2009 Archives
2009 Archives:
Patient Safety
AMI Patients Get 30% of Annual Maximum Recommended Radiation Dose in One Hospital Admission “Kaul told heartwire , "We certainly don't want to be alarmist. We're trying to change the way people think about radiation. . . . We're not suggesting that appropriate or necessary testing be withheld, but we're trying to reinforce the need for physicians to carefully evaluate the indications, so that when they do order tests that involve radiation, they consider decreasing the dose based on the admitting diagnosis." Kaul added that the findings of this study suggest a need for better efforts to track a patient's radiation dose throughout the diagnostic process.”
Case review finds 31% error rate among local imaging services
ER crowds mean longer waits, even for the very ill “Waits of five to six hours have become the norm, Dr. Melissa L. McCarthy of Johns Hopkins University School of Medicine in Baltimore, the study's lead author, told Reuters Health. And the arrival of flu season -- with not just one, but two, strains to worry about -- has only made things worse, she added. … In their commentary -- Dr. Jesse M. Pines of the University of Pennsylvania in Philadelphia and Dr. Donald M. Yealy of the University of Pittsburgh School of Medicine --say ER patients have become "the unfortunate 'canaries in the coal mine' in a dysfunctional health care system."”
How Accurate Are Hospital Report Cards? “Researchers cited several other problems with rating systems. For example, report cards typically lump neurology and neurosurgery into one category, neurosciences. "Although both services treat many of the same pathological processes, their performance at any given institution is by no means shared," researchers wrote. "This can be misleading if the neurology aspects of the rating system misrepresent the neurosurgical service or vice versa." Another common practice is using reputation as one of the main ranking criteria. This practice "is at best subjective," researchers wrote. Researchers wrote that misleading information in report cards and rakings "may falsely direct patients and their families to hospitals providing a lower level of neurosurgical care, or direct them away from hospitals providing a high level of neurosurgical care."“
How Much Evidence Do We Need to Change Practices in Which We Firmly Believe? “In the first major trial (done in the 1960s) of tight glucose control in patients with type 2 diabetes, oral glucose-lowering agents were associated with higher cardiovascular mortality and no differences in microvascular complications compared with placebo.1 Insulin also was not associated with clinical benefit. In three recent large randomized trials (ACCORD,2 ADVANCE,3 and VADT4), tight control in patients with long-standing type 2 diabetes did not lower overall mortality, cardiovascular-related mortality, stroke, amputations, or even clinical (as opposed to surrogate) microvascular endpoints. Differences in specific outcomes in these trials might be related to different treatments or to duration of diabetes in participants. In some studies, fewer intensively treated patients reached composite outcomes (such as "any diabetes complications"), but the bulk of improvement was in nonclinical outcomes (e.g., incident albuminuria). Tight control was associated with severe hypoglycemia and weight gain. In the UKPDS study,5 published a decade ago, nonobese intensively treated participants with newly diagnosed type 2 diabetes were less likely to reach microvascular endpoints (including "need for photocoagulation," but not visual loss) but showed no difference in mortality (cardiovascular, diabetes-related, or all-cause) compared with nonobese control patients. Among obese participants, metformin alone lowered long-term mortality and myocardial infarction rate, but sulfonylureas and insulin did not; tight control did not lessen risk for microvascular complications. Metformin and sulfonylureas in combination were associated with excess diabetes-related deaths and all-cause mortality. Because trials do not support tight control and because of the cost, burden, and harms associated with tight control, we should be emphasizing cardiovascular risk reduction (particularly control of blood pressure and cholesterol levels) and healthy lifestyles for patients with type 2 diabetes.6“
Recent archived links on top:
H1N1 Flu Safety and Ingredients Discussion:
Squalene-based adjuvants in vaccines (WHO)
Summary of: WHO Virtual Consultation on the Safety of Adjuvanted Influenza Vaccines
Thimerosal, squalene and Guillain-Barré: Expert answers to your seasonal and H1N1 flu questions
Blogs:
http://remixxworld.blogspot.com/2009/10/h1n1-swine-flu-trial-vaccine-contains.html
http://knowthelies.com/?q=node/4324
From Novartis Vaccines (Pharmaceutical Company):
MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis.
---------------------------------------------Review: Reports on Pfizer drug studies misleading “In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn't disclosed at all. The authors cited some limitations to their review, including not knowing who made the changes. "We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees," the researchers wrote. Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, called the report "one of the most ethically disturbing papers I've read in some time" and "an indication that people have been playing fast and loose with studies," particularly industry ones.”
Steroids' risks can equal their healing benefits
Study Finds 52 Percent Lower Chance Of Dying At Top-rated Hospitals
Study raises new questions about Merck pill Zetia “In the study, Zetia failed to shrink buildups in artery walls while a rival drug, Niaspan, did so significantly. Zetia users also suffered more heart attacks and other problems although the numbers of these events are too small to draw firm conclusions. Zetia "has been on the market for about seven years and we still haven't proven that it improves clinical outcomes," said Dr. Roger Blumenthal, preventive cardiology chief at Johns Hopkins University.”
FDA Warns of Radiation Overexposure With Brain CT “The US Food and Drug Administration (FDA) is reporting cases of radiation overexposures during brain perfusion computed tomography (CT) imaging. The overexposures took place at a single institution but may reflect a more widespread problem regarding CT quality assurance programs. During an 18-month period, the agency found that 206 patients received radiation doses that were approximately 8 times the expected level. According to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program, "If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects." Patients received 3 to 4 Gy instead of the expected 0.5 Gy (maximum) to the head, the FDA notes. "In some cases, this excessive dose resulted in hair loss and erythema."”
