helped to fuel a fortyfold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children.
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Johnson & Johnson makes a popular antipsychotic medicine called Risperdal, or risperidone. More than a quarter of its use is in children and adolescents.
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Last week, a panel of federal drug experts said that medicines like Risperdal were being used too cavalierly in children and that regulators must do more to warn doctors of their substantial risks. Other popular antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify, made by Bristol-Myers Squibb.
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A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, said Dr. Biederman approached the company 'multiple times to propose the creation' of the center. 'The rationale of this center,' the message stated, 'is to generate and disseminate data supporting the use of risperidone in' children and adolescents.
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Documents show that Johnson & Johnson gave the center $700,000 in 2002 alone. Massachusetts General said in its statement on Monday that grant agreements indicated the center 'was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.'
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A statement Monday from Janssen Pharmaceutica, a unit of Johnson & Johnson, said it helped finance the research center in 2002 'with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.'
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Drug makers have long hired professional writers to compose scientific papers and then recruited well-known doctors to list themselves as the author. The practice, known as ghostwriting, has come under intense criticism recently, and medical societies, schools and journals have condemned it.
From 11-25-08 New York Times, "Research Center Tied to Drug Company," By GARDINER HARRIS.
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A state-by-state analysis by The New York Times found that in the 40 states reporting on their compliance so far this year, on average, 4 in 10 schools fell short of the law's testing targets, up from about 3 in 10 last year. Few schools missed targets in states with easy exams, like Wisconsin and Mississippi [!], but states with tough tests had a harder time. In Hawaii, Massachusetts and New Mexico, which have stringent exams, 60 to 70 percent of schools missed testing goals. And in South Carolina, which has what may be the nation's most rigorous tests, 83 percent of schools missed targets.
From 10-13-08 New York Times, "Under No Child' Law, Even Solid Schools Falter," By SAM DILLON.
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Surveys show that cheating in school plagiarism, forbidden collaboration on assignments, copying homework and cheating on exams has soared since researchers first measured the phenomenon on a broad scale at 99 colleges in the mid-1960s.
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The percentage of students who copied from another student during tests grew from 26 percent in 1963 to 52 percent in 1993, and the use of crib notes during exams went from 6 percent to 27 percent, according to a study conducted by Dr. Donald McCabe of Rutgers. By the mid-1990s, only a small minority said they had never cheated, meaning that cheating had become part of the acceptable status quo.
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Dr. McCabe's later national survey of 25,000 high school students from 2001 to 2008 yielded equally depressing results: more than 90 percent said they had cheated in one way or another.
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Dr. Jason Stephens of the University of Connecticut has now embarked on a three-year pilot program to reduce cheating. His premise is that honesty and integrity are not only values but habits habits that can be encouraged in school settings, with positive benefits later in life.
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The program seeks to enlist students and teachers in six high schools in promoting a culture of honesty. Schools will be asked to consider honor codes, and, since peer pressure is vitally important, students will be invited to help shape policies and strategies to discourage cheating. Two schools are suburban and wealthy, two are middle class, two are urban and poor. One school from each pair will work to end the cheating epidemic, and the other will serve as the control group.
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The challenge is daunting. Students of both genders and every demographic group cheat even though they know it is wrong, a mind-set Dr. Stephens describes as 'a corrosive force' especially when it is acquired in the early years of moral development.
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The fact that so many students cheat doesn't make them intrinsically bad, he says: 'It's not a case of the bad seed. It's more like bad soil.'
From 10-13-08 New York Times, "Editorial Observer: Digging Out Roots of Cheating in High School," By MAURA J. CASEY.
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At the heart of the [economic] troubles, both short term and long term, is debt. Debt helped create the housing bubble and has now left almost one of every six homeowners with a mortgage larger than the value of their home. Debt built up, and then laid low, modern Wall Street, where firms borrowed $30 for every $1 they owned. And in the coming years, debt will constrain the United States government, as it copes with the combined deficits created by the Bush administration's policies, the ever-more expensive financial rescue and the biggest item of all, Medicare for the baby boomers.
