A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.
Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.
Based on its knowledge of the heart attack risks, GlaxoSmithKline "had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner," the report said.
Instead, the company tried to downplay findings that the drug could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks, it said.
GlaxoSmithKline said in a statement the drug is safe. It said the committee report took data out of context from analyses of Avandia.
In May 2007, the New England Journal of Medicine published an analysis of dozens of studies on nearly 28,000 people who had taken Avandia. The journal said there was a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication. The findings raised concerns because two-thirds of the people with Type 2 diabetes, the most common form, die of heart problems.
Later that year, the FDA ordered a warning to be included on Avandia's label warning that it might increase the risk of heart attacks. But the label also says data on the risks are inconclusive.
"Contrary to the assertions in the report, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events," GlaxoSmithKline said.
In a letter to FDA Commissioner Margaret Hamburg that was also released Saturday, the senators said the documents the committee reviewed included an analysis conducted by two safety officials at the agency. The analysis compared Avandia to Pfizer Inc.'s Actos diabetes drug, and found that Avandia has an increased risk of heart attack and heart failure.
The letter also quoted the researchers as saying that said the study itself was dangerous, as it meant patients continued to take the drug.
FDA spokesman George Strait said the FDA is reviewing new data on Avandia and will present those findings to an advisory committee this summer.
"Meanwhile, Commissioner Hamburg is reaching out to ensure that she has a complete understanding and awareness of all of the data and issues concerning this drug," Strait said.
http://apnews.myway.com//article/20100220/D9E04G700.html
Saturday, February 20, 2010
Friday, February 19, 2010
Do We Really Want the Status Quo on Health Care? - NICHOLAS D. KRISTOF, NYTimes.com
If you found a suspicious lump in your neck, you'd never put off dealing with it with the excuse: This is the loveliest neck in the world, and I don't want to tinker with it.
Sure, hospitals are expensive and serve tasteless food. Yes, surgeons can accidentally leave a clamp behind, and nobody likes blood. But burying one's head in the sand is what ostriches do — and that's what we Americans are poised to do if we miss this chance to reform our sick health care system.
The debate about health care in recent months has focused on the shortcomings of the reform proposals. Critics are right to be disappointed that the legislation doesn't curb malpractice suits and doesn't do more to change the basic fee-for-service structure that incubates rising health care costs.
But just think for a moment about the far costlier option that now may lie ahead of us: sticking with the status quo.
Health care is on my mind partly because my eldest son, a champion high school wrestler, had his latest postmatch encounter with the medical system. You know you have a problem when the E.R. nurse immediately recognizes your son and discusses whether hospitals should give kids the equivalent of frequent flier miles.
Thirteen stitches and a serious infection crisis later, my son is on the mend. He had the help of an excellent, committed pair of doctors, his pediatrician and an oral surgeon. But for tens of millions of Americans who are uninsured or underinsured, medical care is haphazard and sometimes nonexistent.
And every indication is that the longer we stick with the existing system, the worse the problems will be with the two central and interlinked problems of our health care system, access and cost.
For a peek at what to expect, consider that California's Anthem Blue Cross — the largest for-profit health insurance company in America's most populous state — is explaining that it is "sound and necessary" for it to raise rates for individual insurance by up to 39 percent. The increase, originally scheduled for March, is now scheduled to take effect in May.
Critics doubt that the Senate and House bills would succeed in containing health care costs very much, and they may be right. It's hard to know. But the existing system is a runaway roller coaster. Isn't it prudent to try brake pedals even if we're not sure how well they'll work?
The United States Public Interest Research Group calculated last year that without reform, insurance premiums for those with employer-provided health care would nearly double by 2016. Also last month, the Urban Institute applied its computer model of health insurance costs to a scenario in which there is no reform, and this is what it found:
"Over the next decade in every state, the percent of the population that is uninsured will increase, employer-sponsored coverage will continue to erode, spending on public programs will balloon, and individual and family out-of-pocket costs could increase by more than 35 percent," it said. It added that the number of uninsured Americans could reach as many as 65 million in another decade.