Compliance with hand hygiene on surgical, medical, and neurologic intensive care units: Direct observation versus calculated disinfectant usage. ( Am J Infect Control. 2009) “BACKGROUND: Hand hygiene (HH) is considered the single most effective measure to prevent and control health care-associated infections (HAIs). Although there have been several reports on compliance rates (CRs) to HH recommendations, data for intensive care units (ICUs) in general and for shift- and indication-specific opportunities in particular are scarce. … Worrisomely, CRs were very low, especially concerning indications of greatest impact in preventing HAIs, such as before aseptic task.”
Fumbled Handoffs Can Lead To Medical Errors “Poor communication of the outcomes of medical tests whose results are pending at the time of a patient's hospital discharge is common and can lead to serious medical errors in post-hospitalization medical treatment.”
Glycemic control in type 2 diabetes: time for an evidence-based about-face? (Ann Intern Med. 2009) “Some diabetes guidelines set low glycemic control goals for patients with type 2 diabetes mellitus (such as a hemoglobin A(1c) level as low as 6.5% to 7.0%) to avoid or delay complications. Our review and critique of recent large randomized trials in patients with type 2 diabetes suggest that tight glycemic control burdens patients with complex treatment programs, hypoglycemia, weight gain, and costs and offers uncertain benefits in return. We believe clinicians should prioritize supporting well-being and healthy lifestyles, preventive care, and cardiovascular risk reduction in these patients. Glycemic control efforts should individualize hemoglobin A(1c) targets so that those targets and the actions necessary to achieve them reflect patients' personal and clinical context and their informed values and preferences.”
Hospital-wide surveillance of catheter-related bloodstream infection: from the expected to the unexpected. (J Hosp Infect. 2009) “Catheter-related bloodstream infections (CRBSIs) are among the most frequent healthcare-associated infections and cause considerable morbidity, mortality, and resource use. CRBSI surveillance serves quality improvement, but is often restricted to intensive care units (ICUs).”
Marketing disease: is osteoporosis an example of 'disease mongering'? (Br J Nurs. 2009)
Most Mistakes in the Emergency Department Caused by Human Error
Two-Thirds Get Medical Tests with Radiation Dose
When Kids Are Hospitalized, Parents Fret About Errors “Parents can help prevent medical errors by being an active and informed member of their child's health-care team and by taking part in every decision about their child's health care, says the U.S. Agency for Healthcare Research and Quality.”
Why Do Doctors and Patients Not Follow Guidelines? “Summary: Guidelines are recommendations regarding clinical behaviour, and their implementation is a complex process that is influenced by different factors, related both to the characteristics of guidelines themselves and to the social, organizational, economic and political context or to implementation strategies. During the last few years, different studies and theories have tried to explain the reason why doctors and patients do not follow the guidelines. Following the guidelines most of all depends on the characteristics linked to the doctor's and patient's subjectivity, which can be a real obstacle. Knowledge, attitude, skills, experiences, believes and values play a fundamental role both in physician and patient. By addressing these issues to physician's and patient's adherence, more exhaustive approaches to guidelines development and spread can be applied in order to improve care and outcomes.”
X-ray equipment may be crawling with germs “Portable X-ray equipment is implicated in the spreading of drug-resistant bacteria in the intensive care unit (ICU), Israeli researchers report.”
2 in 3 had recent test with radiation, study says
Are We Aware How Contaminated our Mobile Phones with Nosocomial Pathogens? “Conclusion: These results showed that HCWs' hands and their mobile phones were contaminated with various types of microorganisms. Mobile phones used by HCWs in daily practice may be a source of nosocomial infections in hospitals.”
CT screening for coronary artery calcification can cause radiation-induced cancer “A study based on computer modeling of radiation risk suggests that widespread screening for the buildup of calcium in the arteries using computed tomography scans would lead to an estimated 42 additional radiation-induced cancer cases per 100,000 men and 62 cases per 100,000 women, according to a report in the July 13 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Coronary artery calcification is associated with coronary artery disease. "Computed tomography (CT) has been proposed as a tool for routine screening for coronary artery calcification in asymptomatic individuals as part of a comprehensive risk assessment," the authors write as background information in the article. Evidence suggests that this type of screening may detect the presence of calcium in the arteries of individuals who would be at low risk when assessed by traditional risk factors. "However, the potential risks of screening, including the risk of radiation-induced cancer, have to be considered along with the potential benefits."“
C. Difficile Easily Transmitted on Contaminated Work Surfaces “Results showed that in half of the cases, patients had as many contaminated spores on environmental surfaces in their rooms — the bed rail, the bedside table, the telephone, the call button — as they did on commonly touched skin surfaces, such as their chest, abdomen, and hands, said lead researcher Dubert Guerrero, MD, an infectious disease fellow at University Hospitals of Cleveland in Ohio. There was no significant difference in the number of spores that healthcare workers acquired on their hands after touching environmental surfaces and after having contact with patients, he added. "It's important to raise the awareness in healthcare workers that infection-control methods are important, especially wearing gloves and handwashing," Dr. Guerrero said. "Even if they don't touch patients, but just casually touch the handrail, they should practice strict infection control, because the environment is a significant source of transmission," he said.”
Doctors Reap Benefits By Doing Own Tests “A host of studies and reports by academics and the federal government shows that physicians who own scanners order many more scans than those who do not. As a result, Americans pay billions of dollars in extra taxes and insurance premiums. Government panels have found that, across several areas of medicine, ordering more procedures does not improve health outcomes. In the case of medical scans, unnecessary imaging also creates a health risk -- as many as 1 percent of all cancers in the United States appear to be caused by radiation from medical imaging, according to Amy Berrington de Gonzalez, a radiation epidemiologist at the National Cancer Institute.”