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In essence, households, banks and the government have already spent some of their future earnings. The current crisis marks the point at which the bills begin to get paid. Whereas Britain [at the turn of the 20th century] lumbered under the weight of imperial overreach, as the historian Niall Ferguson has written, the United States will be shackled primarily by its financial overreach.
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It is possible, then, that the main legacy of the crisis will be some form of corrective to the country's recent excesses. The economy looks to be heading into a period of more regulated, but still American-style, capitalism, more along the lines of how it operated in the 1950s, 1960s and 1990s. Those three decades happen to have produced the biggest and most widely shared economic gains since World War II.
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But if that outcome is possible, it's not inevitable, and many economists say it isn't even likely. The debts run up in recent years are particularly unfortunate, because they stole resources from the future without laying the groundwork for future growth. 'If you told me we were spending like crazy to build schools and send everyone to college, that would have infinitely different implications than borrowing like crazy to finance current consumption,' said Christina Romer, an economist at the University of California at Berkeley.
From 10-12-08 New York Times, "A Power That May Not Stay So Super," By DAVID LEONHARDT.
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This is
a hard time for D.C. teachers. They are fine people who have chosen a tough profession and put their hearts into their work. Many fear being judged by principals who, unlike [Sarah] Hayes, [principal of the KIPP DC:KEY Academy,] were not skillful teachers themselves and have little clue as to what helps kids learn and what doesn't. But I don't see any way the city's children are going to get the instruction they deserve -- the imaginative, fun-loving, firm teaching found at schools like KEY -- unless principals are given the power to hire and fire teachers based on demonstrated skill and improved learning in class.
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[D.C. Schools Chancellor Michelle A.] Rhee is likely to pick a few principals who fail, much as Hayes erred in hiring the two teachers. But the great virtue of the approach used at KEY and similar charter schools, the approach Rhee wants to adopt, is that achievement results -- not friendships, not union rules, not inertia -- would determine which principals and which teachers keep their jobs. If Hayes and other KIPP principals don't show learning gains, they are out. Rhee says her principals will also be gone if they don't show good results.
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For instance, nationally, KIPP middle schools have been shown to raise average reading achievement from the 32nd to the 60th percentile and math achievement from the 40th to the 82nd percentile for children who stay from grades five through eight. These children, neglected in regular public schools, thrive when they transfer to KIPP. That seems to be because the principals and teachers in their new schools want to be judged by their results and don't need a promise of higher salaries to take the risk that they might fail.
From 9-29-08 Washington Post, "For Kids' Sake, Power to Fire Teachers Crucial," By Jay Mathews; he writes a regular column, "Class Struggle."
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Even as Washington and Wall Street debate the best way to avert an economic disaster, increasing numbers of Americans are struggling with another financial crisis: the growing burden of unpaid medical bills.
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Two studies released Wednesday provide further evidence of the toll that health care is increasingly placing on working families, even for those with health insurance. And as employees are paying more medical expenses out of their own pockets, they are having a harder time coming up with the money.
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The studies, by the Kaiser Family Foundation and the Center for Studying Health System Change, were completed earlier this year before the financial markets reached their current state of crisis. But policy analysts say the findings underscore the mounting additional strain that medical care is placing on working Americans.
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Although inflation in insurance premiums has moderated in recent years, the Kaiser survey found that employees were continuing to spend more in medical costs, including their share of yearly insurance premiums. Employees are paying an average of $3,354 in premiums for family coverage, more than double the amount they paid in 1999. The total cost for family coverage now averages $12,680 a year, up 5 percent from 2007.
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And as people are paying more, they are finding the higher expense less affordable. In the study by the nonpartisan Center for Studying Health System Change, based on its national survey of households, nearly one of every five families had problems paying medical bills last year. More than half of these families said they borrowed money to pay these expenses, and nearly 20 percent of those having difficulty said they contemplated declaring personal bankruptcy as a result of their medical bills.
