Is approximately 4 doctors, large group practice uses most electronic records system. In the majority of doctors for small offices, doctors provide most Americans patient illness and tracks, pen and paper and other issues.
Thousands Institute research 1999 in aggregate is life-threatening medical mistakes according to the report of the New England Journal of medicine recently North Carolina hospital in still all too common. Electronic records system itself attracts more and more computer errors, design flaws or failure of communication with patients to expose risk concerns.
For example, where the patient's electronic medical records disappeared or so wrong food and Drug Administration of patient files are stored. Incorrect entries sometimes drug allergies and blood pressure readings, agency says is provided.
These concerns a fresh look at the Institute of medicine, Committee run study came to patient safety and health information technology, and created a problem of the recommendations. 16 Member Panel on Tuesday in Washington for the first time meet has.
February, F D A... you had 260 received reports of malfunctions related health information technology "of the possibility of patient harm" to 44 contains six reported injuries and deaths reported 2008 and 2009, and is called. Malfunction their authority was reported primarily in the hospital.
May represent the tip of the iceberg because these reports are purely voluntary only, and Dr. Jeffrey Shuren, senior F... D... A... policies and enforcement official.
, Congress of show interest from Iowa, ranking, and Senate Finance Committee Republican party Senator Charles E. Grassley is to the health information industry Catherine Sebelius to was done to determine the Health Secretary, wrote the F D A..., the system checks the being was monitoring the patient safety concerns and what role, welfare, health information technology regulation to play are.
Proposed to consider the new safety requirements under the authority of the Agency to ensure the quality, such as Dr. Shuren F D A... regulator a set of safety, effectiveness, medical equipment, and software device.
"All the options to ensure the safety of the table to the" Dr. David Blumenthal, Obama administration National Coordinator of health information technology. Office Medical Institute Gail L. his the warden, gave the patient safety Panel, $ 989 k that Chief Executives rate in the health system President and Henry Ford Detroit.
Dr. Blumenthal Dr. Donald M / Berwick, Medicare and Medicaid administrators and Dr. Brent James, Intermountain Healthcare, Salt Lake City-based experts "agree to improve safety of care electronic health record" health information "
"The create, at any time to change the world risk at the same time," said Dr. Blumenthal, phone interview last weekend. We can implement to it, to realize the benefits of the safety of all, even if it is you want to see it, it is safe.
Institute of medicine "is ends if to ensure the safety regulations is an important part of this fabric we in all markets, the balance of regulation and innovation" and said
Was against the makers, system of long products Government regulations.
"Of by design agency, or any third party only after Shimo-subjects of policing are likely innovations suppression growth and development, now the Suppression of electronic medical records" and includes Charles Dvorak mentioned, Executive Vice President of epic and electronic record systems Permanente emperors and other large-scale medical and hospital group.
Recently avoided industry role and put it in the F... D... A..., statement for this article came in the healthcare information and management systems society, Washington industrial group, only ", on this complex issue of the Institute research and report back the future ask the medicine in the 12 months to the Government decision support that" said
Last month, one common way of protests in the American Medical Informatics Association "hold harmless" clause in many purchase contract unethical said. Clause usually allows the responsible for the manufacturers errors or misuse.
"We we said innovation, is worth more than safety and value of no" associated with Kenneth W., Goodman, said the Miami University bioethicist toward the Safety Advisory Group patients.
"We are in good data medical errors, not what the cause is" named Arthur A. Levin, new medicine Research Institute Committee members. -Mr. Levin, Director of New York, healthcare consumer Center 1999 report is, "in message that man," may 98, 000 preventable deaths, warned in hospitals each year were members of the Group of the Institute.
, Will be available may be electronic records is becoming without noticing the paper chart for more information about refers to the potential risk of the medical journal of New England last month's article, medical malpractice liability. Health care providers, a substantial initial costs and might quite the long-term benefits of uncertainty, Dr. Sandeep S / must weigh the risks to the Medical Center, New York University Langone Mangalmurti, physician, and his colleagues wrote.
"We probably about 2% of errors of prescription drugs, catch" Ross Koppel, Pennsylvania University sociologist and investigator RAND Corporation, Santa Monica, California, based on research organization "98% has got the error"
This article has been revised to reflect the following fix.
Correction: 12 / 15 / 2010
The previous version of this article is imprecisely Ross Koppel RAND Corporation quotes. In the prescription drug was approximately 2% of errors not all medical mistakes ??? said 2%.
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Take anesthesia drug-based drugs to reduce pain in patients arthritis and old bone is the risk of death when compared to take heart attack and those non-narcotic destroy are faced with high month day issued Government-funded survey.
As in the results of the first massive effort in research in archives of internal medicine, comparative safety risk taking painkillers different classes, find elderly. Narcotics Painkiller use these drugs except anesthesia drug advil and Motrin like older patient safety in recent years increasing for the current beliefs.
Federal healthcare quality and research institutions, loans, reviews, seems weaken the assumption. Basing the analysis of the patient's medical records, in the report was conducted by the Boston researchers Brigham and women hospital.
Researchers said in a telephone interview Daniel H. Monday, Solomon study, said do not "doctor opioid is a safer choice and other painkillers assumed". They seem appear to carry profound for a cardiovascular risk as well as increased fracture risk, and that is associated with increased risk of death.