Experts Warn Over Health Check Brain Scans In UK
Is Lead Dust Within Nuclear Medicine Departments a Hazard to Pediatric Patients? (J Nucl Med Technol. 2009) “Because of the penetrating ability of the radiation used in nuclear medicine, metallic lead is widely used as radiation shielding. However, this shielding may present an insidious health hazard because of the dust that is readily removed from the surfaces of lead objects. The lead dust may become airborne, contaminate floors and other nearby surfaces, and be inadvertently inhaled or ingested by patients. We determined if the quantity of lead dust encountered within nuclear medicine departments exceeded Environmental Protection Agency (EPA) standards.”
MRSA: From Hospitals to Homes “Patients recently discharged from the hospital frequently carry methicillin-resistant Staphylococcus aureus (MRSA) with them from the hospital into their households. Although other household members may be colonized with the bacteria as a result, healthy household members do not appear likely to develop infections. MRSA is common in hospitals in most countries, and as the incidence of infection increases, new patterns of spread are emerging, according to the authors. "Thus, in the last decade, community-acquired MRSA strains have caused hospital outbreaks and sometimes replaced older strains previously responsible for hospital-acquired MRSA infections," the authors wrote. "Conversely, hospital-acquired MRSA strains can spread outside the health care system."”
Pfizer to pay record $2.3B penalty over promotions “The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer's salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages. Use of drugs for so-called "off-label" medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. They said the junkets and other company-paid perks were designed to promote Bextra and other drugs, to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness. Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke and death.”
Prostate Cancer Overdiagnosis in the United States: The Dimensions Revealed “More than 1 million additional men have been diagnosed with and treated for prostate cancer since the introduction of prostate-specific antigen (PSA) screening in the 1980s. And the "vast majority of these additional 1 million men did not benefit from early detection," write the authors of a new study published online August 31 in the Journal of the National Cancer Institute. "Prostate cancer screening has resulted in substantial overdiagnosis and in unnecessary treatment," Otis W. Brawley, MD, medical director of the American Cancer Society, writes in an editorial that accompanies the new study. These new findings once again question the benefits of prostate cancer screening, says Dr. Brawley.”
Screening for Prostate Cancer (CA Cancer J Clin 2009) “In the United States, prostate cancer will affect 1 man in 6 during his lifetime. Since the mid-1980s, screening with the prostate–specific antigen (PSA) blood test has more than doubled the risk of a prostate cancer diagnosis. A decrease in prostate cancer death rates has been observed since that time, but the relative contribution of PSA testing as opposed to other factors, such as improved treatment, has been uncertain. The recent release of 2 large randomized trials suggests that if there is a benefit of screening, it is, at best, small.”
Some cancer screening may do more harm than good “Nearly every body part susceptible to cancer has an advocacy group, politician or athlete with a public awareness campaign to promote routine screening tests -- even though it is well established that many of these exams offer little benefit for the general public. An upshot of the decades-long war on cancer is the popular belief that healthy people should regularly examine their bodies or undergo screening because early detection saves lives. But in fact, except for a few types of cancer, routine screening has not been proven to reduce the death toll from cancer for people without specific symptoms or risk factors -- like a breast lump or a family history of cancer -- and could even lead to harm, many experts on health say. That is why the continued rollout of screening campaigns, and even the introduction of a congressional bill, worries some health experts. And these experts say such efforts add to the large number of expensive and unnecessary treatments each year that help drive up the nation's health care bill. Rather than heed mass-market calls for screening, these experts urge people without symptoms or special risks to talk to their own doctors about what cancer tests, if any, might be appropriate for them. Blanket screenings do come with medical risks. A recent European study on prostate cancer screening indicated that saving one man's life from the disease would require screening about 1,400 men. But among those 1,400, 48 others would undergo treatments like surgery or radiation procedures that would not improve their health because the cancer was not life-threatening to begin with or because it was too far along. And those treatments could lead to complications including impotence, urinary incontinence and bowel problems. “
Survey Finds High Fees Common in Medical Care (USA) ““It’s the wild, wild West when it comes to prices of anything in the U.S. health care system, whether for a doctor visit or for hospital charges,” said Jonathan S. Skinner, a health economist at Dartmouth. The situation is so irrational, said Uwe E. Reinhardt, a health economist at Princeton, that it simply cannot go on. “We will not emerge out of this decade with this lunacy,” Dr. Reinhardt said, adding, “You worry about credit card charges, you scream for consumer protection — why not scream for it here?” … He put in three stitches, and Ms. Davis assumed her insurer, UnitedHealthcare, would cover the bill. It did not. The bill was $6,000 — $300 for the emergency room consultation and $5,700 for putting in the stitches. “
New Rankings of the Best US Hospitals “American Hospital Association Senior Vice President Rick Wade tells WebMD that hospitals that made the honor roll and those that were ranked in the 16 specialty groups were generally teaching hospitals "with the most cutting-edge research and technology." Wade says that hospitals that didn't score enough points to make a list should be avoided. "You can investigate on your own," he says. "For people who don't live near a Hopkins, there are many community hospitals that have very good records." Arthur Caplan, PhD, director of the Center for Bioethics at the University of Pennsylvania, tells WebMD that lists for most people "are almost useless. The only data of value is on specific doctors, treating cases analogous to your own." Rankings "are a quality perspective from 75,000 feet when what the prospective patient needs is precision at ground level about particular doctors doing particular things in situations close to the one the patient has," Caplan says.”