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The study estimates that 57 million Americans live in families struggling with medical bills, and 43 million of those have insurance coverage. 'It's hitting both the insured and the uninsured, and it's hitting middle-class families,' said Karen Davis, the president of the Commonwealth Fund, a nonprofit research organization that financed the study.
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Because they are already in debt over their medical care, some families start forgoing treatments, even for serious or chronic conditions, Ms. Davis said. By deciding not to fill a prescription for high blood pressure medication or failing to go to the doctor for diabetes, they are at risk of incurring more serious and costly problems that can land them in the emergency room.
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While large employers remain a strong and generous source of coverage, the Kaiser study pointed to the widening divide between employees working for big companies and those at companies with fewer than 200 employees.
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Virtually all large employers offered coverage, but only 62 percent of small companies did. People working for big companies were also paying less about $3,000 a year for family coverage compared with $4,100 for those in small companies.
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Faced with the choice of dropping coverage altogether, many small companies have opted for health plans that ask employees to pay much more in the form of deductibles and out-of-pocket expenses. One in three workers in small businesses has annual deductibles of $1,000 or more, in contrast to one in five in the previous year's survey.
From 9-25-08 New York Times, "Health Care Costs Increase Strain, Studies Find," By REED ABELSON.
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In a country where insurance is out of reach for many, it is not uncommon for couples to marry, or even to divorce, at least partly so one spouse can obtain or maintain health coverage.
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There is no way to know how often it happens, but lawyers and patient advocacy groups say they see cases regularly.
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In a poll conducted this spring by the Kaiser Family Foundation, a health policy research group, 7 percent of adults said someone in their household had married in the past year to gain access to insurance. The foundation cautions that the number should not be taken literally, but rather as an intriguing indicator that some Americans 'are making major life decisions on the basis of health care concerns.'
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In some instances, the need for insurance may prolong unhappy marriages.
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Other couples, like Michelle and Marion Moulton, are forced to consider divorce so that an ailing spouse can qualify for affordable insurance.
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Ms. Moulton, 46, a homemaker who lives near Seattle with her husband and two children, learned three years ago that she had serious liver damage, a side effect, she believes, of drugs she was once prescribed. She is trying to get on a transplant list, but the clock is ticking; her once slender body has ballooned, and her doctors say her liver could give out at any time.
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Two years ago, Ms. Moulton looked into buying more comprehensive coverage through the Washington State Health Insurance Pool, a state-financed program for high-risk patients. She found the premiums unaffordable, but noticed that the state offered subsidies to those with low incomes. As their debts and desperation multiplied, it occurred to Ms. Moulton that divorcing her husband of 17 years would make her eligible for the subsidized coverage.
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'I felt like I had done this to us,' she said. 'We had worked hard our entire lives, and if this was all the insurance we had, we could become homeless. I just said, You know, we really need to sit down and talk about divorce.' '
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'Nobody should have to make a choice like that,' Ms. Moulton said. 'What happened to our country? I don't remember growing up like this.'
From 8-13-08 New York Times, "Health Benefits Inspire Rush to Marry, or Divorce," By KEVIN SACK.
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Last week, [after many complaints by physicians] Zimmer announced it was suspending sales of the [hip socket replacement implants] device, known as the Durom cup, until it trained doctors how best to implant it. The company said a 'low' percentage of the 13,000 patients who got the socket would need replacements, but some doctors fear the number could reach into the hundreds.
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If those patients lived in other countries where artificial joints were tracked by national databases including Australia, Britain, Norway and Sweden many might have been spared that risk. And Zimmer might have suspended sales of the cup months ago.
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But the United States lacks such a national database, called a joint registry, that tracks how patients with artificial hips and knees fare. The risk in the United States that a patient will need a replacement procedure because of a flawed product or technique can be double the risk of countries with databases, according to Dr. Henrik Malchau of Massachusetts General Hospital.
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Experts say that the United States wastes billions of dollars annually on medical treatments which may not work. But the financial and human consequences are also large when evidence exists but is not collected.
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The toll of early device replacement is magnified here because of the sheer number of procedures that take place in the United States. Nearly one million hips and knees were used last year, about half of the world's total.
