What the “Post-Antibiotic Age” Really Means

Posted on December 14, 2013 by gutsandgrowth

From the following site: When We Lose Antibiotics, Here’s Everything Else We’ll … – Wired

An excerpt:

If we really lost antibiotics to advancing drug resistance — and trust me, we’re not far off — here’s what we would lose. Not just the ability to treat infectious disease; that’s obvious.

But also: The ability to treat cancer, and to transplant organs, because doing those successfully relies on suppressing the immune system and willingly making ourselves vulnerable to infection. Any treatment that relies on a permanent port into the bloodstream — for instance, kidney dialysis. Any major open-cavity surgery, on the heart, the lungs, the abdomen. Any surgery on a part of the body that already harbors a population of bacteria: the guts, the bladder, the genitals. Implantable devices: new hips, new knees, new heart valves. Cosmetic plastic surgery. Liposuction. Tattoos.

We’d lose the ability to treat people after traumatic accidents, as major as crashing your car and as minor as your kid falling out of a tree. We’d lose the safety of modern childbirth: Before the antibiotic era, 5 women died out of every 1,000 who gave birth. One out of every nine skin infections killed. Three out of every 10 people who got pneumonia died from it.

And we’d lose, as well, a good portion of our cheap modern food supply. Most of the meat we eat in the industrialized world is raised with the routine use of antibiotics, to fatten livestock and protect them from the conditions in which the animals are raised.

Related posts:

GIKids Resource

Posted on December 13, 2013 by gutsandgrowth

For those of you who have not visited GIKids.org website:

GIKids – A Resource for Pediatric Digestive Disorders

It has literally A-Z handouts on pediatric GI problems for families, including four new handouts:

Clostridium difficile patient fact sheet: http://www.gikids.org/content/108/en/
Anorectal manometry patient fact sheet: http://www.gikids.org/content/109/en/Digestive%20Topics%20A-Z/Anorectal%20Manometry.html … …
Cow’s Milk Protein Intolerance patient fact sheet: http://www.gikids.org/content/103/en/
General nutrition and autism patient fact sheet: http://www.gikids.org/content/102/en/

Educated or Misinformed –Leading to Hemorrhagic Disease of the Newborn

Posted on December 12, 2013 by gutsandgrowth

“Hemorrhagic Disease of the Newborn,” now termed “Vitamin K Deficient Bleeding,” has reemerged as a problem. Many well-intentioned parents are refusing vitamin K to keep things more ‘natural’ for their infants. This phenomenon is likely encouraged by some alternative health websites and other parents; babies who are breastfed are at increased risk of vitamin K deficiency (without prophylaxis). Unfortunately, they are playing Russian roulette with their infant’s safety. In addition, many practitioners will not readily recognize this disorder because of the effectiveness of Vitamin K prophylaxis that has been provided since 1961.

An excerpt from the St. Louis Dispatch provides more information: Four babies hemorrhage after parents refuse vitamin K shot, a practice on the rise

Maternity care providers here and nationwide are on high alert for life-threatening vitamin K deficiencies in newborns, at the same time they are seeing more parents refusing a routine preventive injection.

The Centers for Disease Control and Prevention released a report last month about four babies in Nashville, Tenn., who hemorrhaged after their parents refused vitamin K injections at birth. The babies were diagnosed with life-threatening vitamin K deficiency bleeding between February and September. Three had bleeding in the brain, and one had gastrointestinal bleeding. They survived, but the infants with brain hemorrhages could have long-term neurological problems.

“Not giving vitamin K at birth is an emerging trend that can have devastating outcomes for infants and their families,” CDC director Dr. Tom Frieden stated in the report. “Ensuring that every newborn receives a vitamin K injection at birth is critical to protect infants.”

The vitamin is necessary for normal blood clotting, but because vitamin K does not transfer well across the placenta, most babies are born with low levels. The deficiency can lead to a rare, sudden bleeding disorder up to 6 months of age.

The CDC investigation found that parents refused the injection for several reasons, including a concern about an increased risk for cancer from the injection, an impression that it was unnecessary and a desire to minimize exposure to “toxins.” A 1992 study associated vitamin K and childhood leukemia, but the findings have been debunked by subsequent studies…

The number of parents refusing is more alarming at birth centers, which provide care led by midwives who support natural birth. Among the most recent 75 births at the Birth and Wellness Center in O’Fallon, Mo., 23 percent refused the injection, and 14 percent opted for the oral dose, said Jessica Henman, the center’s certified nurse midwife.