Questions about the use of the powerful drug such as OxyContin does not occur in the treatment of pain caused by cancer or other criteria in the research.
To conduct studies on the Dr. Solomon detected during the period of 6 years and deformation osteoarthritis rheumatoid arthritis Medicare recipient NJ verified experience in both the State and Pennsylvania. Using statistical methods, researchers are those patients, mainly average age 80 year old woman, the divided into three groups according to pain medications.
Received one group patient anesthesia drug based painkiller. The second group, nonsteroidal anti-inflammatory drugs advil or Aleve was like. Pain called include the drug is not the third group is another class coxibs are celebrex Vioxx market was a drug.
Could not identify all factors that likely contributes to patient problems because based on the research record. However, researchers, overall risk death twice in taking nonsteroidal anti-inflammatory drugs turned out to be highly patients taking the Painkiller drug compared.
The Group of patients, drug 4 x composite bone fractures, was most likely high potential apparently the result of the fall, they twice a heart attack with. Risk of cardiovascular system posed by drug was the same and medicine has come under the scrutiny for celebrex and Vioxx, the danger.
Also reviews advil and Aleve at taking medicine for those taking the drug about the percentage of patients digestive tract bleeding turned out to be the same. Old medical expert patient advocate the drug, the principal reason is to alleviate these problems, beliefs.
Commentary, attached to the new report is the two doctors in Yale medical school, Dr. William C. Becker, Dr. Patrick G, O'Connor, such as bleeding wrote that over-the-counter painkillers errors may use undocumented patients about ulcer research findings. Added, however, high incidence of fatal complications, leads to the elderly, bone fractures, trouble was.
On Monday, public archives of medicine also posed by another drug-related research in the comparative risk looked Dr. Solomon and other researchers.
Use the same patient records cardiovascular tube risk codeine and the codeine was great, and drugs such as oxycodone, OxyContin, active ingredient hydrocodone, ??????? like drugs at the pose risks higher than the active ingredient mortality-related reports.
Food and move the heart risk reasons to stop narcotics Painkiller Drug Administration recently one, proproxyphene, sales. Drug was used in both Darvon and darvocet.
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In the study, published Tuesday by the New England Journal of Medicine, researchers found that the men taking Truvada, a common combination of two antiretroviral drugs, were 44 percent less likely to get infected with the virus that causes AIDS than an equal number taking a placebo.
But when only the men whose blood tests showed that they had taken their pill faithfully every day were considered, the pill was more than 90 percent effective, said Dr. Anthony S. Fauci, head of the infectious diseases division of the National Institutes of Health, which paid for the study along with the Bill and Melinda Gates Foundation.
“That’s huge,” Dr. Fauci said. “That says it all for me.”
The large study, nicknamed iPrEx, included nearly 2,500 men and was coordinated by the Gladstone Institutes of the University of California, San Francisco.
The results are the best news in the AIDS field in years, even better than this summer’s revelation that a vaginal microbicide protected 39 percent of all the women testing it and 54 percent of those who used it faithfully.
Also, Truvada, a combination of tenofovir and emtricitabine that prevents the virus from replicating, is available by prescription in many countries right now, while the microbicide gel is made in only small amounts for clinical trials.
The protection, known as pre-exposure prophylaxis, is also the first new form available to men, especially men who cannot use condoms because they sell sex, are in danger of prison rape, are under pressure from partners or lose their inhibitions when drunk or high.
It “does not involve getting permission from the other partner, and that’s important,” said Phill Wilson, president of the Black AIDS Institute, which focuses on the epidemic among blacks.
Michel Sidibé, the head of the United Nations agency that fights AIDS, called it “a breakthrough that will accelerate the prevention revolution.”
AIDS experts and the researchers issued several caveats about the study’s limitations, emphasizing that it looked only at gay men and Truvada. More studies, now under way, are needed to see whether the results can be duplicated, whether other antiretroviral drugs will work and whether they will protect heterosexual men and women, prostitutes and drug users who share needles.
There is no medical reason to think the pill would not work in other groups, since it attacks the virus in the blood, not in the vaginal wall as a microbicide does. Pre-exposure prophylaxis became possible only in recent years as newer, less-toxic antiretroviral drugs were developed.
Some scientists fear that putting more people on the drugs will speed the evolution of drug-resistant strains, though that did not occur in the study.
Because Truvada is available now, some clinicians already prescribe it for prophylaxis, Dr. Fauci said, but whether doing so becomes official policy will depend on discussions by the Centers for Disease Control and Prevention, the Food and Drug Administration, medical societies and others, which could take months.
Although the C.D.C. would prefer that doctors wait for further studies, more will probably prescribe the drugs now that this study is out, said Dr. Kevin Fenton, chief of the agency’s AIDS division, so the C.D.C. will soon release suggested guidelines.
The agency will suggest that the drug be prescribed only with close medical supervision and used only with other safe-sex practices.
“The results are encouraging, but it’s not time for gay men to throw away their condoms,” Dr. Fenton said.
AIDS advocacy groups were very excited by the results.
“If you comply with it, this works really well,” said Chris Collins, policy director of amfAR, the Foundation for AIDS Research. “This is too big to walk away from.”
Mitchell Warren, executive director of AVAC, an organization that lobbies for AIDS prevention, called the study “a great day for the fight against AIDS” and said gay men and others at risk needed to be consulted on the next steps.
