geoffrey modest medical blogs

A couple of articles came out in the press showing that drug companies seem to have grovelled to a new low. 1. A STAT News investigation looked​ into required study reporting by major academic centers, finding pretty dramatic deficiencies http://www.statnews.com/2015/12/13/clinical-trials-investigation/  . details: --in 2004 the New York attorney general filed a lawsuit against GlaxoSmithKline for concealing data finding that Paxil (paroxetine) was associated with increased suicidal thoughts in teens, which led to federal  legislation to ensure that studies from drug and medical device makers report results through the NIH website ClinicalTrials.gov, or face a fine. the context here was that negative trials, or those finding significant adverse effects, might not be published, leading to clinicians using useless and perhaps harmful drugs or devices. these disclosures were to be reported on the website within one year of study completion or termination, or be subject to a fine

the CDC just came out with draft guidelines for prescribing opiates for chronic pain (see  http://www.regulations.gov/#!documentDetail;D=CDC-2015-0112-0002 ​ ). these draft recommendations include the following regarding when to initiate or continue prescribing opiates. 1. nonpharmacologic therapy and nonopioid meds are preferred for chronic pain. there are no data supporting chronic opiates, so hard to recommend given their known risks, except for this little caveat: "no study of opioid therapy versus placebo, no opioid therapy, or nonopioid therapy for chronic pain evaluated long-term (>1 year) outcomes related to pain, function, or quality of life. Most placebo-controlled randomized trials were <= 6 weeks in duration". so, no data really. there is a comment that it's okay for end-of-life care (commenting that "evidence of long-term opioid therapy for chronic pain outside of end-of-life care remains limited"), which does suggest there may be benefit

The vast majority of recommended HIV drug regimens include tenofovir (TDF)/emtricitabine (FTC) or abacavir (ABC)/lamivudine (3TC) as the nucleoside/tide reverse transcriptase inhibitor (NRTI) backbone.  From the 2015 HIV guidelines (see  http://blogs.bmj.com/ebm/2015/04/17/primary-care-corner-with-geoffrey-modest-md-updated-hiv-guidelines-2015/  for review)​, of the 5 initial recommended regimens, all have NRTI backbones: 4 include TDF/FTC and one has ABC/3TC. Similarly, of the 2 NNRTI-based (non-nucleoside reverse transcriptase inhibitor) and 4 PI-based (protease inhibitor) alternative regimen options, 5 have TDF/FTC and 1 has ABC/3TC as the backbone; and of the "other regimen options", 5 have either ABC/3TC or TDF/FTC. For those "who cannot have TDF or ABC", there is only one which is NRTI-free: darunavir/ritonavir (DRV/r) plus raltegravir (RAL), with the caveat not to use if the HIV viral load is >100K copies/ml. F or treatment-experienced patients, they reco

Ciproflox acin ​-resistant e. coli are increasingly found worldwide and are capable of causing extraintestinal infections, especially urinary tract infections. A report in 2006 found that 1.5% of healthy Seattle children excreted cipro-resistant e coli in their stool, without prior fluoroquinolone exposure. A new study looked at 80 healthy children  and their mothers ​ who were part of the St Louis twin cohort, assessing stool samples from 2010-2013 semiannually from mothers, and monthly from their twins til age 2 yo and then bimonthly, analyzing for e coli resistance  (see  microbiome gut colonization resistant  ecoli   jinfectdis2015  in  dropbox , or  J Infect Dis. (2015)  212  (12):  1862-1868). results: --15 kids (19%) and 8 mothers (20%) excreted ciprofloxacin-resistant e coli at least once, and 11 of 23 colonized subjects had multiple and usually consecutive positive samples --overall 33% of 40 families had at least 1 member with a positive culture for cipro-resistant e

a small study was just published as a research letter looking at the impact on  patient   satisfaction  when providers use computers in the exam room (see  computer use and pt  satisfaction  jamainternmed2015  in dropbox, or doi:10.1001/jamainternmed. 2015.6186.). this was an observational study done from Nov 2011 to Nov 2013 in an academic safety-net public hospital in San Francisco. details: --47  patients  (mean age 56.5, 55% women, 57% Hispanic/17% African-American/15% Asian/6% white, 55% primary Spanish speakers, 54% with high school education or less, 30% with inadequate health literacy as determined by their ability to fill out medical forms), and 39 clinicians (mean age 43.7, 64% women, 72% in primary care, 72% MDs, mean 13.9 years since getting professional degree) --provider- patient   relationship was <1 year in 16%, 1-5 years in 54% and >5 years in 30%. --mean visit length was 24.6 minutes --clinician computer use was low in 27% of encounters, moderate in 3

A recent study looked at the SGLT2 inhibitor (sodium-glucose cotransporter 2) empagliflozin and cardiovascular outcomes/mortality in patients with type 2 diabetes (see  dm empagliflozin cv outcomes nejm2015  in dropbox, or N Engl J Med 2015;373:2117​). The SGLTs are involved in active renal transport of glucose in the kidneys, and SGLT2 is the most important one (reabsorbs 90% of the glucose filtered by the glomeruli) and seems to be pretty kidney-specific (SGLT1 is less important in active glucose transport, getting the remaining 10%, and is more widely expressed and therefore more likely to have broader physiologic effects and adverse effects if blocked). the context of this study is that there are a slew of studies showing markedly increased cardiovascular (CV) mortality in patients with type 2 diabetes, this relationship seems to be dose-related, and the increase extends to those with pre-diabetes/glucose intolerance. Other studies have shown that empagliflozin is associated with

2 cohort studies (the  Framingham  Osteoarthritis Study, a local community-based study, and the Osteoarthritis Initiative, a multicenter longitudinal study, assessed the correlation between hip pain and  xray  findings for hip osteoarthritis, or OA (see  hip arthritis and  xrays   BMJ2015  in  dropbox , or  doi:10.1136 / bmj.h5983 ). details: -- Framingham  Study: 946 ambulatory individuals > 50yo  recruited in 2002-5. all had hip  xrays , and those with hip pain pointed to where they had hip pain on a visual hip representation, the frequency of the pain, and they were examined for pain with internal rotation. mean age 63.5, 56% women, 93% white, BMI 28, frequent hip pain in 13% though only 4% with pain in the groin or anterior thigh -- Osteoarthritis Initiative: 4366 ambulatory people who had or were at risk for knee OA. all had hip films and if they had pain, had the visual hip representation to localize the pain, questions about frequency of pain but no examination. mean a

A recent trial looked at the effect of on-demand short courses of TDF/FTC (tenofovir/emtricitabine) in preventing HIV transmission in men at high risk (see  hiv pre-exp prophylaxis IPERGAY NEJM2015  in dropbox, or N Engl J Med 2015;373:2237-46). T here was a prior blog on pre-exposure prophylaxis from the PROUD trial, with continuous use of TDF/FTC, and included a brief report on the I PERGAY trial prior to publication -- see  http://gmodestmedblogs.blogspot.com/2015/09/hiv-pre-exposure-prophylaxis.html   ​ . the full report on IPERGAY was just released, and i think it is so important that it is worth reviewing in some detail. --400 men without HIV infection but who had a history of at least 2 encounters of unprotected anal sex with men ​ within the past 6 months. those with hepatitis B or C were excluded, as well as those with eGFR <60ml/min, ALT > 2.5 times normal, and glycosuria or proteinuria >1+ on urine dipstick. --intervention: those randomized to active drug too