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'We are No. 1 both as a provider and user of implants,' said Dr. John J. Callaghan, a professor of orthopedics at the University of Iowa. 'We should be the leader in the follow-up of them.'
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The Food and Drug Administration is charged with monitoring devices like artificial joints. But that system is often overwhelmed by the vast number of products it monitors and because doctors often do not report problems.
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Medicare, which pays for about half the hip and knee implants in this country, rebuffed a proposal two years ago from a medical group to support a joint database. It said it was not the agency's job to gather such data despite the considerable savings in taxpayer dollars that might come from reducing the number of do-over surgeries.
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The use of joint registries has proven beneficial abroad. In Australia, regulators use such data to force manufacturers to justify why poorly performing hips or knees should remain available, and products have been withdrawn as a result. In Sweden several years ago, surgeons alerted by their national registry stopped using a badly flawed hip long before their American counterparts did. A few medical organizations here, like Kaiser Permanente, operate their own registries to good effect and the Hospital for Special Surgery in New York has recently set up a registry.
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But for more than a decade, efforts to set up an open national registry in this country have failed. One witness to those events has been Dr. Malchau, who worked for a decade at the Swedish registry. He and other registry advocates have heard all the reasons a registry cannot work here busy doctors hate paperwork, plaintiffs' lawyers would mine a database to find cases, general hospitals would be unfairly compared with specialty ones, to name a few.
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A registry for artificial joints is much like any system that can compare performance of competing cars or appliances, but in this case it involves appliances going into the human body.
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A patient identified by a number is entered into a database along with information about the device he or she received, the surgical technique used and the name of the doctor who performed the procedure. If a patient returns for a replacement, the information is recorded again, creating a rolling surveillance system.
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Such databases can be examined at any time for information and groups that operate national registries issue annual reports comparing performance of devices, differing surgical techniques and hospitals.
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Registries do not catch all problems and some registries have not been effective because not enough doctors participate. But the success of the Swedish program inspired Australian orthopedists to start their registry in the late 1990s through a professional association, said Dr. Stephen Graves, the program's director. Since then Australia's rate of early replacement procedures, or revisions, has declined.
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Confronted with registry data indicating problems, a 'significant percentage of companies will take the devices off the market,' Dr. Graves said.
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They may keep selling those devices elsewhere, including the United States.
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For several years, Dr. William Jiranek, an orthopedic surgeon in Richmond, has waged a lonely campaign for a registry in Virginia, one that has offered him a crash course in government, law and medical ethics.
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One of Dr. Jiranek's patients got the ball rolling in 2003 with a $50,000 donation. Then, the doctor, after learning that Virginia law needed to be changed to protect registry data, used some of that money to hire lobbyists who convinced lawmakers to do so. Soon, Dr. Malchau, the Swedish researcher now in Boston, helped provide software for doctors to enter data after a procedure.
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But now Dr. Jiranek is about to hit the hard part. Thus far, only six of the estimated 200 doctors doing joint replacements in Virginia are participating. 'Most of them are supportive,' Dr. Jiranek said. 'Few of them are willing to do a lot of work.'
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Dr. Jiranek's effort is the latest in a long series of attempts to create a registry in the United States. Even advocates acknowledge that the barriers to such a database are substantial.
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The American health care system is sprawling and fragmented, compared with the highly centralized systems in countries that do have the databases. Also, the number of orthopedic devices used here and the number of doctors implanting them is huge.
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Some registry advocates suspect there may be another reason why a registry has not gained urgency here the financial relationships between many orthopedists and device producers. Last year, several major manufacturers, including Zimmer and Smith & Nephew, agreed to pay $310 million to settle civil charges and resolve a Department of Justice investigation into whether the firms paid illegal inducements to get some doctors to use their products.
From 7-29-08 New York Times, "The Evidence Gap: A Call for a Warning System on Artificial Joints," By BARRY MEIER.
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With the Supreme Court becoming more conservative, many people who support women's right to choose an abortion fear that Roe v. Wade, the 1973 decision that gave them that right, is in danger of being swept aside.