Report: Prostate cancer screening has yet to prove its worth “The recent release of two large randomized trials suggests that if there is a benefit of screening, it is, at best, small, says a new report in CA: A Cancer Journal for Clinicians. Authored by Otis W. Brawley, M.D. of the American Cancer Society and Donna Ankerst, Ph.D. and Ian M. Thompson, M.D. of the University of Texas Health Science Center at San Antonio, the review says because prostate cancer is virtually ubiquitous in men as they age, it is clear that a goal of "finding more cancers" is not acceptable. Instead, public health principles demand that screening must reduce the risk of death from prostate cancer, reduce the suffering from prostate cancer, or reduce health care costs when compared with a non-screening scenario. The authors suggest prostate cancer screening has yet to reach one of these standards to date. No major medical group, including the American Cancer Society, currently recommends routine prostate cancer screening for men at average risk. In the United States, prostate cancer will affect one man in six men during his lifetime. Since the mid-1980s, screening with the prostate–specific antigen (PSA) blood test has more than doubled the risk of a prostate cancer diagnosis. The review says a decrease in prostate cancer death rates has been observed since that time, but the relative contribution of PSA testing as opposed to other factors, such as improved treatment, has been uncertain.”
Researcher claims disease overtreated “It did not make sense to do something which would increase peoples risk "if you are offering something which has a considerable hazard, you have really added to their problems". The difficulty was that the commonly used prostate specific antigen test (PSA) led to over-diagnosis of cancers and over treatment. About 30% of men over 50 had a small tumour on their prostate which, when studied under a microscope was indistinguishable from cancer. A vast majority of these tumours did not appear to become a clinical disease or even cause symptoms. Research into randomised trials using PSA for screening showed that the over-diagnosis of cancers could be as high as 50%. Men were undergoing radical prostatectomy or radiotherapy which could result in chronic incontinence (urinary or faecal), impotence, or in some instances, death, he said. Dr Cox estimates that about 2000 cases of prostate cancer are detected by PSA testing a year in New Zealand and about half of them would never become clinically relevant. “
Numerous CT Scans Over Lifetime May Increase Cancer Risk “"CT is an excellent diagnostic tool of tremendous clinical value in many situations," Dr. Sodickson said. "Individual decisions about its use should balance the expected clinical benefits against the potential cumulative risks of recurrent imaging." Dr. Sodickson points out that for patients who have not undergone a large number of CT scans, the benefits of appropriate CT exams typically outweigh the potential risks. "However, we feel that a higher clinical threshold is warranted in patients undergoing a large amount of recurrent CT imaging," Dr. Sodickson said, "particularly if many of their prior CT scans have been negative. This scenario may result in a combination of high cumulative risk with low clinical benefit."“
One In Four Nursing Home Residents Carry MRSA, UK Study Suggests “Twenty-four per cent of residents and 7 per cent of staff were found to be colonised with MRSA, meaning they were carrying the bacteria but not necessarily showing signs of infection or illness.”
Overdiagnosis in publicly organised mammography screening programmes: systematic review of incidence trends “Screening for cancer may lead to earlier detection of lethal cancers but also detects harmless ones that will not cause death or symptoms. The detection of such cancers, which would not have been identified clinically in someone’s remaining lifetime, is called overdiagnosis and can only be harmful to those who experience it.1 As it is not possible to distinguish between lethal and harmless cancers, all detected cancers are treated. Overdiagnosis and overtreatment are therefore inevitable.2 It is well known that many cases of carcinoma in situ in the breast do not develop into potentially lethal invasive disease.1 In contrast, many find it difficult to accept that screening for breast cancer also leads to overdiagnosis of invasive cancer. Harmless invasive cancer is common, however, even for lung cancer, with 30% overdiagnosis after long term follow-up of patients screened by radiography.2 Autopsy studies have shown that invasive prostate cancer occurs in about 60% of men in their 60s, whereas the lifetime risk of dying from such cancer is only about 3%.2 Autopsy studies have also found inconsequential breast cancer lesions. Thirty seven per cent of women aged 40-54 who died from causes other than breast cancer had lesions of invasive or non-invasive cancer at autopsy, and half were visible on radiography.”
Patients Not Always Told of Lab Results “Casalino tells WebMD that "patients should never assume that no news is good news" because "a lot of things can go wrong in the office. Some may never receive a report from the lab, or it may come in but the doctor never sees it and it might get filed away before he does." He tells WebMD that many primary care doctors' offices are swamped with paperwork, making it easy for test reports to go to the wrong place, or the right place and not be seen, and that often procedures are not in place to make sure doctors see and act on lab results. "Doctors should at the least mail out a form and keep a copy in the charts," he says. "In our research team, it turned out that almost everybody had a personal experience with a missed communication." … But the backup for patients should always be to call their doctors if they aren't notified of the results of tests, Dunham says.“
PUBLICATION ETHICS AND THE GHOST MANAGEMENT OF MEDICAL PUBLICATION. (Bioethics. 2009)
Radiation dose from multidetector row CT imaging for acute stroke. (Neuroradiology. 2009)
Radiation Exposure Linked to Aggressive Thyroid Cancers “Thyroid cancer patients who've previously been exposed to radiation have more aggressive disease and worse outcomes than other patients, a new study finds. Researchers at Mount Sinai Hospital in Toronto studied 125 thyroid cancer patients who'd been exposed to radiation -- for example, in the workplace, through environmental exposure, or for treatment of acne or other benign conditions -- at least three years before they had surgery for their thyroid cancer. “
Ban Is Advised on 2 Top Pills for Pain Relief “The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.”
Cardiologist Gets 10 Years for Performing Unnecessary Interventions
Insured, but Bankrupted by Health Crises (USA) “Health insurance is supposed to offer protection — both medically and financially. But as it turns out, an estimated three-quarters of people who are pushed into personal bankruptcy by medical problems actually had insurance when they got sick or were injured.”