In the study, 2,499 men in six countries — Brazil, Ecuador, Peru, South Africa, Thailand and the United States — were randomly assigned to take either Truvada or a placebo and were followed for up to three years. For ethical reasons, they were also given condoms, treatment for venereal diseases and advice on safe sex. There were 64 infections in the placebo group and 36 in the group that took Truvada, a 44 percent risk reduction.
Two in the Truvada group turned out to have been infected before the study began. When the remaining 34 were tested, only 3 had any drug in their blood — suggesting that the other 31 had not taken their pills.
Different regimens, like taking the pills not daily but only when sex is anticipated, also need testing.
Also, many men in the study failed to take all of their pills, and some clearly lied about it. For example, some who claimed to take them 50 percent or 90 percent of the time had little or no drug in their bloodstreams.
The pills caused no major side effects, though men who began to show signs of liver problems were taken off them quickly. Some men stopped taking the pills because they disliked relatively minor side effects like nausea and headaches. Also, some stopped bothering once they suspected that they might be taking a placebo.
“People have their own reasons,” Mr. Collins said. “People don’t take their Lipitor every day either.”
A major question now is who will pay for the drug.
In the United States, Truvada, made by Gilead Sciences, costs $12,000 to $14,000 a year. In very poor countries, generic versions cost as little as 40 cents a pill.
Globally, only about 5 million of the 33 million people infected with the AIDS virus are on antiretroviral drugs, and in an era of tight foreign-aid budgets, that number is not expected to rise quickly.
Hundreds of millions of Africans, Eastern Europeans and Asians are at risk and could benefit from prophylaxis, but that would cost tens of billions of dollars.
In this country, insurers and Medicare normally pay for the drugs, and the Ryan White Act covers the cost for the poor, but none of these payers yet have policies on supplying the drugs to healthy people.
No participant in the study developed resistance to tenofovir. Three were found to have strains resistant to emtricitabine, but investigators believe that all three were infected before the study began at levels low enough to have been missed by their first H.I.V. tests.
Another concern was that the participants would become so fearless that they would stop using condoms, but the opposite effect was seen — they used condoms more often and had fewer sex partners. But that can also be a result of simply being enrolled in a study and getting a steady diet of advice on safe sex and free condoms, the investigators said.
Other trials of pre-exposure prophylaxis have about 20,000 volunteers enrolled around the world. Their results are expected over the next two years.
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Patients with chronic kidney disease, the Vytorin, cholesterol was reducing the pill, a sixth fewer heart attacks, had to unlock strokes or operations your arteries than patients, a placebo, according to the results of a study on Saturday presented.
The main advantage was in reducing the risk of heart attacks and related deaths, but reduce the artery operations and certain types of strokes, according to data specialists this weekend in Denver shows that at a meeting of the kidney.
The difference in the operations to unlock arteries - 284 in the treated group compared with 352 in the placebo group - was statistically significant, said Dr. Colin Baigent, Professor at the University of Oxford and one of the two principal investigators of the study.
But the differences between the groups was statistically insignificant for major coronary events, er.Es were 213 of such events, including heart attacks and death in the group said the cholesterol pill that took compared with 230 in the placebo group. The study, although it was great, not enough people make a significant difference in heart attacks and related deaths demonstrate had taken, he said.
Cholesterol treatment had no significant impact in slowing the progression of disease, especially in reduce the need for patients to start dialysis or a Kidney transplant, get he said.
The five-year study called the sharp study, involved more than 9,000 patients assigned to randomized, placebo or Vytorin, a Merck medicine to take.Vytorin combined in a pill two different types of treatments - a statin simvastatin and a newer drug called Ezetimibe, aka known as Zyprexa-, that lower LDL or "bad" cholesterol.
The study by researchers of at Oxford of University coordinated and funded mainly by Merck, tested, whether patients with chronic kidney disease, with high risk for heart problems are sure of greatly reduced their bad cholesterol could benefit.
The Oxford researchers avoid an upbeat press release saying shipped, the combination pill to help people with chronic kidney disease could be 25% of all heart attacks, strokes and operations to blocked arteries, open a positive but more sober assessment Merck issued its own press release.
In an interview on Saturday, Dr. Baigent said his figure was extrapolation that takes into account the number of issues may be reduced if the drug took people how required - not the way in the study had handled both in the one-third and placebo patients stop to take your pills.
"" This is an important step forward for kidney disease,"said Dr. Baigent.""We have estimated that widespread use of lipid-lowering treatment in the prevention of heart attacks, strokes and operations arteries in 250,000 people would result in blocking" with chronic kidney disease every year.
But Merck said that the risk of non-fatal heart attack, stroke, cardiac death or artery Vytorin had reduced operations by around 16 percent compared to placebo, an analysis that included a wider variety of health problems on the basis of the originally specified objective.
Based on these results, Merck said regulators to approve Vytorin for patients with chronic kidney disease in a statement Saturday, questions planned,.
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A new study suggests women who are stressed out rather than other women, a heart attack at work or to have other forms of heart disease.
The findings at a meeting of the American Heart Association in Chicago, Nov.15 presented were based on data from 17,415 otherwise healthy women the middle age with the in the women's health study, sponsored by the national heart, lung and blood attended Institute.
The researchers found that a 40 percent increase in cardiovascular disease on all and one facing women load reported high job 88 percent at risk for heart attacks alone.("Burden" has been defined as demanding work with little power or ability to use the creativity and abilities).