As The New England Journal of Medicine noted last month, the United States ranks No. 1 only in terms of spending. We rank 39th in infant mortality, 43rd in adult female mortality and 42nd in adult male mortality.
Skeptics suggest that America's poor health statistics are a result of social inequities and a large underclass. There's something to that. But despite these problems, the population over age 65 manages to enjoy above-average health statistics — because it enjoyed health care reform back in 1965 with Medicare.
The medical journal noted that "comparisons also reveal that the United States is falling farther behind" other countries each year. In 1974, for example, Australian men and boys aged 15 to 60 died at about the same rate as American men and boys in that age group. Today, Australia's rates for that group are about 40 percent lower than America's.
"U.S. performance not only is poor at any given moment but also is improving much more slowly than that of other countries over time," the medical journal reported.
So don't believe the canard that health reform is unaffordable. Last year, we spent 17.3 percent of gross domestic product on health care, about double what many other industrialized countries pay. The share is rising by more than one-quarter of a percentage point per year.
At the present rate, by my calculations, in the year 2303 every penny of our G.D.P. will go to health care. At that time, we'll probably get daily M.R.I.'s and CAT scans, even as we starve naked in caves.
So the question isn't: Can we afford to reform health care? Rather: Can we afford not to?
Thursday, February 18, 2010
The Cost Conundrum Persists: Atul Gawande, The New Yorker
A New York Times article I just read suggests that a data set I used in my piece "The Cost Conundrum" has been questioned. Not so. A recent opinion piece in The New England Journal of Medicine does take issue with a particular analysis offered by the Dartmouth Atlas of Health Care. But it doesn't dispute the Dartmouth data I drew on.
As readers may recall, my article investigated why Medicare spent markedly more for its enrollees in McAllen, Texas, than in most of the country—in 2006, the region had higher medical spending per beneficiary than anywhere except Miami. The poverty and poor health of the people in this border community proved to be part of the story. But El Paso was just as poor and unhealthy, and health care there cost half as much per Medicare enrollee (approximately seventy-five hundred dollars versus fifteen thousand dollars in 2006) while providing levels of quality that measured, if anything, higher. The patterns of Medicare spending I found showed that McAllen's medical community and culture simply did more—more surgery, more imaging, more specialist visits, more home-nursing visits—without clear benefit. The lesson was that more is not necessarily better. And, indeed, communities with some of the best quality measures for health care have among the lowest costs in the country for their elderly Medicare patients—communities like Grand Junction, Colorado, and Rochester, Minnesota, where the Mayo Clinic is the dominant medical institution.
The article has had an impact that is still surprising. It led to numerous proposals from across the political spectrum to hold hospitals and clinicians more accountable for reducing overtreatment, undertreatment, and mistreatment of patients. Much of the data for the article came from the Dartmouth Atlas, which is an independent resource, maintained for three decades by researchers at Dartmouth University, that analyzes Medicare data in dozens of ways. Given the attention my article directed toward its work, and the financial stakes involved, its research has faced tremendous scrutiny. But none of the data used in the article has been found erroneous or wanting.
The particular topic of the New England Journal opinion piece that the Times reported on—how hospital efficiency is measured—is, as the newspaper acknowledges, arcane. But if one wishes to try to reward hospitals that provide higher quality for lower cost, one needs to be able to distinguish between high- and low-efficiency hospitals. Dartmouth researchers have come up with a way to rate hospital efficiency, including for costs in the last year of patients' lives. In the opinion piece, Dr. Peter Bach of Memorial Sloan-Kettering argues against using the Dartmouth measures to financially reward and penalize hospitals. There is a healthy and vital debate about how best to change hospital incentives. None of this, however, calls the Dartmouth researchers' decades of highly respected work—or their fundamental findings—into question. If anything, the debate reinforces the importance of their research.