Medication errors: the importance of an accurate drug history (British Journal of Clinical Pharmacology 2009)
Medicine's Not-So-Silent Killer: Drugs Gone Bad “ "In the last dozen years, far more drugs that were approved have had to be withdrawn from their market than in the entire history of drug regulation in the United States," Jerome Hoffman, M.D., Professor of Medicine at the University of California, Los Angeles, told Ivanhoe. A recent study in JAMA says adverse drug reactions cause 100,000 deaths a year. Are drugs are being rushed to market? Are pharmaceutical companies promoting too much? Are patients demanding more than can be delivered? All of this is creating the perfect storm for disaster. “Their safety is uncertain because they’re newer, and they eventually turn out to be very unsafe," Dr. Hoffman said. … "If people were to know, for example, that one third of all trials for antidepressants show that the products are no more effective than a placebo, they might be a little bit less reluctant to take those drugs," Peter Lurie, M.D., Deputy Director of the Health Research Group at Public Citizen, told Ivanhoe. "I’m not saying they shouldn’t take them." In one year, $55 million were spent on advertising and promotion, almost twice as much as the industry spent on research and development. “They’ve got to get on the market as fast as possible, and while it’s on the market, they have to put the hard sell as much as possible," Dr. Lurie said. "If it turns out it’s for some use the product doesn’t even work, well, that doesn’t make any difference: A dollar is a dollar." “Overstating the benefits of the drugs, understating the risks, and the FDA is now letting them get away with it," Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen, told Ivanhoe. … Experts believe it will continue until doctors and patients demand honesty, integrity and transparency from the drug companies. Right now, money rules the making and marketing of medicine.”
Mobile phones may be source of hospital infections “Mobile phones used by hospital healthcare workers are often contaminated with germs, including those that can causes illness in hospitalized patients, a Turkish research team reports. Dr. Fatma Ulger and others at Ondokuz Mayis University, Samsun, swabbed the dominant hand and the mobile phones of 200 doctors, nurses, and other healthcare staff working in intensive care units and operating rooms. They found that 95 percent of telephones were contaminated, often with more than one type of microbe, and often with antibiotic-resistant bacteria. … They recommend routine decontamination of mobile phones with alcohol-containing disinfectants.”
Soap-sniffing Technology Encourages Hand Washing To Reduce Hospital-acquired Infections, Save Money
Surgical Errors Increase Deaths and Readmissions (Med Care. 2009)
Syncope and Its Consequences in Patients With Dementia Receiving Cholinesterase Inhibitors (Arch Intern Med. 2009) “Conclusions Use of cholinesterase inhibitors is associated with increased rates of syncope, bradycardia, pacemaker insertion, and hip fracture in older adults with dementia. The risk of these previously underrecognized serious adverse events must be weighed carefully against the drugs' generally modest benefits.”
Women who keep ovaries live longer “Each year, hundreds of thousands of women who undergo hysterectomies have their ovaries removed along with their uterus, a practice meant to protect them from ovarian cancer. But a new study has found that women who keep their ovaries live longer. While women who had their ovaries removed developed fewer breast cancers and almost entirely eliminated their risk of ovarian cancer over 24 years of follow-up, they were more likely to develop heart disease than women who kept their ovaries, and they were more likely to die. The new findings — from an analysis of data in the famous Nurses' Health Study, published in the May issue of the journal Obstetrics & Gynecology — raises questions about a widespread practice. Some 300,000 American women a year, about half of those who have hysterectomies, have their ovaries removed.“
World Health Organization Issues Guidelines on Hand Hygiene in Healthcare
YouTube videos weigh threat of CT radiation exposure “The IAEA video published online June 4 acknowledges diagnostic imaging's superlative contributions to medical science. However, it also warns that overutilization of high-tech procedures such as CT scanning may be unnecessarily exposing patients to increased doses of ionizing radiation. The agency's video compares the average CT scan dose with that of approximately 500 chest x-rays. It goes further by stating that such dosage could increase patients' lifetime risk of developing cancer, especially if they are repeatedly exposed to further exams. A brief interview with a practicing radiologist underscores concern among imagers about unprecedented growth in the volume of procedures involving increasingly younger patients. The agency's goal is not to scare people off about medical imaging but to cut down on unnecessary radiation exposure, said IAEA radiation safety specialist Dr. Madan Rehani. New studies suggest that radiation dose reductions of up to 50% could be achieved.”
Zicam Cold Remedy Nasal Products “FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.”
Getting evidence-based treatment “What is evidence-based treatment? In the last 15 years or so there's been more emphasis on testing the evidence behind biological logic or age-old assumptions handed down over the years, in a practice called evidence-based medicine. This is where biological assumptions are tested through randomised controlled trials (see below) to find out if the logic's fine, or the treatment is useless or, like the example above, dangerous. Once tested, the information is published in peer-reviewed scientific journals and used by government organisations such as the National Health and Medical Research Council (NHMRC) to make policies and guidelines for health professionals. The evidence, particularly behind drug treatments, has improved but there are still many types of treatments like surgery, physical therapies, natural therapies, dietary advice and counselling that haven't been properly tested. But even when there is evidence, you may not get treatment based on the latest evidence when you walk in your health professional's door – unless you ask for it. Asking for evidence-based treatment allows you to weigh up the benefits and risks of the treatment and talk to your health professional about your options. “
Handwashing More Important Than Isolation In Controlling MRSA Superbug Infection, Study Suggests “Regular handwashing by hospital staff and visitors did more to prevent the spread of the MRSA superbug than isolating infected patients.”