Women concerned experienced an increase in heart disease about to lose a job, but you were more than women with high job security to be overweight or risk factors for heart disease have high blood pressure or high cholesterol.
Previous research on chronic job stress and heart disease in women had mixed results, although studies of predominantly male subjects have found a clear mapping between the two senior study author, Dr. Michelle A. said Albert, a cardiologist at the Brigham and women's Hospital in Boston and associate professor at Harvard Medical School.
"Cant get rid of stress, but can manage" said
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The study, conducted from 2002 to 2007 in 10 North Carolina hospitals, found that harm to patients was common and that the number of incidents did not decrease over time. The most common problems were complications from procedures or drugs and hospital-acquired infections.
“It is unlikely that other regions of the country have fared better,” said Dr. Christopher P. Landrigan, the lead author of the study and an assistant professor at Harvard Medical School. The study is being published on Thursday in The New England Journal of Medicine.
It is one of the most rigorous efforts to collect data about patient safety since a landmark report in 1999 found that medical mistakes caused as many as 98,000 deaths and more than one million injuries a year in the United States. That report, by the Institute of Medicine, an independent group that advises the government on health matters, led to a national movement to reduce errors and make hospital stays less hazardous to patients’ health.
Among the preventable problems that Dr. Landrigan’s team identified were severe bleeding during an operation, serious breathing trouble caused by a procedure that was performed incorrectly, a fall that dislocated a patient’s hip and damaged a nerve, and vaginal cuts caused by a vacuum device used to help deliver a baby.
Dr. Landrigan’s team focused on North Carolina because its hospitals, compared with those in most states, have been more involved in programs to improve patient safety.
But instead of improvements, the researchers found a high rate of problems. About 18 percent of patients were harmed by medical care, some more than once, and 63.1 percent of the injuries were judged to be preventable. Most of the problems were temporary and treatable, but some were serious, and a few — 2.4 percent — caused or contributed to a patient’s death, the study found.
The findings were a disappointment but not a surprise, Dr. Landrigan said. Many of the problems were caused by the hospitals’ failure to use measures that had been proved to avert mistakes and to prevent infections from devices like urinary catheters, ventilators and lines inserted into veins and arteries.
“Until there is a more coordinated effort to implement those strategies proven beneficial, I think that progress in patient safety will be very slow,” he said.
An expert on hospital safety who was not associated with the study said the findings were a warning for the patient-safety movement. “We need to do more, and to do it more quickly,” said the expert, Dr. Robert M. Wachter, the chief of hospital medicine at the University of California, San Francisco.
A recent government report found similar results, saying that in October 2008, 13.5 percent of Medicare beneficiaries — 134,000 patients — experienced “adverse events” during hospital stays. The report said the extra treatment required as a result of the injuries could cost Medicare several billion dollars a year. And in 1.5 percent of the patients — 15,000 in the month studied — medical mistakes contributed to their deaths. That report, issued this month by the inspector general of the Department of Health and Human Services, was based on a sample of Medicare records from patients discharged from hospitals.
Dr. Landrigan’s study reviewed the records of 2,341 patients admitted to 10 hospitals — in both urban and rural areas and involving large and small medical centers. (The hospitals were not named.) The researchers used a “trigger tool,” a list of 54 red flags that indicated something could have gone wrong. They included drugs used only to reverse an overdose, the presence of bedsores or the patient’s readmission to the hospital within 30 days.
The researchers found 588 instances in which a patient was harmed by medical care, or 25.1 injuries per 100 admissions.
Not all the problems were serious. Most were temporary and treatable, like a bout with severe low blood sugar from receiving too much insulin or a urinary infection caused by a catheter. But 42.7 percent of them required extra time in the hospital for treatment of problems like an infected surgical incision.
In 2.9 percent of the cases, patients suffered a permanent injury — brain damage from a stroke that could have been prevented after an operation, for example. A little more than 8 percent of the problems were life-threatening, like severe bleeding during surgery. And 2.4 percent of them caused or contributed to a patient’s death — like bleeding and organ failure after surgery.
Medication errors caused problems in 162 cases. Computerized systems for ordering drugs can cut such mistakes by up to 80 percent, Dr. Landrigan said. But only 17 percent of hospitals have such systems.
For the most part, the reporting of medical errors or harm to patients is voluntary, and that “vastly underestimates the frequency of errors and injuries that occur,” Dr. Landrigan said.
“We need a monitoring system that is mandatory,” he said. “There has to be some mechanism for federal-level reporting, where hospitals across the country are held to it.”
Dr. Mark R. Chassin, president of the Joint Commission, which accredits hospitals, cautioned that the study was limited by its list of “triggers.” If a hospital had performed a completely unnecessary operation, but had done it well, the study would not have uncovered it, he said. Similarly, he said, the study would not have found areas where many hospitals have made progress, such as in making sure that patients who had heart attacks or heart failure were sent home with the right medicines.
The bottom line, he said, “is that preventable complications are way too frequent in American health care, and “it’s not a problem we’re going to get rid of in six months or a year.”
Dr. Wachter said the study made clear the difficulty in improving patients’ safety.
“Process changes, like a new computer system or the use of a checklist, may help a bit,” he said, “but if they are not embedded in a system in which the providers are engaged in safety efforts, educated about how to identify safety hazards and fix them, and have a culture of strong communication and teamwork, progress may be painfully slow.”