There remains fierce disagreement about how much of the marked differences in spending between communities is the result of health differences between populations and how much is the result of differences in the care their clinicians provide to them. But it remains clear that there are substantial variations in the cost of care for people of similar health depending on which institutions they go to—and also that clinicians with the best results often have lower, not higher, costs than average.
Even if health reform disappears, these fundamental problems will not. The cost conundrum persists.
Tuesday, February 16, 2010
A life of constant pain - The Irish Times
DOCTORS REFER to it as "the silent epidemic" and it accounts for half of all sick days taken from work and billions of euros each year in GP visits and expensive medicines.
Up to a third of us will at some point in our lives suffer chronic pain, according to the statistics.
The International Association for the Study of Pain (IASP) defines it as pain that lasts longer than three months, but other definitions simply characterise it as pain that persists after healing has taken place.
While some sufferers have a recognisable disease process like arthritis or diabetes, others have musculo-skeletal pain, most typically lower backache, often with no discernable cause.
It has also been shown that post- operative pain which is not well managed can develop into chronic pain.
Apart from the pain itself, the condition can seriously impair a sufferer's ability to perform routine tasks, and impact negatively on their work life.
It is also strongly linked to poor health, in particular a higher incidence of obesity.
The psychological stress of persistent pain can make people depressed, and it is often cited as a cause of relationship breakdown.
Unlike acute pain, which serves to warn the body of danger or potential injury, chronic pain has no particular function, explains consultant anaesthetist and pain management specialist Dr Ken Patterson.
"With persistent or ongoing pain, changes occur in the central nervous system and the spinal cord that can be difficult to reverse, and which can go on to form their own disease entity," he says.
So when patients have persistent acute pain, Patterson says, they can go on to develop "chronic pain syndromes".
"One of the things we see with chronic pain is that the nerve or pain pathways continue to fire even after tissue damage has healed."
Patterson admits it is not fully clear why this is happening to some people.
"But there is strong evidence to suggest that the continued assault on the spinal cord of untreated acute pain can lead to a chronic pain state."
Musclo-skeletal injuries often involve neuropathic pain arising from nerve tissue damage, which can be subtle and difficult to discern, as distinct from nociceptive pain which originates from injury or disease outside the nervous system.
Several US studies indicate the brain not only receives pain signals from the spinal cord but also undergoes changes in neural pathways that may permanently strengthen its reactions to those signals.
Experts believe these changes are key to the onset of chronic pain.
Patterson also believes there is a genetic component to chronic pain, citing a number of studies on mice which indicate a "predisposition to chronic pain states" in animals.
The Health Service Executive (HSE)and Health Research Board (HRB) are currently funding a two-year study into chronic pain in Ireland.
The preliminary findings of the Prime study (Prevalence, Impact and Cost of Chronic Pain in Ireland), conducted by a team at NUI Galway, found one in three people reported having chronic pain for an average of seven years, with many reporting significant suffering and reduced quality of life.
Unlike several international studies, which suggest chronic pain affects a higher proportion of women than men, the NUI study found no significant difference between the sexes.
Unsurprisingly, the survey found the lower back was the most common site of pain, followed by the knee, neck and shoulder.
Research co-ordinator at NUI Galway, Dr Brian McGuire, says the most typical cause of pain in the under-65 population was lower back pain, but in over-65s it is knee pain.
"We also found the incidence of pain increases with age, with 28.2 per cent reporting pain in the 18-34 age group, increasing to 50 per cent in those aged 65 and over," he says.
In broad terms, pain is defined by the ISAP as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage".
The definition indicates there is a lot more to pain than just the sensory experience. The emotional state of the person at the time of the pain experience has been shown to affect how they perceive the pain.
While some chronic pain sufferers will be treated with basic analgesic medicines, most pain management physicians believe a more inter- disciplinary approach, taking in occupational therapies and cognitive behavioural therapies (CBT), is more suitable.
Pain management programmes in the US typically involve a team of specialists from psychologists, physiotherapists and pain doctors to rheumatologists and geriatricians.
Limerick-based consultant in pain medicine Dr Brendan Conway believes pain medicine in Ireland, especially outside the main centres, often lacks such a multidisciplinary approach.
