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Showing posts from November, 2013

morning-after pill less effective in overweight women

a disturbing story today that morning-after pills may not be as effective in overweight women (see  http://in.reuters.com/article/2013/11/26/us-fda-morningafter-idINBRE9AP02B20131126  for story). basically, European health regulators found that a French morning after pill marketed as Norlevo had decreasing effectiveness in women over 165 pounds and was not effective at all in those over 176 pounds, prompting the Europeans to order a label change.  turns out that Plan B in the US is basically the same composition. there was a comment in Physician's First Watch that  "According to the CDC, the average American woman weighs 166.2 pounds, which may raise concern about the efficacy of this type of emergency contraception among many U.S. women. The battle to make emergency contraception available has been long and arduous. Hopefully, this recent information will not discourage users, as this may still be the best option available."  a couple of comments: 1. i...

more drug company shenanigans: nonpublication of clinical trials

as part of the safeguard for clinical trials, the FDA modernization act mandated establishment of the Registry of Clinical Trials, with public access to information.  in 2007 the FDA Amendments Act expanded it to include prior studies, posting almost all trials at clinicaltrials.gov (by law: posting all prospective clinical study of health outcomes, studies involving drugs or other products regulated by the FDA, and controlled intervention studies in humans). Failure to comply with this mandate could result in penalties of up to $10,000 per day and withholding of funds from investigators sponsored by the NIH. In a recent studies reported in BMJ ( see   clinical trials negative results bmj 2013   in dropbox or doi: 10.1136/bmj.f6104) investigators looked at all trials with at least 500 participants in the clinical trials registry and completed prior to January 2009 and published by November 1, 2012. (These researchers focused on large studies because these would most ...

headache recs -- choosing wisely

headache recommendations -- choosing wisely G Geoff A. Modest, M.D.     Reply all | Sat 11/23/2013, 12:53 PM Geoff A. Modest, M.D. here is the latest of the choosing wisely suggestions (these are 5 suggestions by different specialties, with an eye to decrease unnecessary testing).  see  headache choosing wisely 2013  in dropbox, or go to URL  http://www.choosingwisely.org/wp-content/uploads/2013/11/AHS-5things-List_112013.pdf . 1. Don’t perform neuroimaging studies in patients with stable headaches  that meet criteria for migraine. (no increase in intracranial disease in pts with migraine) 2. Don’t perform computed tomography (CT) imaging for headache when  magnetic resonance imaging (MRI) is available, except in emergency settings (MRI more sens in picking up neoplasms, vasc dz, posterior fossa and cervicomedullary lesions, and high or low in...

chronic pain, yet again

in the flurry of recent articles on opioid prescribing for chronic pain, the annals of intl med came out with a systematic review and assessment of the 13 identified guidelines, evaluating them using 2 tools: AGREE II (appraisal of guidelines for research and evaluation II) and AMSTAR (a measurement tool to assess systematic reviews). for article,  see  chronic pain opioids annals 2013  in chronic pain folder in dropbox, or Nuckols, TK. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain -- online version 11/12/2013 annals of internal medicine for the articles. they basically found that the only 2 guidelines which received high ratings were the Am Pain Society one  ( chr pain guidelines am pain society jpain 2010   in chronic pain folder in dropbox, or  doi:10.1016/j.jpain.2008.10.008) and the Canadian National Opioid Use Guideline Group one. overall, they were quite impressed at the level of agreement in the diffe...

US health care system: too much focus on medical care

in oct  28 boston globe there was a review of a book "the health care paradox", by elizabeth  bradley  and lauren  taylor , public-health specialists -- see  http://www.bostonglobe.com/arts/books/2013/10/27/book-review-the-american-health-care-paradox-why-spending-more-getting-less-elizabeth-bradley-and-lauren-taylor/ynV1Sl5n0jZ1FUN817j4XN/story.html , which promotes a broader critique of the health care system. so,  i  must admit that in my past emails,  i  have railed against the US health care system, which spends more per person than any other (around  2x  as much as  next closest country) and has remarkably poor health outcomes (much worse than other industrialized countries and worse than several less-industrialized ones), and that has to do with the lack of a coordinated, coherent, accessible system of care, and unfettered profit-taking by drug companies, medical supply companies, hospitals, etc. And that the fix was...

new life expectancy table

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annals of intern med had article this week reviewing a 5% sample of medicare beneficiaries over 65 years old in different geographical areas and used claims data to assess comorbidities and subsequent survival, creating an updated and more extensive table (see  life expectancy table annals 2013  in dropbox, or  doi:10.7326/0003-4819-159-10-201311190-00005). people with hx of cancer were excluded.  the table is reproduced below. a couple of issues.      -- the sample reviewed may not reflect the entire elderly population, since it included fee-for-service medicare only.      --one intention of the study was to provide us guys with a way to assess when to stop health screening, perhaps limiting future mammograms or colonoscopy to those who have a reasonable 5 to 10-year survival.  one concern here is that there are no real screening data on people over 70-75 years old (studies not done), so we are left with mat...