Leah Binder, the chief executive officer of the Leapfrog Group, a patient safety organization whose members include large employers trying to improve health care, said it was essential that hospitals be more open about reporting problems.
“What we know works in a general sense is a competitive open market where consumers can compare providers and services,” she said. “Right now you ought to be able to know the infection rate of every hospital in your community.”
For hospitals with poor scores, there should be consequences, Ms. Binder said: “And the consequences need to be the feet of the American public.”
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Medical experts say the results, presented Sunday at the American Heart Association meeting, show there is a lesson to be learned about the effectiveness of small studies over all.
The drug, nesiritide, brand name Natrecor, was approved after small studies in carefully selected patients. It seemed to soothe a terrible heart-failure symptom — patients’ lungs fill with fluid and they feel as if they are drowning.
But the large study, with real-world patients, found no significant effect on that symptom.
A few years after its approval, nesiritide fell out of use because small studies seemed to indicate an increased risk of kidney problems and an increased death rate.
The large study showed those risks, too, were wrong.
“Once again, small studies give us the wrong answers,” said Dr. Robert M. Califf, a Duke cardiologist who directed the large study. “There was no safety issue at all.”
“To me, the really important message is that the drug got very widely used for reasons that are incorrect, and then it got bashed for reasons that are incorrect,” Dr. Califf said. “Unless we do these kinds of large clinical trials we are engaged in a comedy of errors,” he added.
The question of how to evaluate rare side effects that seem to arise in small studies plagues medical researchers. Most drug studies are not designed to assess rare effects, but as more drugs are sold to huge numbers of people who often take them for years, the question has become increasingly pressing.
The nesiritide story began in 2005, four years after the drug was approved. At first it was popular, but then researchers, in two analyses, asked if it was really safe. They had lumped together data from several nesiritide studies. One analysis reported damage to kidney functions, and the other found increased death rates. Sales plummeted.
Johnson & Johnson, the drug’s maker, put together an expert panel that said the only way to answer the safety question was to do a large study. That led to the study that Dr. Califf directed, which enrolled anyone who came to any of 450 participating hospitals around the world with heart failure and complaining of difficulty breathing. Participants were randomly assigned to get an infusion of nesiritide or saline. Researchers asked two main questions: Were the patients still alive a month later? And were they readmitted to the hospital?
The study’s executive committee is still debating what to conclude, Dr. Califf said. No one thinks the drug should be pulled from the market, he added, because some patients may get breathing relief even though the drug was not effective for the participants as a whole.
“But the major message is that if you don’t do the right studies you just don’t know” about risks and benefits, Dr. Califf said. “And you are at risk of making serious errors.”
Cardiologists have similar questions about the effectiveness of Zetia, an eight-year-old cholesterol drug that Dr. Califf is also studying. It has been beset by doubts about whether it improves heart health.
The Food and Drug Administration approved Zetia, which lowers LDL, or “bad” cholesterol, in 2002. In 2004, the agency approved a related drug called Vytorin, which combines Zetia and a statin called simvastatin.
Both are made by Merck. Together, they have had worldwide sales of $26.8 billion, according to IMS Health, a firm that tracks drug sales, and have been taken by millions of Americans.
But eight years after Zetia came on the market, many cardiologists say they still don’t know whether taking Vytorin is better for the heart than using a statin alone.
That is because statins like Crestor, which work by blocking the production of cholesterol in the liver, have proven to cut the risk of cardiovascular problems. Zetia, however, acts differently; it works in the gut, where it inhibits the absorption of cholesterol from food. Zetia alone modestly reduces bad cholesterol, and the combination pill significantly reduces LDL.
But studies so far have failed to demonstrate a cardiac benefit to the drugs. Now there is a new Zetia study, due to be presented this week at a kidney conference in Denver, which looked at whether the combined pill reduces heart attacks and strokes in patients with kidney disease, who are at high risk for heart problems.
But the study is unlikely to resolve the Zetia question because it did not involve a group of patients taking a statin alone. Doctors still won’t know whether the combined pill works better than statins, which are available as inexpensive generics.
To try to answer the health-benefit question, Merck has sponsored one of the largest clinical trials ever conducted on cholesterol drugs. The trial, which started in 2005 and is due to be completed in 2013, involves about 18,000 patients at 1,046 sites around the world. It is taking years to complete because researchers set a goal of tallying 5,200 major cardiovascular problems in order for the project to end, said Dr. Luciano Rossetti, the head of global scientific strategy at Merck Research Laboratories.
“I don’t see a problem with the timing considering what it takes to do a trial like this,” Dr. Rossetti said. “I think it is great that we are committed to finding out that answer.”
Dr. Califf, who is one of two principal investigators on the Zetia trial, said it was common for the main outcomes study to lag years behind the approval of a drug, but he said the practice was a problem for doctors who practice evidence-based medicine.
“F.D.A. by mandate could require studies, but that wouldn’t be necessary if clinical trialists and academic medical centers stuck to their guns and demanded the evidence before they used the drugs on a wide scale,” he said, referring to both Zetia and nesiritide.
Drug makers also bear a responsibility to conduct rigorous studies before they start widely promoting medications, he added.
“Huge amounts are spent on marketing that could have been spent on a clinical trial,” he said.