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When such fears arise, we often hear about the pre-Roe 'bad old days.' Yet there are few physicians today who can relate to them from personal experience. I can.
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I am a retired gynecologist, in my mid-80s. My early formal training in my specialty was spent in New York City, from 1948 to 1953, in two of the city's large municipal hospitals.
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There I saw and treated almost every complication of illegal abortion that one could conjure, done either by the patient herself or by an abortionist often unknowing, unskilled and probably uncaring. Yet the patient never told us who did the work, or where and under what conditions it was performed. She was in dire need of our help to complete the process or, as frequently was the case, to correct what damage might have been done.
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Yet this much was clear: The woman had put herself at total risk, and literally did not know whether she would live or die.
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This, too, was clear: Her desperate need to terminate a pregnancy was the driving force behind the selection of any method available.
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The familiar symbol of illegal abortion is the infamous 'coat hanger' which may be the symbol, but is in no way a myth. In my years in New York, several women arrived with a hanger still in place. Whoever put it in perhaps the patient herself found it trapped in the cervix and could not remove it.
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Almost any implement you can imagine had been and was used to start an abortion darning needles, crochet hooks, cut-glass salt shakers, soda bottles, sometimes intact, sometimes with the top broken off.
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It is important to remember that Roe v. Wade did not mean that abortions could be performed. They have always been done, dating from ancient Greek days.
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What Roe said was that ending a pregnancy could be carried out by medical personnel, in a medically accepted setting, thus conferring on women, finally, the full rights of first-class citizens and freeing their doctors to treat them as such.
From 6-3-08 New York Times, "Essay: Repairing the Damage, Before Roe," By WALDO L. FIELDING, M.D.; Waldo L. Fielding was an obstetrician and gynecologist in Boston for 38 years. He is the author of 'Pregnancy: The Best State of the Union' (Thomas Y. Crowell, 1971).
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In February, the day after his infamous encounter at Washington's Mayflower Hotel, Eliot Spitzer, then the governor of New York, published a remarkable opinion piece in The Washington Post.
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He wrote that several years earlier, state attorneys general noticed a spike in predatory lending that the federal government was doing nothing about. When the states tried to rein in abusive mortgage lenders, the Bush administration finally did something. The Office of the Comptroller of the Currency issued rules nullifying state predatory lending laws over the objection of all 50 state banking superintendents.
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The clampdown, which paved the way for the subprime mortgage crisis, was done by 'pre-emption,' a little-understood doctrine that allows the federal government to wipe away state laws. The Constitution's supremacy clause says federal law can trump state law. But the federal rule should be a floor, not a ceiling. It should set a minimum level of rights, not stop states from doing more to protect their citizens.
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The Associated Press recently reported that the administration has quietly rewritten more than 50 proposed or adopted federal regulations to make it more difficult for consumers to sue makers of unsafe food, drugs and other dangerous products. The federal standard for head restraints in automobiles had language expressly saying it did not pre-empt state-court lawsuits but it was taken out. Manufacturers are more likely to make unsafe products if they know a customer who is injured or killed cannot sue.
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Most Americans may not know about the supremacy clause, but they do seem to understand that they are increasingly vulnerable. Weeks before the 2006 elections shifted control of Congress from the Republicans to the Democrats, 79 percent of respondents in an Opinion Research poll said big business had too much influence over the Bush administration. As Democrats and Republicans contemplate what kind of 'change' voters are looking for now, they can start with the idea that both the federal and state government need to do a better job of protecting their citizens.
From 5-23-08 New York Times, "Editorial Observer: What Ever Happened to (the Good Kind of) States' Rights?" By ADAM COHEN.
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Factory farming takes a big, hidden toll on human health and the environment, is undermining rural America's economic stability and fails to provide the humane treatment of livestock increasingly demanded by American consumers, concludes an independent, 2 1/2 -year analysis that calls for major changes in the way corporate agriculture produces meat, milk and eggs.