"Patients need to have a full understanding of pain, so they can deal with the psychological aspects of pain that we can't deal with through medication," Conway says.
Addressing "negative pain behaviours" such as lack of physical activity or poor sleep patterns, through cognitive behavioural therapy, can significantly improve a patient's quality of life and, in many cases, stop people falling apart, he says.
In oncology, Conway says, psychologists are successfully used to help patients deal with aspects of cancer pain or cancer therapy, but the equivalent in standard pain medicine is often lacking.
The over-reliance on pain medication harbours its own problems, often undermining pain management and leaving patients at risk of addiction.
A recent US study also found the risk of overdose in patients prescribed opioids for chronic pain was strongly associated with the dose that they had been prescribed.
The study, published last month in the Annals of Internal Medicine, assessed the risk of overdose in patients prescribed opioids for chronic non-cancer pain. It linked the risk of fatal and non-fatal opioid overdose to prescription use.
Doctors back 'right to die'
Euthanasia is already a reality in Quebec hospitals, the president of the federation of Quebec medical specialists, told a National Assembly committee yesterday.
Doctors know when death is "imminent and inevitable," Gaétan Barrette explained.
But doctors are aware they can be charged with murder if they administer a "palliative sedative" before a patient is on his or her last breath.
Geoffrey Kelley, chairman of the committee, explained that MNAs will hear about 30 expert witnesses on "dying with dignity" to prepare a paper for a travelling public consultation this fall.
Barrette told the committee the issue of euthanasia could not be discussed in Quebec 50 years ago, comparing it with the evolution in thinking about abortion.
"Doctors are ready to debate euthanasia," Barrette said. And like abortion, he said, limits must be established. Not every patient will want euthanasia and not all doctors will agree to perform the procedure.
Barrette explained that a patient who is lucid consults with a doctor, friends and family members before requesting euthanasia.
For patients who are not lucid, a biological will can guide relatives who must decide.
The patient could have a terminal disease, like cancer. And patients at the "end of life" could be babies born with serious medical difficulties or seniors whose bodies are shutting down, one system after another.
"It's a cascade," Barrette said. "We can't invent it. We see it. There are safeguards."
Barrette said palliative care, using opiates to ease the pain, is also an important facet of end-of-life care.
"The choice of the patient is his choice," he said. "We want legislation in tune with the wishes of the public."
Polls indicate a high percentage of Quebecers favour euthanasia, including doctors.
But Barrette and Yves Lamontagne of the Quebec College of Physicians told the committee that doctors do not want to perform assisted suicides.
"We are not there to execute people," Lamontagne said.
Euthanasia, the decision to end life when death is imminent and inevitable, is "extremely complex and emotionally charged," Lamontagne added.
Yves Robert, secretary of the College, told the committee that Quebec is the only jurisdiction in Canada where patients can refuse medical treatment, which can lead to death.
"It doesn't exist elsewhere in Canada," Robert said. "We are ahead. Can we go farther?"
Handling of seizures on TV medical dramas often wrong, study finds
Television medical dramas can be misleading when it comes to the proper way to deal with epileptic seizures or convulsions, say researchers, who have found that small-screen doctors and nurses do it incorrectly more than half the time.
In a study by Dalhousie University, researchers screened all episodes of the top medical shows, including "Grey's Anatomy," "House," "Private Practice" and the last five seasons of "ER."
Of 327 episodes, there were almost 60 examples of patients experiencing seizures or convulsions, said lead investigator Andrew Moeller, a third-year medical student at the Halifax university. Of those, most took place within hospital settings on the shows and were treated by "nurses" or "doctors."
The study found that in 25 cases - about 46 per cent - the story line had health providers giving first aid for seizures in an inappropriate manner, said Moeller, who screened all 327 episodes of the medical shows. Proper treatment was shown in 17 seizures, or about 29 per cent of the time, while appropriateness could not be determined in 15 cases, or about 25 per cent of the total.
