A leading member of the Senate said Wednesday that a prominent diabetes expert had leaked an unpublished and confidential medical journal article to GlaxoSmithKline last year, tipping the company to the imminent publication of safety questions involving the company’s diabetes drug Avandia.Click here to access the article.
Thursday, January 31, 2008
Monday, January 28, 2008
A new report from theClick here to read the press release.
offers a blueprint for a national program to assess the effectiveness of clinical services and to provide credible, unbiased information about what really works in health care. The report recommends that Congress direct the U.S. Department of Health and Human Services to establish a program with the authority, expertise, and resources necessary to set priorities for evaluating clinical services and to conduct systematic reviews of the evidence. This program would also be responsible for developing and promoting rigorous standards for clinical practice guidelines, which could help minimize the use of questionable services and target services to the patients most likely to benefit, said the committee that wrote the report. Instituteof Medicine
A technician mistakes an "a" for an "o" in a drug name. A doctor misplaces a decimal point in a prescription order. A nurse reaches for a vial in a cabinet as she's done hundreds of times before, only this time the light is dim and she fails to notice that the powder-blue label is more of a sky blue. The slip-ups are often simple, and always human, and all have happened in U.S. hospitals.Click here to access the article.
Each simple mistake is supposed to be countered by a recommended backup, a second or third set of eyes -- in other words, guidelines to reduce human error. A lot has to be overlooked in the cascade of errors that result in serious patient harm.
Saturday, January 26, 2008
Click here to read the entire article. Might CME Providers collaborate regionally and nationally on this topic? And what about Big Pharma -- would they fund such an effort?
The economic costs of diabetes in 2007 were estimated to be $58 billion, a figure that includes reduced productivity of both people in the labor force and unpaid workers, unemployment from diabetes-related disability, and increased absenteeism.
It's believed that about 6 million people in the United States have undiagnosed diabetes, which means the actual total cost of diabetes in 2007 may have been much more than $174 billion, the study said.
The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.
These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.
Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.
Click here to access.
Friday, January 25, 2008
Click here to access (sub. req.).
Merck & Co. and Schering-Plough Corp. defended their actions Friday involving a recently released study that raised questions about the effectiveness of cholesterol drugs Vytorin and Zetia.
The Food and Drug Adminstration, meanwhile, said it will review the partially completed study once it has been finished.The companies are being sued in several states over allegations they misled consumers into thinking the drugs were more effective than generics. In a statement Friday, the companies said they acted "with integrity and good faith."
British researchers found that women taking the pill for 15 years halved their chances of developing ovarian cancer and that the risk remained low more than 30 years later.
The findings were to be published Friday in The Lancet.
“Not only does the pill prevent pregnancy, but in the long term, you actually get less cancer as well,” said Valerie Beral, the study’s lead author and director of the Cancer Research UK Epidemiology Unit at Oxford University. The study was financed by Cancer Research UK, a charity, and Britain’s Medical Research Council.
Click here to access.
Thursday, January 24, 2008
After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.Click here to access the article.
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
Wednesday, January 23, 2008
Click here to access the NYT article; click here to access the OIG report.
Universities are increasingly seeking other sources of income to support research, and drug and device makers have become an important resource. But blending these sources of financing can often present researchers with troubling conflicts of interest, and managing such conflicts has become dizzyingly complex.
Indeed, academic medicine has become so rife with conflicts of interests in recent years that the Food and Drug Administration has complained that it has difficulty finding experts for its advisory boards who do not have a conflict.
Thursday, January 17, 2008
When Dr. Peter Pronovost assembled a checklist of proven safety procedures and required critical care doctors to use it, the results were indisputable: It prevented infections and saved lives.Click here to access the article (and to read the offending checklist).
But the veteran Johns Hopkins safety researcher also drew critical scrutiny from government regulators. In a decision last month that upset his colleagues nationwide, the federal Office of Human Research Protections said using a safety checklist - and studying its effects - amounted to conducting an experiment without a patient's consent.
The effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of favorable results, according to a review of unpublished data submitted to the Food and Drug Administration.Click here to read the article (sub. req.).
Since the overwhelming amount of published data on the drugs show they are effective, doctors unaware of the unpublished data are making inappropriate prescribing decisions that aren't in the best interest of their patients, according to researchers led by Erick Turner, a psychiatrist at Oregon Health & Science University. Sales of antidepressants total about $21 billion a year, according to IMS Health.
Tuesday, January 15, 2008
A new, highly drug-resistant strain of the “flesh-eating” MRSA bacteria is being spread among gay men in San Francisco and Boston, researchers reported on Monday.Click here to access the NYT article; click here to access the Annals of Internal Medicine article (sub. req.).
In a study published online by the journal Annals of Internal Medicine, the bacteria seemed to be spread most easily through anal intercourse but also through casual skin-to-skin contact and touching contaminated surfaces.
