geoffrey modest medical blogs

And, an end-of-the-year blog… happy holidays to all. There was a timely article in STATnews (in particular their Pharmalot series by Ed Silverman which regularly exposes drug company malfeasance) about price-fixing among generic drug makers. And, 2 generic pharmaceutical executives have finally been accused by the feds (see https://www.statnews.com/pharmalot/2016/12/14/heritage-generics-antitrust-price-fixing/?s_campaign=trendmd ). Hopefully more to come... Jeffrey Glazer and Jason Malek of Heritage Pharmaceuticals, the former chief executive officer and president respectively, were accused by federal authorities of conspiring with rivals to fix prices for doxycycline hyclate and glyburide. This is the first criminal charges of a two-year federal investigation into such price-fixing among generic pharmaceuticals. At this point no other companies have been named, though Mylan Pharmaceuticals, Teva Pharmaceuticals, Actavis, Lannett Co, Impax Laboratories, Su...

The CDC just published their formal recommendations regarding HPV vaccination (see https://www.cdc.gov/mmwr/volumes/65/wr/mm6549a5.htm?s_cid=mm6549a5_x ): --give vaccine at age 11 or 12 (but can start as early as age 9, esp in cases of sexual abuse/assault). Males through age 21, females through age 26. MSM and transgender people should get vaccine through age 26 --2 shots if vaccine given before age 15, the second dose 6-12 months after the first; continue with the 3-dose series if start after age 15 (no change from old recommendations) --those with interrupted schedules (ie, longer than the recommended intervals) need not restart the vaccination series. The number of vaccine doses is based on the age of administration of the first dose. --those with immunocompromise (including HIV) should get the 3-dose series Commentary: --see prior blog  http://gmodestmedblogs.blogspot.com/2016/11/2-dose-hpv-vaccine-for-girls-and-boys.html  for details on the data supp...

There was another FDA warning recently, this time regarding systemic fluoroquinolones (ciprofloxacin, levofloxacin, etc), leading to a boxed warning, the FDA’s strongest warning (see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500665.htm for the summary, and  http://www.fda.gov/Drugs/DrugSafety/ucm511530.htm ​ for the full report).  Details: -- fluoroquinolones are associated with disabling and potentially permanent adverse effects on tendons (tendinitis, tendon rupture), muscles (muscle weakness or pain), joints (joint pain or swelling), peripheral nerves (peripheral neuropathy), and the central nervous system (anxiety, depression, hallucinations, suicidal thoughts, psychosis, confusion). Other adverse effects include worsening of myasthenia gravis, skin rash, sunburn (photosensitivity/phototoxicity), irregular heartbeat (including prolonged QT interval), severe diarrhea (they are the leading cause of Clostridium difficil...

There have been conflicting reports about piogitazone and bladder cancer over the years. T he FDA just came out with a specific updated review and warning (see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm for the brief statement and http://www.fda.gov/Drugs/DrugSafety/ucm519616.htm for the document). In 2010 the FDA commented that there was the potential for bladder cancer based on some human and animal studies, but they did not conclude there was an increased risk, the review was ongoing, and that patients should not stop taking pioglitazone. In 2011 they did require the manufacturer to include the bladder cancer warning. --the updated 2016 warning: --pioglitazone should not be given to those with active bladder cancer --clinicians should “carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer" --patients should contact their clinician if they ...

The National Institute on Drug Abuse at The National Institutes of Health just published their national survey results on adolescent drug use from 1975 to 2015, noting a remarkably significant decline on teen drug use, with the exception of marijuana (see http://www.monitoringthefuture.org/pubs/monographs/mtf-overview2015.pdf ). Key findings: -- For grades 8, 10, and 12 combined:                 -- any illicit drug use, annual prevalence: 20.2% in 1991, increasing to 31.8% in 2001 and ultimately decreasing to 26.8% in 2015                 -- any illicit drug use including inhalants, annual prevalence: 23.5% in 1991, increasing to 34.3% in 2001, then decreasing to 28.4% in 2015                 -- any illicit drug use other than marijuana, annual prev...

The National Institute on Drug Abuse at The National Institutes of Health just published their national survey results on adolescent drug use from 1975 to 2015, noting a remarkably significant decline on teen drug use, with the exception of marijuana (see http://www.monitoringthefuture.org/pubs/monographs/mtf-overview2015.pdf ). Key findings: -- For grades 8, 10, and 12 combined:                 -- any illicit drug use, annual prevalence: 20.2% in 1991, increasing to 31.8% in 2001 and ultimately decreasing to 26.8% in 2015                 -- any illicit drug use including inhalants, annual prevalence: 23.5% in 1991, increasing to 34.3% in 2001, then decreasing to 28.4% in 2015                 -- any illicit drug use other than marijuana, annual prev...