"What we characterized as inappropriate handling of it was trying to stop someone's seizing movements, trying to hold the person down or sticking something in their mouth," he said from Halifax.
"What you should be doing is clearing the area of harmful objects. If it's possible, rotate the person onto their side to keep them from hurting themselves - it's called the recovery position - and if possible put something soft under their head."
"And once they're finished the seizure, just staying with the person until they recover their full consciousness."
Moeller, who conducted the study with Halifax neurologist Dr. Mark Sadler, said the concern is that viewers who are unaware of the proper way to give first aid to someone having a seizure will take their cue from what they see on TV.
"And (they could) inadvertently hurt someone when they're actually trying to help someone."
More ...
Monday, February 15, 2010
The Checkup - Gallbladder surgery deaths rare
U.S. Rep. John Murtha's death yesterday from complications following gallbladder surgery he had in January was a very rare occurrence. According to the American College of Surgeons, among generally healthy people undergoing such surgery, deaths occur in only 0 to 1 per 1,000 patients.
Murtha, 77, reportedly was readmitted to the hospital Jan. 31 after his earlier surgery; it turned out his large intestine had been damaged during the removal of his gallbladder. Murtha's surgery was said to be laparoscopic, a minimally invasive approach that's become the standard of care in most hospitals, rather than the more invasive "open" surgery.
Hartford, Conn. surgeon Peter Bloom, who removed my own stone-ridden gallbladder 13 years ago, says no randomized, clinical trial has ever pitted the two approaches against one another, so it's really not known whether one is safer than the other. Still, the risks each poses are pretty much the same.
First are the general risks associated with any surgery, Bloom explains. Problems such as stroke, heart attack, blot clots traveling to the lungs and causing a pulmonary embolism, infection and problems with anesthesia are common to both procedures. These complications "might do someone in in a day," Bloom says. A patient's age and overall health can affect the risk of complications from gallbladder removal or any other surgery, he adds.
Other complications specific to gallbladder surgery often take longer to make themselves apparent, Bloom says. These include injury to the bile duct, intestine or liver.
When I told Dr. Bloom that I don't remember hearing about any of those risks before my surgery, he laughed and said nobody ever remembers. But he says he sits down with every patient before scheduling surgery and goes over a booklet that includes the full list of potential complications. "It's frightening, and part of it is in unfamiliar language," Bloom says, noting that he doesn't recall being told the risks of surgery he himself has received, so eager was he just to get on with the procedure.
"Most people just want to get better," Bloom says. And, thankfully, most do.
Murtha death raises questions over preventable medical errors - POLITICO.com
The death Monday of Rep. John Murtha (D-Pa.) after complications from gallbladder surgery raises questions about whether the lawmaker was among the nearly 100,000 people who die in U.S. hospitals annually due to preventable medical errors.
With the ongoing debate in Washington about the nature of health care reform, Murtha's passing shines light on one area that hasn't had enough scrutiny, how to make our health care system safer. As the American health care system has been labeled by some as the most advanced in the world, others are critical of the fact that so many people die in hospitals annually due to preventable medical errors.
It's not just about the cost to the health care system to deal with the errors, but the needless number of lives lost. This system-wide failure was highlighted over a decade ago in the Institute of Medicine (IOM) report "To Err Is Human: Building a Safer Health System."
Questions about circumstances surrounding the death of Murtha, the longtime Defense Appropriations chairman and confidante to House Speaker Nancy Pelosi - viewed from afar without specific knowledge of his medical condition - are likely to heighten a long-running debate among medical practitioners and others.
According to the Washington Post, Murtha had elective laparoscopic gallbladder surgery performed at the Bethesda Naval Hospital and fell ill shortly afterwards from an infection related to the procedure. Murtha was hospitalized to Virginia Hospital Center in Arlington, Va., to treat the post-operative infection. His care was being monitored in the intensive care unit (ICU), a sign that suggests that not only was the infection becoming widespread but also that vital organ systems were shutting down.