The CDC studied a random sample of births this year in the Nashville, Tenn., area and found that parents of 3.4 percent of 3,080 newborns discharged from hospitals had refused the vitamin K injection, while parents of 28 percent of 218 born at birth centers had refused…

A newborn not getting the injection is 81 times more likely to get the late form of the disorder than a baby who gets the shot, according to the CDC. [my emphasis in bold]

Bottomline: When seeing an infant with bleeding, ask about vitamin K prophylaxis after birth.

If a parent caused intracranial hemorrhage in an infant by shaking the infant, they would probably be jailed. What should be done in these cases?

Related blog post:

Bleeding due to vitamin K deficiency | gutsandgrowth

More Cents in Value-Added Care

Posted on December 11, 2013 by gutsandgrowth

While health policy experts of all political backgrounds agree that moving to a value-based (rather than volume-based) payment is worthwhile, there are many problems with this that were alluded to in the previous post. As an aside, I would like to see sports teams move to a value-based system so that I don’t have to hear that my team is paying its worst-performing players gobs of money.

Due to the potential pitfalls in transitioning to a value-based care system, an alternative strategy of working on the relative-value units (RVUs) has been advocated (NEJM 2013; 369: 2176-79). RVUs has provided a “uniform, formulaic metric for myriad clinical services” and serve as the method for setting fee-for-service payments for both Medicare and private insurance.

“Ideally, physicians’ work would be reimbursed on the basis of metrics that signal whether their clinical services efficiently improve patient outcomes and that use effective clinical risk adjustment. In reality, using patient outcomes as a basis for payment can work well at the health-system level, but small samples and inadequate risk adjustment limit their use for individual physicians and many group practices.”

Advantages of using an RVU-based system over other pay-for-performance benchmarks:

Long experience with RVUs (developed in 1988)
RVUs influence care delivery. “RVU distortions drove the development of …(ambulatory) procedural centers and the movement of cardiac imaging from physicians’ offices to hospital outpatient units.” This was “associated with a tripling of the proportion of cardiologists employed by hospitals.”
RVUs can be weighted towards activities that improve patient outcomes and high-value clinical services. Proposed examples: increased RVUs for smoking cessation counseling, and increased RVUs for stenting within 60 minutes for ST-segment elevation myocardial infarction
To start, “RVU levels for cognitive clinical work could be increased and those for procedural work could be decrease to create incentives for primary care services.”

Disadvantages of RVUs:

RVU levels are set by the American Medical Association’s Relative Value Update Committee; the process for setting RVUs is secretive and proprietary (though these can be modified by Medicare or other insurance companies)
RVU levels are not designed for team-based care

Bottomline: “Ultimately, refining this durable, well-entrenched system may be preferable to replacing it with unproven alternatives.”

Update -Last week I overestimated cost of sofusbuvir for hepatitis C (only $84,000 rather than $90,000), each pill is $1000, nyti.ms/1d6YxNk :

Gilead said the wholesale cost of Sovaldi, which is known generically as sofosbuvir, would be $28,000 for four weeks — or $1,000 per daily pill. That translates to $84,000 for the 12 weeks of treatment recommended for most patients, and $168,000 for the 24 weeks needed for a hard-to-treat strain of the virus.

Trying to make Cents out of Value Care

Posted on December 10, 2013 by gutsandgrowth

A series of commentaries helps outline the uncertain future with regard to ‘value-based care.’

NEJM 2013; 369: 2076-78
NEJM 2013; 369: 2079-81

Terminology:

Centers for Medicare and Medicaid Services (CMS)
Physician Value-Based Payment Modifier (PVBM)
Hospital Value-Based Purchasing (HVBP)
Affordable Care Act (ACA)
Physician Quality Reporting System (PQRS)

Background:

As part of the ACA’s attempt to bend the cost curve and improve quality simultaneously, PVBM seeks to financially reward physicians who provide high value cost-effective care to Medicare recipients. For physicians, the maximum bonus is 2%. Overall, the cost is neutral in the program as low-performing physicians are penalized. In 2015, this incentive will roll out for physicians in groups of 100 or more and for all physicians by January 1, 2017.

For hospitals, similar to PVBM there is HVBP. However, an important distinction is that hospitals have participated in the Hospital Inpatient Quality Reporting program for 9 years prior to the start of HVBP; over 90% of the roughly 3500 hospitals have participated in these quality measurements which serve as a lead-in to HVBP.

In contrast, less than 30% of eligible physicians actually report the analogous PQRS. Unlike hospitals, for physicians a difference of 1-2% in reimbursement is “small change.” The effort to report the data may be more costly than generating additional patient encounters.