'Make hospitals admit error' call “The system for hospitals to report errors in the care of patients should be mandatory, a patients' group says. The Patients Association said that in the wake of the highly-critical report on Stafford Hospital, the time had come for the end to the voluntary system. The National Patient Safety Agency (NPSA) reporting system depends on NHS trusts owning up to mistakes. Regulators have already said the health service is not doing enough in reporting patient safety incidents. The NPSA has been collecting data since 2003 in a bid to help the heath service learn from its mistakes.”
Medical Errors Still Common in US Hospitals: HealthGrades Study “The investigators observed that, on average, Medicare patients treated at award-winning hospitals were 43% less likely to experience one of the assessed medical errors compared with those at bottom-ranking hospitals. "This finding of better performance was consistent across all 12 patient safety indicators studied," the authors write.”
Acid-Suppressive Medication Use and the Risk for Hospital-Acquired Pneumonia (JAMA 2009) “Conclusions In this large, hospital-based pharmacoepidemiologic cohort, acid-suppressive medication use was associated with 30% increased odds of hospital-acquired pneumonia. In subset analyses, statistically significant risk was demonstrated only for proton-pump inhibitor use.”
At V.A. Hospital, a Rogue Cancer Unit “Had the government responded more aggressively, it might have uncovered a rogue cancer unit at the hospital, one that operated with virtually no outside scrutiny and botched 92 of 116 cancer treatments over a span of more than six years — and then kept quiet about it, according to interviews with investigators, government officials and public records. The team continued implants for a year even though the equipment that measured whether patients received the proper radiation dose was broken. The radiation safety committee at the Veterans Affairs hospital knew of this problem but took no action, records show. … Peer review, a staple of every good hospital, in which colleagues examine one another’s work, did not exist in the unit. The V.A.’s radiation safety program; the Nuclear Regulatory Commission, which regulates the use of all nuclear materials; and the Joint Commission, a group that accredited the hospital, all failed to intervene; either their inspections had been limited or they had not acted decisively upon finding problems.”
'Best of the Best' Children's Hospitals
Deadly Medical Errors Still Plague U.S. “The new report is "right on," says Lucian Leape, MD, adjunct professor of health policy at Harvard School of Public Health and longtime patient safety advocate. The lack of progress in implementing the IOM recommendations, he says, ''is an immense public policy failure." "It's hard to argue with the fact that we're not where we need to be,'' agrees Diane Pinakiewicz, president of the National Patient Safety Foundation. Even so, some progress is evident, Leape tells WebMD. "There have been improvements on the hospital level with very little help from the government," he says. He is referring to the common hospital protocols to be sure the right patient is operated on, the right side or limb is operated on, and it's the right operation.”
Eli Lilly Accused of Pushing Ineffective Dementia Drug “In the early part of this decade, physicians — at the urging of drug maker Eli Lilly — prescribed Zyprexa for elderly patients with dementia. But the drug was not approved to treat dementia and was ineffective, and Lilly apparently knew that, some health insurers claim. Unsealed company documents reveal Lilly’s marketing campaign for the drug, originally approved for use as an anti-psychotic. The documents have been presented as evidence in litigation against Lilly for overpayment. … A company spokesman said the plaintiffs have released "one-sided, cherry-picked" documents that do not tell the whole story, and that Lilly will contest the charges in court. The released documents also allege that Eli Lilly produced a number of articles about Zyprexa, showing the drug in a positive light, and asked doctors to submit them to medical journals as their own work. The documents also allege that Lilly assembled a guide to selecting scientists who would write favorable articles. The documents saw the light of day only because of suits against the drug marker brought by health insurers and pension plans. These plaintiffs are seeking to recoup the money spent on Zyprexa to treat elderly policy holders with dementia. The plaintiffs also demand that Lilly pay $6.8 billion in damages for soft-peddling Zyprexa’s health risks and marketing it for unapproved uses.”
Ask Me If I've Washed My Hands “What shocked me most that day was observing this physician go from room to room, examining pregnant women, without washing his hands. It was only too ironic that the screen-savers on the computers where he entered his notes blinked insistently at him to wash his hands to protect patient health. Having spent only one afternoon there, I thought I must have missed it and convinced myself that I didn't have enough evidence to be sure. In my third year, however, I find I am having a similar experience, this time working with physicians in a clinic where they don't accept Medicaid, and most patients are Caucasian and well-insured. In the course of an afternoon, I followed my preceptor from room to room without seeing her touch either a faucet or a soap dispenser. She didn't change the ear tips on the otoscope, either. Just think of that waxy residue from the last patient making it into your ears, or worse, the combined earwax of every patient seen that day. Eww!”
FDA Scientists Complain to Obama of “Corruption” "The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead. … In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. "Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid." … In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies. Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA's in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval. Top FDA managers "committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along," the letter said.”
Get With the Guidelines-Stroke Linked to Improved Care for Stroke and TIA Patients “Adherence to evidence-based guidelines implemented through the Get With the Guidelines-Stroke (GWTG-Stroke) program resulted in significant improvements in hospital performance measures related to the care of stroke or transient-ischemic-attack (TIA) patients, including thrombolysis, smoking cessation, and early antithrombotics, the researchers report. Get With the Guidelines is a quality-improvement program first developed and implemented in coronary heart disease care. The program, a voluntary-participation project involving hospitals across the United States, has been adapted to improve adherence to guidelines in the area of stroke and TIA.”