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The report released yesterday, sponsored by the Pew Charitable Trusts and Johns Hopkins Bloomberg School of Public Health, finds that the 'economies of scale' used to justify factory farming practices are largely an illusion, perpetuated by a failure to account for associated costs.
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Among those costs are human illnesses caused by drug-resistant bacteria associated with the rampant use of antibiotics on feedlots and the degradation of land, water and air quality caused by animal waste too intensely concentrated to be neutralized by natural processes.
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The report, "Putting Meat on the Table: Industrial Farm Production in America," comes at a time when food, agriculture and animal welfare issues are prominent in the American psyche.
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Food prices are rising faster than they have for decades. Concerns about global climate change have brought new attention to the fact that modern agriculture is responsible for about 20 percent of the nation's greenhouse-gas production. And recent meat recalls, punctuated by the release of undercover footage of cows being abused at a California slaughterhouse, have struck a chord with consumers.
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[Despite the benefit of cheaper meat] the system has brought unintended consequences. With thousands of animals kept in close quarters, diseases spread quickly. To prevent some of those outbreaks -- and to spur faster growth -- factory farms routinely treat animals with antibiotics, speeding the development of drug-resistant bacteria and in some cases rendering important medications less effective in people.
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It appears that the vast majority of U.S. antibiotic use is for animals, the commission noted, adding that because of the lack of oversight by the Food and Drug Administration and other agencies, even regulators can only estimate how many drugs are being given to animals.
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The commission urges stronger reporting requirements for companies and a phaseout and then ban on antibiotics in farm animals except as treatments for disease, a policy already initiated in some European countries.
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'That's a good recommendation. A strong recommendation,' said Margaret Mellon of the Union of Concerned Scientists, which released its own report last week documenting billions of dollars in farm subsidies to factory farming operations and annual federal expenditures of $100 million to clean up their ongoing environmental damage.
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The Pew report also calls for tighter regulation of factory farm waste, finding that toxic gases and dust from animal waste are making CAFO workers and neighbors ill.
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Activists said it will be up to Congress and agency officials, under public pressure, to implement some of the commission's recommendations. Congress is now considering a bill, the Preservation of Antibiotics for Medical Treatment Act, that would accomplish some of the Pew recommendations.
From 5-30-08 Washington Post, "Report Targets Costs Of Factory Farming," By Rick Weiss, Washington Post Staff Writer.
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The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.
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The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals.
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The lead author of Wednesday's article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry's published research, because the ghostwriting practice appears to be widespread.
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'It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician,' said Dr. Ross, whose article, written with colleagues, was published Wednesday in JAMA, The Journal of the American Medical Association. and posted Tuesday on the journal's Web site.
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The final work is the product of the doctor and 'accurately reflects his or her opinion,' said a Merck lawyer, James C. Fitzpatrick.
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And at least one of the doctors whose published research was questioned in Wednesday's article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that the article bearing his name was ghostwritten was 'simply false.' He said it was 'egregious' that Dr. Ross and his colleagues had done no research besides mining the Merck documents and reading the published journal articles.
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In an editorial, JAMA said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx.
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'It is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors,' the editorial said
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'The fact that the draft was written by a Merck employee for later discussion by all the authors does not in and of itself constitute ghostwriting,' Dr. Kirby's e-mail message said.
From 4-16-08 New York Times, "Merck Wrote Drug Studies for Doctors," By STEPHANIE SAUL.
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Only a tiny minority of drug trials on children have an independent safety monitoring committee to pick up potentially dangerous side-effects, a study has revealed.
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Researchers from Nottingham University found that under 2% of the 739 international drug trials published between 1996 and 2002 had such committees of independent experts who would scrutinise data and warn, if necessary, that it was not safe to carry on.
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Among the 2%, six trials had to be stopped early because of toxic effects on the child patients.
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'We were very surprised by the low level of trials that had independent safety monitoring committees and are urging pharmaceutical companies to include these in all future trials involving children,' said Dr Helen Sammons, associate professor of child health at Nottingham and lead author of the paper, published in the child health journal Acta Paediatrica.