This article has been revised to reflect the following correction:
Correction: November 15, 2010
???An earlier version of this article misstated the number of trial sites in Merck's study of cholesterol drugs. It is 1,046, not 380.
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Marijuana smoking often begins in adolescence - and the timing could not be worse, suggests a new study.
Young adults who began the drug use regularly in their early teens assessment function of the brain as subjects at least 16 were significantly worse on cognitive tests when started performed smoking, scientists reported on Monday.
The findings presented at the annual meeting of the society for Neuroscience in San Diego, led researchers at the McLean Hospital to suspect that the young people developing brain can be particularly vulnerable to the negative effects of marijuana.
"We must understand that the developing brain is not the same as the adult brain," said Dr. Staci A. Gruber, the paper the senior author and Director of the cognitive and clinical neuroimaging section of cerebral Imaging Center at the McLean, a Harvard-affiliated hospital in Belmont, Massachusetts.
The study relating to brain scans, was small, consisting of chronic from 35 marijuana smokers who were on average 22 years old. Smoking marijuana had begun twenty, regularly before the age of 16, during 15 began regularly at the age of 16 smoking or higher.All had similar levels of education and income.
The subjects were asked to an assessment of the Executive function - the brain processes responsible for planning and abstract thinking and understanding rules and inhibition inappropriate Aktionen.Der test - where participants were asked to sort cards with different shapes, numbers and colors - is a measure of cognitive flexibility, the ability to stay focused, follow responses rules and control impulsive.Dr. Gruber said those who began smoking marijuana at younger ages significantly lower on the test as those evaluated, the smoking later started in their teen years.She got correct less card sorting categories and more errors were gemacht.Sie also very much more likely to said their mistakes to give wrong answers, even after they were wrong to repeat.
15 Dr. Gruber, said, the brain is still changing and "the part the Executive function of the last part is modulated to develop."
There are other significant differences between the two groups of Raucher.Diejenigen the marijuana have been regularly use in their early teens had smoked more than twice as often as those smoking later begonnen.Die smoked early users also 14.7 grams per week, almost three times as much as the later smokers, 5.9 grams per week on average used said Dr. Gruber.
She attributed to still performance drive to legalizing marijuana in many countries age limits should contain the task for the early use of marijuana, not the more geraucht.Das, she added.
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Stuart Bradford
Are lung cancer scans really ready for prime time?
News that annual CT lung scans can reduce the risk of lung cancer death among former and current heavy smokers was celebrated by national heath officials this month. A major government study found the screening scans saved the life of one person for every 300 current or former smokers who were scanned.
But now cancer and screening experts are worried that the limited findings will be used by private screening centers to promote the test to a broader group than was studied. That, in turn, could lead to thousands of unnecessary lung scans, causing excess radiation exposure and unnecessary biopsies and surgery.
Dr. Otis W. Brawley, chief medical officer of the American Cancer Society, said he was stunned to hear a radio advertisement for an Atlanta screening center cite the study just a few days after the government had announced the results. The wording of the ad seemed to be aimed at a broad group, ranging from heavy smokers to women who had never smoked, Dr. Brawley said.
“We really need to weigh the harms associated with screening,” he said. “The scientific community still needs to digest this. To take a trial that involves people at high risk for lung cancer and to extrapolate it and say it’s good for people with intermediate or low risk is not appropriate.”
The study, called the National Lung Screening Trial, focused on a specific high-risk group: 53,000 current and former heavy smokers, aged 55 to 74, who had smoked for at least 30 pack-years. That means someone who smoked one pack a day for 30 years, two packs a day for 15 years or three packs a day for at least 10 years would qualify for the study.
Former smokers who had accumulated 30 pack-years were included only if they had stopped smoking within the previous 15 years.
The smokers and former smokers were given either annual CT lung scans or chest X-rays. Compared with conventional X-rays, the CT, or computed tomography, scans create a detailed three-dimensional image of the lungs. The study was stopped when it was found that the scanning group had a 20 percent lower risk of dying from lung cancer than those being screened with X-rays.
But the early results also showed a downside of scanning: one of every four lung scans showed an abnormality, which often led to additional worry, radiation exposure from follow-up scans and, sometimes, lung biopsies and even risky surgery. But because the study was stopped early, a full analysis of the harms caused by screening scans is still months away.
Reading the scans is tricky because harmless nodules can be misinterpreted as suspect lesions. In the study, even experienced radiologists at major cancer centers had a high rate of false positives, suggesting that the rate would be even higher in the real world.
“There is a learning curve to reading spiral CTs,” Dr. Brawley said. “I’m concerned that some radiologists might be early in that learning curve and some patients may be harmed because of it.”
While the study found a benefit to scanning a specific group of high-risk smokers, that doesn’t mean other groups will get the same benefit, says Dr. Peter B. Bach, a pulmonologist at Memorial Sloan-Kettering Cancer Center in New York. In lower-risk groups, for instance, it’s likely that thousands of people would need to be exposed to the risks of screening before a single life was saved. And it’s possible that many of those scanned unnecessarily could be seriously harmed.
“The aggregate harms to all the people’s lives who are not saved have to be taken into account,” Dr. Bach said. “Even in these highly controlled settings, about 1 percent of the people had surgery or a part of their lung removed for something they thought was cancer and it wasn’t.”
Low-dose CT scans expose patients to about the same radiation levels as mammograms.