Harvard Medical School in Ethics Quandary “In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects. Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments. “I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.” … But no one disputes that many individual Harvard Medical faculty members receive tens or even hundreds of thousands of dollars a year through industry consulting and speaking fees. Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care. The reports show 149 with financial ties to Pfizer and 130 with Merck.“
Serious Parenteral Medication Errors Common in Intensive Care Units
US Top Court Rules Against Wyeth in Liability Case “The U.S. Supreme Court ruled against the drugmaker Wyeth on Wednesday, holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by federal regulators. By a 6-to-3 vote in a major defeat for the pharmaceutical industry, the high court ruled that U.S. Food and Drug Administration labeling approvals do not pre-empt state laws and shield companies from damages as part of liability claims. … Stevens said Levine presented evidence of at least 20 incidents before her injury in which a Phenergan injection resulted in gangrene and an amputation. As the amputations mounted, Wyeth could have analyzed the accumulating data and added a stronger warning, he said. Stevens said the FDA traditionally has regarded state law as a complementary form of drug regulation.”
The Ponzi Scheme That Is Health Insurance “"Commercial, for-profit health insurance is one of the greatest Ponzi schemes ever foisted on the public," says a family medicine physician. "The executives are the ones that benefit to the detriment of everyone else. How else does the president of one of the largest insurance companies get to be a billionaire? By being at the top of the pyramid of companies' and individuals' premium payments." "The single most important factor in the atrociously high cost of healthcare in the United States is the rapacious, money-hungry insurance companies and their fat cat CEOs," comments an MPC contributor. "The damage that the insurance companies do is not limited to the salaries of the CEOs," says another contributor. "They waste the time and resources of healthcare workers, institutions, and patients. They are clearly a negative, wasteful element in healthcare today that needs to be heavily regulated, changed, or eliminated." Physicians point to a number of supposedly routine practices of the health insurance companies that cry out for oversight. One MPC participant remarks that health insurance companies increase their premiums even as they decrease coverage. Another discussant notes that insurers typically burden physicians and patients with filing requirements as part of a strategy to delay or deny legitimate claims. According to one contributor, some companies frequently change their coding schemas to avoid paying legitimate claims. "The insurance companies make billions of dollars in profit each year," says one MPC commentator, "and they do it by limiting care, denying claims, limiting contracts, and limiting reimbursements."“
Better NHS safety reporting call
Drugmakers' push boosts 'murky' ailment “Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently approved as treatments and drowning out unresolved questions — including whether it's a real disease at all. … Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments. Experts don't doubt the patients are in pain. They differ on what to call it and how to treat it. Many doctors and patients say the drugmakers are educating the medical establishment about a misunderstood illness, much as they did with depression in the 1980s. Those with fibromyalgia have often had to fight perceptions that they are hypochondriacs, or even faking their pain. … "The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials," said Wolfe, who directs the National Data Bank for Rheumatic Diseases in Wichita, Kan. Similar criticisms have dogged drugmakers' marketing of medicines for overactive bladder and restless legs syndrome. Many of the grants go to educational programs for doctors that feature seminars on the latest treatments and discoveries. … While Goldenberg continues to diagnose patients with fibromyalgia, some of his colleagues have stopped, saying the condition is a catchall covering a range of symptoms. Dr. Nortin Hadler says telling people they have fibromyalgia can actually doom them to a life of suffering by reinforcing the idea that they have an incurable disease. "It's been shown that if you are diagnosed with fibromyalgia, your chances for returning to a level of well-being that satisfies you are pretty dismal," said Hadler, a professor at the University of North Carolina, who has occasionally advised health insurers on how to deal with fibromyalgia. … "At the end of the day I don't care how you categorize this — it's a legitimate condition and these people are suffering," Clauw said.”
Failing hospital to review cases “In its report, the HC said "appalling" emergency care resulted in patients dying needlessly at the hospital, run by Mid Staffordshire NHS Foundation Trust. … It said that: • Unqualified receptionists carried out initial checks on patients arriving at the accident and emergency department • Heart monitors were turned off in the emergency assessment unit because nurses did not know how to use them • There were not enough nurses to provide proper care • The trust's management board did not routinely discuss the quality of care • Patients were "dumped" into a ward near A&E without nursing care so the four-hour A&E waiting time could be met • There was often no experienced surgeon in the hospital during the night“
Fake Internet Drugs Risk Lives And Fund Terrorism, Warns Journal Editor “"Harmful ingredients found in counterfeit medicines include arsenic, boric acid, leaded road paint, floor and shoe polish, talcum powder, chalk and brick dust and nickel" he points out. "In one scheme, Americans buying fake Viagra on the internet were actually helping to fund Middle East terrorism, unknowingly jeopardising the lives of men and women serving in their own armed forces." The UK's Medicines and Healthcare products Regulatory Agency estimates that nearly 62 per cent of the prescription only medicines offered on the internet, without the need for a prescription, are fakes.”
Healthcare-Associated Pneumonia Is More Severe Than Community-Acquired Pneumonia
HHS Action Plan to Prevent Healthcare-Associated Infections: Prevention – Prioritized Recommendations Among the recommendations: "• Leave catheters in place only as long as necessary. • Only trained personnel should insert catheters. • Use a cap, mask, sterile gown and gloves, and a large sterile drape for inserting central venous catheters. • Do not remove hair prior to surgery unless it will interfere with the operation. Then, use electric clippers. • Drain and discard condensate that collects in mechanical ventilator tubing.”
Hospital Diabetes Care Standards Not Met By US Academic Medical Centers
Hospital drug reactions 'common' “Joyce Robins, of Patient Concern, said the findings did not surprise her. "We get a lot of complaints from patients about the lack of checks and procedures regarding drugs in hospital. "Patients say they are not asked about allergies or what medication they are already on. They also say medication comes at all the wrong times. It is something that needs to be tackled."“
Mammograms may harm young BRCA mutation carriers “Due to the risk of radiation-induced breast cancer, mammographic screening in young BRCA mutation carriers may have a net harmful effect, according to a report in the Journal of the National Cancer Institute.”