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The team found that children experienced adverse effects caused by the drugs in a third of the trials - nearly 37%. In 11%, side-effects were moderate or severe and even sometimes life-threatening. Sammons stressed that the point of a trial was to find out whether the benefits of the drug outweighed any side-effects before the drug was used in the population at large.
From 3-18-08 The Guardian, "Study finds 98% of child drug trials lack independent safety checks," Sarah Boseley, health editor.
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"FEMA Knew Of Toxic Gas In Trailers: Hurricane Victims Reported Illnesses," By Spencer S. Hsu, Washington Post Staff Writer; from 7-20-07 Washington Post:
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The Federal Emergency Management Agency since early 2006 has suppressed warnings from its own field workers about health problems experienced by hurricane victims living in government-provided trailers with levels of a toxic chemical 75 times the recommended maximum for U.S. workers, congressional lawmakers said yesterday.
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A trail of e-mails obtained by investigators shows that the agency's lawyers rejected a proposal for systematic testing of the levels of potentially cancer-causing formaldehyde gas in the trailers, out of concern that the agency would be legally liable for any hazards or health problems. As many as 120,000 families displaced by hurricanes Katrina and Rita lived in the suspect trailers, and hundreds have complained of ill effects.
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On June 16, 2006, three months after reports of the hazards surfaced and a month after a trailer resident sued the agency, a FEMA logistics expert wrote that the agency's Office of General Counsel 'has advised that we do not do testing, which would imply FEMA's ownership of this issue.' A FEMA lawyer, Patrick Preston, wrote on June 15: 'Do not initiate any testing until we give the OK. . . . Once you get results and should they indicate some problem, the clock is running on our duty to respond to them.'
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On the eve of yesterday's hearing by the House Oversight and Government Reform Committee, FEMA reversed course on the issue and said it has asked federal health officials to help conduct a new assessment of conditions in trailers under prolonged use. But revelation of the agency's earlier posture -- in documents withheld by FEMA until they were subpoenaed by Congress -- attracted harsh bipartisan criticism.
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Some of the nation's most prominent spine surgeons hailed it as a medical breakthrough.
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In a study of nearly 240 patients with lower back pain, the doctors said that the Prodisc, an artificial spinal disk, had worked much better than conventional surgery in which patients' vertebrae were fused.
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'As a surgeon, it is gratifying to see patients recover function more quickly than after fusion and return to their normal activities more easily,' Dr. Jack E. Zigler, a well-known spine specialist and one of the study's lead researchers, said in a 2006 news release announcing the latest results of the Prodisc clinical trial.
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As it turns out, Dr. Zigler had more than a medical interest in the outcome. So did doctors at about half of the 17 research centers involved in the study. They stood to profit financially if the Prodisc succeeded, according to confidential information from a patient's lawsuit settled last year.
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The companies behind the disks and the surgeons who were willing to comment say the researchers' financial interests had no impact on findings of the research, which they say have been published in various peer-reviewed medical journals.
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In the study results submitted to the F.D.A., moreover, an unusually large number of patients were not included, and some of those patients have said they fared poorly. As a result, some patients and doctors critical of the research say the study may have cast the Prodisc in an overly flattering light.
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The way the Prodisc was tested and approved provides a stark example of conflicts of interest among clinical researchers conflicts that are seldom evident to doctors and patients trying to weigh the value of a new device or drug. Instead of serving as objective gatekeepers who can screen out potentially harmful or ineffective new devices or drugs, some medical experts say, clinical researchers with conflicts may have incentives to overstate the value of a new product for patients.
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For better or worse, doctors in this country frequently have financial ties to the companies whose devices or drugs they recommend to patients. But in the case of the Prodisc clinical trial, as with any clinical research, the doctors were supposed to be acting not as advocates for the product but as objective scientists studying whether the disk was safe and effective enough to be widely sold and used in the United States.
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Dr. Charles Rosen, a spine surgeon at the University of California, Irvine, was not involved in the Prodisc trial. But he provided his expert opinion to Patricia Kennedy's lawyers and has reviewed the medical records of some of the other patients who are dissatisfied with their treatment. He is among a growing number of specialists who say the relationships between some prominent spine surgeons and the device industry have become too cozy.