For now, most consumers who want a scan will have to pay for it themselves, although it is expected that insurance companies eventually will approve scanning for those in high-risk groups. (Medicare officials have indicated that they will soon reconsider paying for the screening tests.) The government has estimated the cost at about $300 a scan, but some centers may charge $1,000 or more.
The day the government announced the study results, Westside Medical Imaging of Beverly Hills, Calif., issued a press release saying that the study “should once and for all settle the controversy” about whether CT lung scans save lives.
In the release, Dr. Norman E. Lepor said the scans were an “indispensable” part of annual exams for patients who have smoked for 10 years.
In an interview, Dr. Lepor said that he only offers lung scans to those at high risk, and that he turns people away who are at low risk but want the scan anyway because “they just want to know.”
Dr. Lepor said it would be “imprudent” not to incorporate the latest study data into his practice right away.
“There are people who, with good conscience and their take of the data, say it’s not ready for prime time, and there are people who look at the same data and they come to other conclusions,” Dr. Lepor said. “This is not the first study that has supported screening. We know from our own anecdotes that we have saved a lot of lives.”
Dr. Lepor said that he had just met a woman who had smoked for 50 years and was concerned about her risk. “She’s the poster person for this test,” he said.
Dr. Brawley said he’s worried that the few early press releases and radio advertisements are just the beginning of widespread promotion of screening lung scans.
“It was sort of ominous to be working Sunday evening in my home office and this thing comes on the radio,” he said. “A lot of people run out when there is a new announcement and get the new test. We’re very frightened some people are going to be harmed because of this.”
A version of this article appeared in print on Nov. 16, 2010, on page D5 of the New York edition of The Times.
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More bad news about post-menopausal hormone therapy: a new European study reported that, to take hormones significantly increased risk of ovarian cancer are's women rarely but often deadly.
Findings from the European prospective investigation into cancer and nutrition that some 126,920 post-menopausal women included, were at a Conference of the American Association for cancer research presented this week in Philadelphia.
After nine years follow-up 424 ovarian cancer had diagnostiziert.Sogar after controlling for body mass index, smoking and several other risk factors, the researchers found that women, post-menopausal hormone therapy had 29 percent higher risk of ovarian cancer than women not using hormones.
Women hit, facing an increased risk of 63 percent over estrogen used only hormone therapy, after a hysterectomy, not consumers during the increased risk of ovarian cancer in women, with a combination of estrogen and progestin not statistical significance.
Yet, said study author, Konstantinos k. Tsilidis, a cancer epidemiologist at the University of Oxford's cancer epidemiology in England, it was a clear increase in the risk for current user all hormones, but only if you had used hormones for at least five years.
"" It is important that the message out to women ", said Dr. Tsilidis."This is a very fatal cancer."
The number of women hormone therapy dropped after a large trial funded by the national institutes of health, find that hormones has increased the risks of stroke and blood clots, and that the combination therapy increases the risk of breast cancer and heart attacks. many women still, hormones use to treat menopausal symptoms, although you get the lowest dose for as short a period a time as possible to take.
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The findings represent to enormous advance in cancer detection that could potentially save thousands of lives annually, although at considerable expense. Lung cancer will claim about 157,000 lives this year more than the deaths from colorectal, breast, pancreatic and prostate cancers combined.Most patients discover their disease too late for treatment, and 85 percent from it.
No. screening method had proved effective at reducing mortality from the disease.Four randomized controlled trials done during the 1970s showed that chest x-rays, while they helped catch cancers at an earlier stage, had no effect on overall death rates.Since then, researchers have suggested that CT scans, which use coordinated x-rays to provide three dimensional views--could detect lung tumors at at even earlier stage than x-rays.
"This is the first time that we have seen clear evidence of a significant reduction in lung cancer mortality with a screening test in a randomized controlled trial," said Dr. Christine Berg of the National Cancer Institute.
Cancer doctors and others predicted that the study's results would soon lead to widespread use of CT scans, in particular for older smokers who have a one in 10 chance of contracting lung cancer.
"These people are worried about lung cancer, and now there is an opportunity to offer them something," said Dr. Mary Reid, associate professor of oncology at the Roswell Park Cancer Institute in Buffalo.
But health officials involved in the study refused to endorse widespread screening of current or former smokers, saying more analysis of the study's results is needed to further identify who benefited most. Such an analysis is months away. And they pointed out that the study offers no Réassurance about the safety of smoking or the advisability of CT scans for younger smokers or nonsmokers.
"No. one should come away from this thinking that it's now safe to continue to smoke," said Dr. Harold E. VARMUS, director of the National Cancer Institute.
Patients wishing to get a CT lung screen will most likely have to pay roughly $300 charge themselves, since few insurers pay for such scans unless an illness is suspected.The federal Medicare program will soon reconsider paying for such screens, a Medicare official said.
The study, called the National Lung screening trial, was conducted by the American College of Radiology Imaging Network and the cancer institute. It involved more than 53,000 people ages 55 to 74 who had smoked at least 30 pack years - one pack a day for 30 years or two packs a day for 15 years. Ex-smokers who had quit within the previous 15 years were included in the group.
Each what given either a standard chest x-ray of or a low - dose CT scan at the start of the trial and then twice more over the next two years.Participants were followed for up to five years. There were 354 lung cancer deaths among those who received CT scans and 442 among those who got X rays. The $250 million study, which began in 2002, was paid for by the cancer institute and carried out at 33 sites.