EKG in athletes

this issue of NEJM has an article on role of cardiac screening pre-sports participation (see  athlete screening preparticipation nejm 2013  in dropbox, or DOI: 10.1056/NEJMclde1311642. article presents differing views on the appropriate extent of screening, esp whether to use EKG as part of the screen, noting that: --not common (around 100-150 young athletes die/yr in US), pales in comparison to numbers of youth who die from accidents, homicide, suicide, and even non-exercise assoc sudden death --still obviously a very tragic event when it happens, typically unsuspected in apparently totally healthy, vigorous person --everyone agrees to do pre-athletic screen with history/physical, best with standardized screen, assessing cardiac history of family and patient (eg   dizziness,  fainting, chest pain, shortness of breath and  palpitations during or after exercise, or a change  in exercise tolerance).  but family history only picks up 16% and ...

renal artery stenosis: stent not help

interventional therapy for renal artery stenosis (RAS) has been largely discredited, to my mind, since the publication of the ASTRAL study (NEJM 2009: 361:1953), which reported on 806 patients with atherosclerotic renovascular disease randomized to revascularization plus medical therapy or medical therapy alone and found that over 5 years the rate of progression of renal disease was no different, there was no difference in systolic blood pressure with minimal difference in diastolic blood pressure, but slightly more meds were used in the medication only group.  However of note, serious complications occurred in 23 patients in the revascularization group including 2 deaths and 3 amputations.  Conclusion was that substantial risks were associated with revascularization with no evident worthwhile clinical benefit. a study just reported at the American Heart Association, the CORAL trial, confirmed this earlier study (see  htn RAS stent vs med CORAL nejm  201...

dietary sodium and disease

 somewhat striking report by the Institute of Medicine on the health effects of limiting sodium consumption  (See  sodium and disease IOM report 2013  for the summary, or the 170 page full report as  sodium and disease IOM full report 2013  in dropbox).  Current guidelines are overall lowering sodium intake to 2300mg/d for those over 14yo,  with target of 1500 mg/d in higher risk people (African-Americans, those with diabetes/hypertension/chronic kidney dz, and those over 51 yo – ie, a majority of the population). The concern is that lowering sodium intake may not be entirely positive.  For example, low sodium intake is assoc with high plasma renin activity (PRA), which in some studies is assoc with increased CVD risk.  In one study of high risk pts with atherosclerosis or diabetes, PRA was independently assoc with hypertension, left ventricular hypertrophy, abnormal lipids, and insulin resistance.  The detailed review suggest...

Am heart assn guidelines for obesity and lifestyle

here are 2 of the other AHA guidelines released last week, obesity and lifestyle. less controversial than the other ones.... 1. obesity (see  obesity guidelines AHA  circ  2013  in dropbox or link:   http://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437739.71477.ee.citation  ) recommendations: in terms of assessing obesity, calculate BMI at least annually, using the current cutpoints of overweight as 25-30 and obesity greater than 30, noting that overweight identifies people at elevated risk of cardiovascular disease and obesity identifies those at elevated risk of mortality from all-causes.  These are grade B recommendations.  Another grade B recommendation was to measure waist circumference at annual visits, supported by expert opinion.  studies have found that waist circumference more accurately reflects visceral fat than BMI does, and visceral fat correlates with insulin resistance, lipid markers...

suboxone problems

--though milder and safer than other opioids (and counter to my initial training for suboxone prescribing), people can get high on subox, esp if relatively opiate-naive. --in terms of safety, since 2003 there have been 420 subox deaths in the US (vs 3625 methadone deaths, and lots more from oxycodone, etc as per my recent emails) --no surprisingly, some MD have been prescribing suboxone inappropriately (and many of them also have prescribed other opiates inappropriately) --(again different from my initial training), subox is sometimes being used by injection (the naloxone incorporated is supposed to create withdrawal when given IV and thereby make injecting the drug a strong deterrent. turns out that the level of naloxone may not be high enough, and some people who do get a naloxone reaction find it to be relatively mild and transient). not sure what the real data are here in terms of %'s, but per this article, it is being injected at times. so, my experie nce certainly ...

new AHA guidelines for risk assessment/statins

as has been hitting the papers, new guidelines for cholesterol management by am heart assn.  Sorry for this really, really, really long e-mail, but it is a lot shorter than the papers....   and, raises lots of questions 1. one guideline is on the assessment of cardiovascular risk (see  chol guideline cardiovasc risk assess circ 2013  in dropbox, or DOI: 10.1161/01.cir.0000437741.48606.98). this brief 50 page paper reviews the evidence for developing a new comprehensive 10 year risk assessment for ASCVD in non-Hispanic African American and non-Hispanic white men and women aged 40-79.  There is a link to a website to provide this calculat or  (see  http://my.americanheart.org/professional/StatementsGuidelines/PreventionGuidelines/Prevention-Guidelines_UCM_457698_SubHomePage.jsp ) This guideline also looked at:          -- the role of various other markers including hs-CRP, apoB, GFR, microalbumin...