Monday, January 14, 2008
Click here to access.
Who is it for?This site is intended for those who plan and design programs for practicing clinicians, staff physicians, faculty members—and others interested in quality improvement, clinical outcomes, faculty development (especially related to CME teaching and planning), performance measurement and improvement, and for those engaged in health services and related research and related areas.
What is it about?Partly a portal, partly a resource, the site is regularly updated and is focused on moving CME from a purely conference-based model to one which employs best educational and quality principles to close the clinical care gap. It is linked to our colleagues in the GEA's sections on UME, GME, and RIME, elsewhere across the AAMC, and beyond. Mostly, this site is about you, and what you need for effective practice.
Sunday, January 13, 2008
Current accreditation mechanisms for CE are unnecessarily complex yet insufficiently rigorous. Compared to earlier, formal stages of health professions education, the CE enterprise is fragmented, poorly regulated, and uncoordinated; as a result, CE is highly variable in quality and poorly aligned with efforts to improve quality and enhance health outcomes.The report also includes some strong statements about commercial support of CME. Click here to access the report.
Thursday, January 10, 2008
Introduction:For questions, comments, endorsement privileges or copyright permission, please contact the authors: Melinda Steele (firstname.lastname@example.org) or Mark Schaffer (email@example.com). Click here to access the full paper.
Accredited providers of Continuing Medical Education activities have a responsibility to ensure that activities they certify for credit meet the Essentials and Standards of the Accreditation Council for Continuing Medical Education (ACCME). Compliance with the Standards for Commercial Support of Continuing Medical Education is an integral part of the process. One of the key factors related to the use of commercial support is the execution of a Letter of Agreement (LOA) between the Accredited Provider and the Commercial Interest (grantor) providing funding to support the activity. The purpose of the LOA is to document the independence of the Accredited Provider from any control of the commercial interest in the development and conduct of the educational activity.
Wednesday, January 09, 2008
The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.
The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.
Click here to access the FDA news release. (Someone in Malibu is probably furiously working that thighmaster).
We invite your participation in an important on-line survey for the World Health Organization's Collaborating Centre for Patient Safety. The survey seeks your help in determining the final content for the 2008 Patient Safety Solutions. Since the solutions will be distributed to all WHO member states, your assistance is needed to ready them for widespread adoption.Deadline for responses is Friday, February 29, 2008. Click here to access.
Monday, January 07, 2008
“It is absolutely the role of the oncologist” to provide a bit of emotional support, said Dr. James A. Tulsky, director of the Center for Palliative Care at Duke University Medical Center.
But in a study published last month in the Journal of Clinical Oncology, Dr. Tulsky and other researchers found that doctors and patients weren’t communicating all that well about emotions.
Click here to read the article.
FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates.Click here to read the entire alert.
Sunday, January 06, 2008
The Massachusetts subsidiary of an international surgical device manufacturer is under federal investigation for allegedly paying kickbacks to doctors to use its equipment, according to court documents and company disclosures.Click here to access the article.
Thursday, January 03, 2008
Methodological differences between the ways that IMS and CAM collect data will affect the values for promotional spending depending on the category being considered. Because of the problematic nature of some data from each firm, we believe that the most precise picture of industry spending can be obtained by selectively using both sets of figures.
CAM compiles its data on the value of detailing and samples through systematic surveys of primary care providers and specialists and by estimating an average cost for each visit by a sales representative according to the type of physician. By contrast, IMS compiles its data on the value of detailing through surveys of firms, while its data on samples are obtained by monitoring products directly from manufacturers.
Click here to read this article; interestin' stuff!
Fewer than one-third of all people who received samples in a 32,000-person, nationally representative survey had low incomes, and fewer than one-fifth who got the free drugs were uninsured at any point in 2003, the year analyzed by researchers at Cambridge Health Alliance and Harvard Medical School. Low income was defined as less than 200 percent of the federal poverty line.Click here to access. Study results will be published in the February issue of the American Journal of Public Health.
Free samples with a retail value of $16.4 billion were given out in 2004, the study says, up from $4.9 billion in 1996. Most were the newest, most expensive drugs, Cutrona said. Giving them away to patients is a way for pharmaceutical companies to introduce their new products to doctors and patients.
Wednesday, January 02, 2008
Patients today are less likely to bump into drug sales representatives at a doctor's office, as pharmaceutical companies adopt cheaper technologies and more discreet ways to pitch drugs.Click here to access the article.
The changes are partly in response to a backlash against overly aggressive marketing of the past decade, when many executives believed the company with the biggest sales force would have the highest sales. From 1999 to 2001, U.S. drug companies expanded their sales staffs, on average, by 42 percent, according to the most recent research available from Datamonitor.