Was his death preventable or simply unavoidable? A 2009 study by the University of Maryland Medical Center notes that when gallbladder surgery is performed electively "the mortality rates are very low. (Even in the elderly, mortality rates are only 0.7 - 2%.)"
Perhaps Murtha, 77, was one of the unlucky 2 out of 100 to have died from this elective surgery. It is also equally likely that he died of a medical error or omission.
As Dr. Atul Gawande notes in his newest book, "The Checklist Manifesto," in his experience a simple list has helped prevent less-than-optimal surgical outcomes. One item on the list was whether or not IV antibiotics were given at the time the surgeon began the opening incision. You would think this would be obvious, as in the operating room there is a surgical team that as a group is responsible for the patient's care. Do they work as a highly functioning team? Are there clear lines of communications between the surgeon, anesthesiologist, nurses, and surgical techs?
Sadly, communications are not as clear as they need to be. As Gawande notes, a simple two minute checklist not only forced communications (something as basic as an introduction to the surgical team – "Hi, I'm Dr. Gawande general surgeon") but also verified that critical tasks were completed. As a result, the checklist decreased the complication rates by 36 percent and death rate by half. Disappointingly only 20 percent of American hospitals have adopted these types of checklists.
Bethesda Naval Hospital, as a government institution, is not included in surveys by the respected Leapfrog Group, an organization that works to reduce preventable medical mistakes and rates hospitals on their processes to keep patients safe. (Leapfrog Group was founded by large employers, who purchase health insurance, to evaluate the care their employees receive from hospitals).
Virginia Hospital Center, where Murtha was hospitalized, didn't submit any information either even though it is listed in the Leapfrog Group database. Specifically, Virginia Hospital Center declined to respond to the survey on how they are doing to keep medical errors from occurring. Questions include whether there is adequate ICU staffing, processes to reduce ICU infections, and steps to prevent harm. Gawande notes in his earlier New Yorker piece that even intensive care units errors of omission and missed opportunities happen that can be avoided with checklists.
Even now, as Gawande points out, getting doctors and hospitals to improve patient safety with something as basic as a checklist has been extraordinarily difficult. And it's symptomatic of a broader problem in our health care system, unforced errors that can be fatal.
Davis Liu, M.D., is a practicing board-certified family physician in Roseville, Calif., and author of "Stay Healthy, Live Longer, Spend Wisely – Making Intelligent Choices in America's Healthcare System."
To Err Is Human: Building a Safer Health System
Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDS--three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems.
To Err Is Human breaks the silence that has surrounded medical errors and their consequence--but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agenda--with state and local implications--for reducing medical errors and improving patient safety through the design of a safer health system.
This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes.
Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errors--which begs the question, "How can we learn from our mistakes?"
Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care.
To Err Is Human asserts that the problem is not bad people in health care--it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocates--as well as patients themselves.
To Err Is Human breaks the silence that has surrounded medical errors and their consequence--but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agenda--with state and local implications--for reducing medical errors and improving patient safety through the design of a safer health system.
This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes.
Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errors--which begs the question, "How can we learn from our mistakes?"
Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care.
To Err Is Human asserts that the problem is not bad people in health care--it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocates--as well as patients themselves.
Bedside Bad Manners | Health Care | Change.org
"Wordlessly, I said to him, 'You fucking bastard," John McPhee writes in this week's New Yorker. His vitriol was directed at a young doctor with a staggering lack of bedside manner who had just informed McPhee that his father was on the verge of death. What the doctor was thinking, we don't know. But based on recent articles written by doctors on the subject of bedside manner, the feeling may have been mutual.
McPhee's article is ostensibly about fishing for chain pickerel, but includes a description of the aftermath of his father's stroke. "I was startled by the candor of the doctor," McPhee writes. "He said the patient did not have many days to live, and he described cerebral events in language only the patient, among those present, was equipped to understand. But the patient did not understand: 'He can't comprehend anything, his eyes follow nothing, he is finished,' the doctor said, and we should prepare ourselves." The Health Policy and Communications blog points out that this doctor mistakenly neglected to include the family in his "continuum of care."