Its preliminary results were announced days after an independent monitoring board determined that the benefits of CT scans were strong enough to stop the trial. The study will be published in the coming months.
The study found that for every 300 people who were screened, one person lived who would otherwise have died during the study. But one quarter of those given CT scans were found to have anomalies, nearly all of which were benign.These false signals generally led to more worry, more CT scans and sometimes to lung biopsies and thoracic surgery.
"There are economic, medical and psychological consequences of finding these abnormalities," Dr. VARMUS said.
Deaths due to all causes declined by 7 percent among study participants who received CT scans, suggesting the tests helped to detect other life-threatening diseases besides lung cancer.
Dr. Claudia Henschke, a clinical professor of radiology at Mount Sinai Medical Center and a longtime advocate for use of CT to screen for lung cancer, said the study was likely to have underestimated the benefits of CT scans because participants were screened only three times. Had the screening continued for 10 years, as many as 80 percent of lung cancer deaths could have been averted, she said. Dr. Henschke's research has been controversial because of its statistical methods and its financing, which included money from a tobacco company.She earns royalties from makers of CT machines.
"What we also have found is that low - dose CT scan gives information on cardiovascular disease, emphysema" and other pulmonary diseases, Dr. Henschke said."Those are the three big killers of older people.""There is just tremendous potential."
But Dr. Edward F. Patz, Jr., professor of radiology at Duke who helped put the study, said hey what far from convinced that a thorough analysis would show that widespread CT screening would prove beneficial in preventing most lung cancer deaths.Dr. said that Patz the biology of lung cancer has long suggested that the size of cancerous lung tumors tells little about the stage of the disease.
"If we look at this study carefully we may suggest that there is some benefit in high-risk control, but I'm not there yet," Dr. Patz said.
Since smoke 46 million people in the United States and tens of millions more once smoked, a widespread screening program could cost billions annually.Any further refinement of those most at risk could reduce those costs.Low-dose CT scans expose patients to about the same radiation levels as mammograms.Little is known about how the cumulative risks of years of such scans would balance the benefits.
The study's results could have both legal and political consequences.Suits against tobacco companies have sought to force cigarette makers to pay for annual CT screens of former smokers.But with the science uncertain, those claims have so far been rebuffed.Congress has diverted some research money to create pilot CT lung screening programs, diversions that may gain momentum now.
Some Obama administration officials f.d.a. during the debate on the health care law that patients' health was often harmed by getting too many tests and procedures that, if reduced, would improve health while reducing costs.This study suggests that, at least in lung cancer, spending more on tests saves lives.
Laurie Fenton, president of the Lung Cancer Alliance, which has lobbied for widespread CT lung screening, said the debate about the advisability of such scans is now over.
"The challenge now shifts from proving the efficacy of the method to developing the proper quality standards, infrastructure and guidelines to bring this needed benefit to those at high risk for the disease - now," Ms. Fenton said.
But Dr. Peter B. Bach, a pulmonologist at Memorial Sloan-Kettering Cancer Center in New York, said no one should rush out and get a CT scan yet because further analysis will better define whom the screening helped.
"Very soon we'll have an answer about who should be screened and how frequently," Dr Bach said, "but we don't of have that answer today."
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Immune system may help cancer cells hide: studyLast Updated: 2010-10-29 11:51:11 -0400 (Reuters Health)By Maggie FoxWASHINGTON (Reuters) - Cancer cells may find a hideout in the body's immune system, researchers said on Thursday in a study that may help explain why tumors can come back after rounds of toxic chemotherapy.
Tests on mice showed that the stress of chemotherapy drives some tumor cells into the thymus, the gland that produces immune cells known as T-cells.
The gland bathes these rogue tumor cells with protective agents, the researchers at the Massachusetts Institute of Technology reported in the journal Cell. The findings suggest that cancer treatments need to attack this hiding place.
"Successful cancer therapy needs to involve a component that kills tumor cells as well as a component that blocks pro-survival signals," MIT's Michael Hemann said in a statement.
"Current cancer therapies fail to target this survival response."
Hemann and colleagues tested mice with a type of cancer called Burkitt's lymphoma. They were treated with doxorubicin, a standard chemotherapy drug.
The drug worked, as expected -- the tumors regressed. The mice were killed and examined.
"To analyze the effect of drug treatment on specific tumor niches, we harvested all primary lymphoid organs, including peripheral lymph nodes, thymus, spleen and bone marrow, following doxorubicin treatment," the researchers wrote.
Most of these were clear, too -- except for the thymus. In fact, there were more tumor cells in the thymus after chemotherapy than there had been before.
"Thus, the thymus represents a chemoprotective niche that protects lymphoma cells from doxorubicin-induced cell death," the researchers wrote.
Mice genetically engineered to have tiny and dysfunctional thymuses survived better when infected with Burkitt's lymphoma and then treated, so it appeared the thymus was doing something to protect the tumor cells.
Lab tests suggested that the thymus secretes chemicals that protect immature cells from toxins, and the cancer cells were just taking advantage of this, Hemann said.
More tests will be required to see if the same thing happens in people, they said, but it may be necessary to attack certain immune system compounds such as IL-6 and one called Bcl2.
SOURCE: http://link.reuters.com/qeg92q Cell, online October 29, 2010.
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