Many Hospital Patients Can't ID Their Doctors “Most hospital patients cannot identify -- by name or role -- the doctors assigned to their care, a new case study of one urban hospital suggests. "The majority of hospitalized patients we looked at were not able to name anybody in charge of their care," said study author Dr. Vineet Arora, associate program director at the University of Chicago's internal medicine residency program. "And when they did name somebody, they got it wrong, incorrectly naming their primary care physician or some specialist. This reflects the fact that patients are seen by a lot of different doctors and teams, and they may simply not know who's in charge of their care." "Of course," Arora added, "it's hard to know how generalizable this is, as we only looked at one institution. But I suspect that the findings are probably reflective of the current situation at a lot of urban teaching hospitals."”
Overtreating Chronic Back Pain: Time to Back Off? (The Journal of the American Board of Family Medicine 2009)
Patients expect transparency in doctors’ relationships with the pharmaceutical industry (Med J Aust 2009) “Conclusions: Patients are currently not aware of their doctors’ competing interests but do want to know of doctors’ interactions with the pharmaceutical industry, indicating that disclosure of competing interests would improve their confidence in doctors’ decisions.”
Simple checklist cuts surgical deaths in half “Scrawl on the patient with a permanent marker to show where the surgeon should cut. Ask the person's name to make sure you have the right patient. Count sponges to make sure you didn't leave any inside the body. Doctors worldwide who followed a checklist of steps like these cut the death rate from surgery almost in half and complications by more than a third in a large international study of how to avoid blatant operating room mistakes.”
What Your Doctor Doesn't Know “However, the notion that your doctor knows the cause of your condition is often a medical myth. In fact, the amount of uncertainty present in most medical care is probably underestimated and underappreciated. The best health care providers recognize they are dealing with possibilities and probabilities and learn to accept uncertainty — certain fields of medicine have more uncertainty than others. … If you are one of the millions of back-pain sufferers, one doctor may diagnose "back strain." However, another doctor may tell you arthritis is causing your pain, while yet another diagnoses you with disk disease. They may all be exceptional physicians. But the scary thing is they may all be wrong. The fact is, most back pain cannot be definitively diagnosed. Despite all the fancy tests we could order, doctors are much better at telling people with back pain what they don't have (such as a fracture or tumor) than what they do have. … Perhaps the most important point to make here is that expectations of certainty from your health care professional may be unrealistic. If you have back pain, gout or shoulder pain and there's no clear answer about your condition, a second-opinion is a reasonable option to consider. But don't be surprised if the additional evaluation simply confirms the uncertainty of the situation.”
A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population (NEJM 2009) “Surgical complications are a considerable cause of death and disability around the world.3 They are devastating to patients, costly to health care systems, and often preventable, though their prevention typically requires a change in systems and individual behavior. In this study, a checklist-based program was associated with a significant decline in the rate of complications and death from surgery in a diverse group of institutions around the world. Applied on a global basis, this checklist program has the potential to prevent large numbers of deaths and disabling complications, although further study is needed to determine the precise mechanism and durability of the effect in specific settings.”
A survey of drug-dose calculation skills of Australian tertiary hospital doctors (Med J Aust 2009) “Medication errors are a source of significant morbidity and mortality among hospital patients worldwide. A United States study found that drug complications were the most common type of adverse hospital event, accounting for 19% of all these events.1 An adverse drug event is defined as any injury related to the use of a drug.2 The risk of a medication error causing an adverse drug event is increased by difficult and time-critical circumstances. A recent qualitative study highlighted a myriad of factors that may lead to a prescribing error — drug choice, route or dose, or drug omission.3 Each drug administration is a complex process, involving up to 40 individual steps.4 The risk of an adverse event is increased when the patient’s condition is unstable, or the drug is administered intravenously.1 Studies in the United Kingdom5,6 and the US7 have investigated hospital doctors’ ability to calculate and prescribe drug doses accurately, and the effect of education programs on this skill. Junior doctors were identified as being at particular risk of making medication errors and highlighted as a target for education.7,8 Studies have also tested calculation and prescribing skills of nurses9,10 and paramedics.11 A study of intensive care physicians found that most medication errors were in dosing, which is consistent with the finding that doctors have difficulty converting between ratios, mass concentration and percentages.5 To our knowledge, no similar research has been conducted in Australia. … This study showed that the doctors surveyed expected a higher level of skill in calculating drug doses from their colleagues than they achieved or expected of themselves. In addition, junior doctors and those in non-critical care specialties performed more poorly, clearly confirming the need for improved teaching of drug-dose calculations to medical students and junior staff.”
Add More Facts to Drug Ads, Experts Urge “People could make better decisions about which drug to choose if all ads carried a facts box clearly stating the medication's pros and cons, a new study suggests.”
CDC Study: Failures to Follow Infection Practices Have Placed More than 60,000 Patients at Risk for Hepatitis B and C “Patients were exposed to these potentially deadly diseases because health care personnel failed to follow basic infection control procedures and aseptic technique in injection safety. Reuse of syringes and blood-contamination of medications, equipment and devices were identified as common factors in these outbreaks. “More and more patients in the United States receive their health care in outpatient settings,” said Dr. Denise Cardo, director of CDC's Division of Healthcare Quality Promotion. “To protect patients, infection control training, professional oversight, licensing, innovative engineering controls and public awareness are needed in these health care settings.” … CDC officials say the report shows the need for ongoing professional education for health care providers, as well as consistent state oversight in detecting and preventing the transmission of bloodborne pathogens in health care settings.”
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