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'Industry's goal is to make a profit for its shareholders, not to advance medicine,' said Dr. Rosen, who in 2006 saw a need to start a group called the Association for Ethics in Spine Surgery. It now includes 85 specialists who say one of their aims is to warn the public about industry influence on medical practice.
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Few would argue that doctors should never be allowed to invest in promising new technologies. But when doctors are acting as researchers, they should not have money riding on the outcome, in the view of outside experts like Dr. Kevin A. Schulman, a professor of medicine and business at Duke University Medical Center who helps oversee clinical research there.
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The F.D.A.'s rules allow clinical investigators to have financial ties with the maker of the device or drug they are studying on the condition that such relationships are fully disclosed. Lawyers who have worked with the F.D.A. say that when it becomes aware of potential conflict, it tends to subject research to a higher level of scrutiny.
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The F.D.A. now says it is checking to see whether there was adequate financial disclosure information about the Prodisc researchers during the clinical trial and at the time that the subsequent application for approval was submitted.
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Close relationships between surgeons and device companies can affect more than the potential quality of an individual clinical trial, said Dr. Drummond Rennie, a professor of medicine at the University of California, San Francisco who has studied conflicts of interest among physicians. Because the entanglements are so common, Dr. Rennie said, it is unlikely another surgeon will speak out about any potential misgivings they have about any device.
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'The absolute ideal from a drug or device company is everyone is covered,' he said. 'And what they have it covered with is money.'
From 1-30-08 New York Times, "Financial Ties Are Cited as Issue in Spine Study," By REED ABELSON.
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Not long ago, I asked a respected cancer researcher if he could send me raw data from a trial he had recently published. He refused. Sharing data would make the study team members 'uncomfortable,' he said, as I might use this to 'cast doubt' on their results.
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I'd heard this before: as a statistician who designs and analyzes cancer studies, I regularly ask other researchers to provide additional information or raw data. Sometimes I want to use the data to test out a new idea or method of statistical analysis. And knowing exactly what happened in past studies can help me design better research for the future. Occasionally, however, there are statistical analyses I could run that might make an immediate and important impact on the lives of cancer patients.
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A few years back, a study was published showing that a certain drug could prevent one type of cancer. The problem was that the drug didn't work very well and had some side effects, so almost no one used it. At the same time, a colleague showed that a protein found in the blood could predict which patients were at high risk for cancer. We put two and two together and realized that we could use the protein test to work out which patients would benefit from the drug.
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To make things even easier for us, it turned out that the researchers who had conducted the trial had actually measured this protein in all their patients. So we wrote to them and asked whether they would share their data. They refused on the grounds that they might consider a similar analysis at some point in the future. But years have passed, no such analyses have been forthcoming and few patients are benefiting from what could be a very effective drug.
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Dr John Kirwan, a rheumatologist from the University of Bristol in England, has studied researchers' attitudes on sharing data from clinical trials. He found that three-quarters of researchers he surveyed, as well as a major industry group, opposed making original trial data available. It is worth restating this finding: most scientists doing research on how best to help those in pain, or at risk of death, want to keep their data a secret.
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Dr. Kirwan went on to ask his subjects why. Their reasons were entirely trivial: one cited the difficult of putting together a data set (wouldn't this have to be done anyway in order to publish a paper?); another was concerned that the data might be analyzed using invalid methods (surely a judgment for the scientific community as a whole). This is something of a clue that the real issue here has more to do with status and career than with any loftier considerations. Scientists don't want to be scooped by their own data, or have someone else challenge their conclusions with a new analysis.
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Yet this is exactly what cancer patients need. They want new results to be published as quickly as possible and to encourage a robust debate on the merits of key research findings.
From 1-22-08 New York Times, "Essay: Cancer Data? Sorry, Can't Have It," By ANDREW VICKERS; Andrew Vickers is a biostatistician at Memorial Sloan-Kettering Cancer Center in New York.
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