McPhee likely wouldn't get any comfort from Dr. Alex Smith, an assistant professor at UC San Francisco, or Dr. Mark Morocco, an associate professor at UCLA Medical Center and the former medical supervisor for ER. Each has picked up a pen (or pounded the keys, as it were) to offer insight into what doctors are thinking when they treat us. The result is more revealing, and certainly more controversial, than anything a physician would say on the ward. Also, I have a feeling that these doctors have excellent bedside manner, by virtue of their willingness to write transparently about the topic.
"Many people, including me, vary the language we use depending on our recommendation for treatment," Smith writes. He made me laugh when he described the intricate lingual game that patients and doctors play when discussing resuscitation. Below are some examples of questions he asks patients, followed in parenthesis by the answer he secretly desires:
"Would you like us to restart your heart if it stopped beating?" (Please say yes) (I'm just asking as a formality)
"Would you like to allow us to let you to die naturally?" (Saying no goes against nature) (We have an unnatural power over life and death)
"Would you like us, in what would naturally be your final moments, to press on your chest and break your ribs, shove a tube down your throat and poke you with needles in lots of places in a chaotic attempt that has a very small chance of giving you more time to be technically alive but unlikely to ever return to meaningful communication with others?" (Please say no) (CPR is horrific) (I don't want to have to do this to you)
Morocco wrote just as plainly: "From time to time, all doctors want to kill their patients." He described a perfectly awful patient he once treated just as he was finishing med school. "I wanted to kill Mr. Martinez. ... Not your bureaucratic, passionless, Sarah Palin-invented 'government death panel' killing, but a personal, pillow-wielding, Cuckoo's Nest-style snuffing out of Mr. Martinez's candle by the only person left in his life who was still willing to talk to him."
In the years since, I bet Morocco has met patients and family members, like McPhee, with Cuckoo's Nest tendencies of their own.
Sunday, February 14, 2010
Personalized medicine - Wikipedia, the free encyclopedia
The United States Congress defines personalized medicine as "the application of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, and help determine a person's predisposition to a particular disease or condition."[1] Traditionally, much of medical practice relies on standards of care based on epidemiologic studies of large cohorts. This approach to evidence-based medicine has revolutionized medicine during the past 50 years. However, results from large population-based studies are not always applicable to a specific individual, and physicians generally take into account specific characteristics—such as age, gender, height, weight, diet, and environment—when evaluating an individual patient.
Recent developments in a number of molecular profiling technologies, including proteomic profiling, metabolomic analysis, and genomic/genetic testing allow the development of personalized medicine and predictive medicine, which is the combination of comprehensive molecular testing with proactive, personalized preventive medicine. It is hoped that personalized medicine will allow health care providers to focus their attention on factors specific to an individual patient to provide individualized care. However, some question whether personalized medicine represents a true departure from traditional medical practice or is an evolutionary transition based on the latest technology.[2]
The overarching concept that underpins personalized medicine is that information about a patient's protein, gene or metabolite profile could be used to tailor medical care to that individual's needs. A key attribute of personalized medicine is the development of so-called companion diagnostics, whereby specific molecular assays that measure levels of proteins or genes or specific mutations are used to stratify disease status, select from among different medications and tailor dosages, provide a specific therapy for an individual's condition, or initiate a preventative measure that is particularly suited to that patient at the time of administration.
The field of oncology currently is feeling the greatest impact of personalized medicine. Several examples of companion diagnostic tests that now are necessary to obtain before cancer-based therapy include measuring for the erbB2 and EGFR proteins for selecting breast, lung and colorectal cancer patients for specific targeted therapies. As the personalized medicine field advances, tissue-derived molecular information will be combined with an individual's personal medical history, family history, and data from imaging, and other laboratory tests.
The field of personalized medicine raises many ethical issues, business opportunities, humanitarian opportunities, and some challenges.