What could go wrong?

“CMS cannot accurately measure any physician’s overall value, now or in the foreseeable future.” As a result, physicians do not respect the quality measures (PQRS) –for good reason. Some examples:

“Primary care physicians manage 400 different conditions in a year, and 70 conditions account for 80% of their patient load. Yet a primary care physician currently reports on as few as three PQRS measures.”
For radiologists, because there are not measures of diagnostic accuracy, PQRS measures exposure time to fluoroscopy.
For surgeons, because judgement of whether to do an operation and because the technical skill employed cannot be measured, PQRS measures adherence to antibiotic usage and anticoagulation prophylaxis. While these are important, they do not reflect a surgeon’s value.

Something New with FMT

Posted on December 9, 2013 by gutsandgrowth

“Resentment is like drinking poison and then hoping it will kill your enemies.” –Nelson Mandela

A brief review on Fecal Microbiota Transplantation (FMT) (Gastroenterol 2013; 145: 946-53) made a few points that I was not familiar with and reiterated many other important aspects.

With regard to preparation of FMT, early data suggests that using water rather than saline may result in better resolution of Clostridium difficile infection (CDI)
Adequate volumes of FMT material are needed, with rates as high as 97% CDI resolution with infusions >500 mL
While preliminary data suggested higher CDI resolution with colonoscopy infusion, a recent randomized controlled trial indicated that duodenal infusion was as effective as colonoscopic administration
Short-term data indicate very low adverse effect rates
While the only accepted role for FMT outside of clinical trials is for CDI, the review examined the potential benefit for inflammatory bowel disease (IBD), irritable bowel syndrome, chronic fatigue syndrome, and metabolic/cardiovascular disorders.
With IBD, there are currently 6 registered trials testing FMT for patients with IBD. Preliminary data have been more evident in small studies with ulcerative colitis.
The rationale for FMT in IBD is that IBD patients have reduced diversity and altered microbial flora. “However, it is not clear whether these differences are a cause or a consequence of the development of IBD.”

Related blog posts:

Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Did you see this? –Cost of multiple births

Posted on December 8, 2013 by gutsandgrowth

“A good head and a good heart are always a formidable combination.” –Nelson Mandela

A recent study from the American Journal of Obstetrics and Gynecology has found that “the adjusted total health care cost for singletons was around $21,000 per delivery, but the number for twins was $105,000 and over $400,000 for triplets or more.”

“The Centers for Disease Control and Prevention (CDC) shows that in 2010, 3% of all births in the US were multiple deliveries. The twin birth rate was 33.2 per 1,000 live births, and the triplet or higher birth rate was 1.4 per 1,000 live births.”

“The research was based on nearly 440,000 births among US women aged 19-45 from 2005 to 2010… The tally included all medical expenses for the mothers from 27 weeks before birth until 30 days afterward, combined with the medical costs of infant care for the first year.”

Links (with more information):

Buyer Beware: Online Pharmacy Problems

Posted on December 7, 2013 by gutsandgrowth

“It always seems impossible until it’s done.” –Nelson Mandela

From NY Times:

http://well.blogs.nytimes.com

Though technically illegal, millions of Americans buy prescription drugs from overseas pharmacies to save money. But the practice can be a huge gamble.

The National Association of Boards of Pharmacy, a professional group, reviewed over 10,000 Internet drug outlets and found that many sold fake or unapproved drugs. Some that claimed to be Canadian pharmacies actually sold medicines from developing countries where regulations are weak and counterfeit drugs are common.

Roger Bate, a pharmaceutical expert at the American Enterprise Institute, estimates that 2 to 3 percent of online pharmacies are legitimate. When buying Canadian, he said, look for outlets certified by the Canadian International Pharmacy Association, a trade group of Canadian pharmacies, or those certified by PharmacyChecker.com, a free website that verifies that the foreign sites it approves protect consumer information and meet quality standards.

Last year, Mr. Bate and his colleagues published a study analyzing 372 orders of five popular prescription drugs – Lipitor, Celebrex, Viagra, Nexium and Zoloft – that they purchased from 79 domestic and foreign online drug outlets. Products bought from Canadian or other foreign sites certified by C.I.P.A. or PharmacyChecker.com were of high quality. So were products ordered from American sites verified by either the N.A.B.P. or LegitScript.com, a certification agency founded by a former White House aide on drug policy issues.

But that was not the case for sites that were not certified by any of these four groups. Many of the drugs they sold were fakes, including about a quarter of the Viagra samples, which largely appeared to have originated in China.