A recent guideline from the National Osteoporosis Foundation and the American Society for Preventive Cardiology, with support from an independent evidence review team from Tufts University, determined that calcium supplementation, with or without vitamin D, had no relationship to cardiac health (see  calcium and cad AIM2016 for the recommendations in dropbox, or doi:10.7326/M16-1743; or calcium and cad data review AIM2016 for the full document in dropbox or​ doi:10.7326/M16-116). Recommendations: --“ calcium with or without vitamin D intake from food or supplements has no relationship (beneficial or harmful) with the risk for cardiovascular and cerebrovascular disease, mortality, or all-cause mortality in generally healthy adults at this time ” -- calcium intake should not exceed the National Academy of Medicine recommendations of 2000-2500 mg/d -- obtaining calcium from food is preferred to taking supplements -- this recommendation is supported by a revie...

A recent study compared clinic blood pressure (CBP) measurements and ambulatory blood pressure monitoring (ABP), finding much more masked hypertension than white-coat hypertension (see  htn masked circ2016 in dropbox, or doi.org/10.1161/CIRCULATIONAHA.116.023404). White-coat hypertension is when the CBP is higher than the ABP; masked hypertension is the opposite. Details: -- 888 healthy, employed, middle-aged individuals not on antihypertensive medications, found in a workplace screening program to have a blood pressure of <160/105 mmHg, then had 24 hour ABP. -- Mean age 45, 89% female, 7.4% black/12% Hispanic -- They compared the awake ABP (aABP), the CBP, and the difference. CBP was an average of nine readings over three visits after being seated a minimum of five minutes, and the participants had not smoked, eaten or had caffeinated beverages in the prior 30 minutes. Two other blood pressures were recorded 1 to 2 minutes afterwards. T...

The CDC just released the  life   expectancy  statistics for the US from 2015, finding a decrease of 0.1 years from the 2014 numbers (see  http://www.cdc.gov/nchs/ products/databriefs/db267.htm   ). Details: --in 2015, there were 2,712,630 deaths, an increase in 86,212 --in 2015,  life   expectancy  was 78.8 years, with 0.1 year decrease from 2014    --for males, the decrease was 0.2 years from 76.5 to 76.3 in 2015    --for females, the decrease was 0.1 years from 81.3 to 81.2 in 2015    --for both, the change was only in  life   expectancy  from birth, with no change in the group who made it to 65 yo [ life   expectancy  for males aged 65 was 18.0 years, females 20.6 years: no change from 2014 to 2015. But no indication in their data as to why.  ??from more opiate deaths??] --the age-adjusted death rate increased 1.2% from 724.6 deaths/100,000 to 733.1 in 2015  ...

One increasingly common issue in primary care is what to say to patients who smoke only a few cigarettes a day. A recent observational study suggests that even smoking <1 cigarette per day as a consistent, long-term habit is associated with significantly increased mortality (see smoking small amt and mortality jamaintmed2016 in dropbox, or doi:10.1001/jamainternmed.2016.7511). Details: -- the National Institutes of Health – AARP Diet and Health Study is a huge database of 168,140 men and women aged 59 to 82 from 2004-2005 that has very specific information on cigarette smoking, including patient recall of their average number of cigarettes per day (CPD) during nine periods of time, starting with <15 yo to >70 yo (most of the time intervals were every 5 years until age 30 then every 10 years after that) along with number of CPD broken down into six categories (0, <1, then intervals of 10 CPD until 30, then >30 CPD)....

A recent meta-analysis/systematic review confirmed that a -blockers are efficacious in the treatment of patients with ureteral stones  (see  kidney stone alpha blockers review bmj2016 in dropbox , or  doi.org/10.1136/bmj.i6112 ). details: --55 unique RCTs, with 5990 randomized patients, mostly in European and Asian subjects. Mean stone size 5.7 mm, tamsulosin was the  a -blocker in 40 studies, mean follow-up of 28 days --primary outcome: proportion of patients who passed their stone --secondary outcomes: time to passage of stone, number of pain episodes, and proportion of patients who had surgery/were admitted to hospital/experienced adverse events results: -- a -blockers  facilitated the passage of stone, with risk ratio (RR)=1.49 (1.39-1.61), a 49% higher likelihood of stone passage (moderate quality  evidence)         --the pooled risk difference was 0.27, meaning that ...