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The Counterfeiter - The Scientist - Magazine of the Life Sciences
Now, he thought he finally had an entrée to the US market. His contact, going under the name "Mr. Ed," was a bald, middle-aged man with a sketchy background in the clothing business. Ed ran a company based in Houston, Texas called Tri State Distributors. Back in March, Xu and his wife, Jennifer, met Ed at the Starbucks in the Bangkok airport. Xu promised he could deliver orders of 100,000 pills if Ed gave him time to prepare. One month after that meeting, Xu shipped $5720 worth of drug samples, including 130 boxes of Zyprexa, the Eli Lilly drug for bipolar disorder, to Tri State's headquarters in a bleak office park a short drive from George Bush Intercontinental Airport. If all went according to plan, these drugs would end up on pharmacy shelves where the biggest profits await.
Then, the email arrived. It was probably the first significant stumbling block in what was so far Xu's flawless career. "One of my customers called," Ed wrote in a message to kevinxl07@gmail.com, "and said there is a recall of Zyprexa in Europe with the same lot number. I am trying to find out more on the Internet. Have you heard anything? We will cancel the Zyprexa order until we find out the problem lot number."
That day, the United Kingdom's drug agency had pulled the drug from pharmacy shelves after a tip from a wholesaler. Analysis revealed that the pills contained just 75% of the active ingredient.ï¾ The agency later recalled two other drugs: the Sanofi-Aventis anticlotting medication, Plavix, and the AstraZeneca prostate cancer medication Casodex. Xu had given Ed both medicines, which would turn out to be subpotent and contain high levels of impurities. They were counterfeits.
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http://www.the-scientist.com/article/display/57108/
Do-It-Yourself Genetic Engineering - NYTimes.com
A City College team worked on the project all summer. Then in October, five students flew to Cambridge, Mass., to present it at M.I.T. and compete against more than 1,000 other students from 100 schools, including many top-flight institutions like Stanford and Harvard. City College offers courses in everything from linear algebra to an introduction to chairside assisting (for aspiring dental hygienists), all for an affordable $26 a credit. Its students were extreme but unrelenting underdogs in the annual weekend-long synthetic-biology showdown. The competition is called iGEM: International Genetically Engineered Machine Competition.
The team's faculty adviser, Dirk VandePol, went to City College as a teenager. He is 41, with glasses, hair that flops over his forehead and, frequently, the body language of a man who knows he has left something important somewhere but can't remember where or what. While the advisers to some iGEM teams rank among synthetic biology's leading researchers, VandePol doesn't even teach genetic engineering. He teaches introductory human biology — "the skeletal system and stuff," he explained — and signed on to the team for the same reason that his students did: the promise of this burgeoning field thrills him, and he wanted a chance to be a part of it. "Synthetic biology is the coolest thing in the universe," VandePol told me, with complete earnestness, when I visited the team last summer.
http://www.nytimes.com/2010/02/14/magazine/14Biology-t.html?ref=magazine&pagewanted=all
http://www.nytimes.com/2010/02/14/magazine/14Biology-t.html?ref=magazine&pagewanted=all
Does Pregnancy Affect Memory? - Motherlode Blog - NYTimes.com
When I was pregnant with my first child, I went off to the mall one day to buy baby things. All went smoothly at the first stop, but at the second I left the package I was carrying from store one. I remembered to take my purchase from store two, but then forgot that purchase at store three. This went on about half a dozen times with me retracing my steps across The Galleria for much of the afternoon.
As I retrieved each purchase, the saleswomen were reassuring. After all, they worked at places like Baby Gap and Pea in a Pod; they had seen this before. Don't worry, they said with poorly veiled amusement. It's "pregnancy head." Or "baby brain." Or "mumnesia."
It is also — possibly — a myth. According to this month's issue of The British Journal of Psychiatry pregnancy does not make you forgetful. It makes youthink you are more forgetful because you are already worried about memory loss, theorizes Helen Christensen, the researcher from Australian National University who led the study.
And the reason you might be worried is because prior studies have linked pregnancy, parenting and forgetfulness. But those were based mostly on self-reporting by women during pregnancy and did not compare cognitive performance before, during and after.
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