“You can’t be 100 percent certain with any sites, frankly,” Mr. Bate said. “But you are running a much lower risk if you buy from a credentialed site.”

Fiber Intake and Crohn’s Disease

Posted on December 6, 2013 by gutsandgrowth

There are several lines of evidence that diet can contribute to the development and treatment of Crohn’s disease.

From a treatment standpoint, the most dramatic data has been with the effectiveness of enteral nutrition as a treatment option. In addition other environmental factors like being raised on a farm and use of antibiotics have been shown to alter the risk for Crohn’s disease; the former has been associated with a reduction in risk and the latter with an increased risk.

A new prospective study from 170,776 women followed over 26 years in the Nurses’ Health Study has identified up to a 40% reduction in the risk of Crohn’s disease among the highest fiber intake quintile (24 g/day) in comparison to the lowest intake quintile (12 g/day) (Gastroenterol 2013; 145: 970-77, editorial 925). Link to abstract: http://dx.doi.org/10.1053/j.gastro.2013.07.050 …

Specific findings:

Fruit intake was associated with greatest risk reduction. The median daily intake of fiber from fruit in the highest quintile was 6 g/day which is equivalent to 2 fruits (eg. banana or orange).
Vegetable intake was not associated with protection from Crohn’s disease.
The editorial notes that “reverse causation was addressed by evaluating cumulative exposure and including a 2-4 year lag period.”
However, the women in this study may not be representative and fiber intake could be an epiphenomenon. The women in the highest quintile were also less likely to smoke, use aspirin and have a body mass index <30 kg/m-squared.
Fiber intake did not significantly reduce the risk of ulcerative colitis

Bottomline: the “Institute of Medicine recommends that daily fiber consumption should be 14 g of fiber for every 1000 calories.” Thus, if one were to follow the guidelines by the IOM, all individuals would be consuming enough fiber to potentially reduce their risk of Crohn’s disease by 40%. Other fiber benefits include improve bowel habits, lowered cholesterol levels, weight loss, and lowered diabetes risk.

Reporting Bias: Infections with TNF Inhibitors

Posted on December 5, 2013 by gutsandgrowth

A recent article (Clin Infect Dis 2013; 57: 1318-30 -thanks to Jeff Lewis for this reference) summarized the pediatric literature on infectious complications associated with tumor necrosis factor-α (TNF) inhibitors for both Juvenile Idiopathic Arthritis (JIA) and Inflammatory Bowel Disease (IBD).

In total 33 studies for JIA were included and 39 studies for IBD. Many others were excluded due to overlapping cohorts or lack of sufficient data.

For JIA, the authors identified 296 infliximab (IFX) patients, 2465 etanercept patients, and 242 adalimumab patients. Most infectious were mild and mainly viral etiology. For example, 1016 upper respiratory illnesses with etanercept were reported. However there were a significant number of more serious infections which included lower respiratory infections (n=37), cellulitis/abscess (n=15), histoplasmosis (n=2), and meningitis (n=4). Four patients had infectious fatalities.

Similarly, for IBD, most patients had mild infections. Among 1407 IFX patients and 241 adalimumab (ADA) patients, there were 105 URIs noted. Again, more serious infectious were noted in many. Four fatalities were reported; 1 was due to disseminated CMV, 1 due to bacterial sepsis, and 2 were due to central line infections.

When examining this report, the question of reporting bias cannot be avoided. The various reports that were summarized included 30 prospective studies, 23 retrospective studies, and 19 various reports (case reports, case series, and FDA reports). The composite, in my view, likely overestimates the risk of serious infections. In addition, many of the infections may have been due to concurrent immunosuppressive therapy, but the details for this are lacking.

With regard to microbiology:

5 JIA patients had tuberculosis; there were no tuberculosis cases reported in the IBD cohort
Varicella/zoster was the most frequent viral infection and was frequently severe. In JIA cohort, there were 39 VZV cases (11 severe); among IBD cohort, there were 16 VZV cases (3 severe).

Bottomline: Given the frequent use of anti-TNF agents, better prospective pediatric data are needed. In addition, careful analysis of the data is needed for better attribution; the risk for many of these infections is likely due to concurrent medications like corticosteroids.

Also Noted:

Clin Gastroenterol Hepatol 2013; 11: 826-31. In a prospective cohort of 200 anti-TNF-naive adult patients (100 treated with IFX and 100 with ADA), the effectiveness was similar for IFX and ADA at both 1 and 2 year followup. Improved efficacy was noted when these agents were combined with immunomodulators, though this was statistically significant for IFX. The total patient response was 63.5% at 1 year and 45% at 2 years.