Jan 6, 2017

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The story

Like tight pants and soft work hours, biosimilars are a European trend ready to take the US by storm. We've got the latest on the spread of biosimilars to cancer. 

The basics

Unlike generic drugs, which are molecular mimics of brand name compounds, biosimilars aim for 'close enough'. Think Coke vs. Pepsi as two different ways to make cola, and you'll get the idea. The compounds are widely used in Europe, but only four biosimilar medications have received FDA approval in the US. And with the cost of biologic therapies on the rise – the drugs accounted for 62% of Medicare prescription spending in 2014 vs. just 32% in 2012 – the need for cheap alternatives is pressing. 

The target

Trastuzumab (Herceptin) is a monoclonal antibody against ERBB2 (formerly HER2 or HER2/neu). The antibody prolongs survival in early and late stage cancer in the 15 - 20% of breast cancers that are ERBB2-positive. The benefits come with a medication price tag of $60,000 per year, leaving many developing countries unable to foot the bill even though the World Health Organization lists trastuzumab as an essential medicine.

The trial

In a first foray of biosimilars into cancer biologic therapy, the Heritage Study evaluated 458 women with metastatic breast cancer and found that a trastuzumab biosimilar met all measures for equivalence to branded trastuzumab. Overall response rates to therapy, time to tumor progression, and rates of adverse events were similar between groups. All participants were from resource-poor settings, including developing countries in Europe, Asia, Africa, and South America.

The takeaway

Pricing is key for any trastuzumab biosimilar. If the study's sponsors, which include generic pharma companies recently under fire for rampant price inflation, can keep costs low, Heritage could give millions access to a vital cancer medicine.

Say it on rounds

When it's well after dark, and the fish from lunch is all that's left in the hospital cafeteria 

Bon appetit. A 730 patient RCT found that children of mothers who took daily fish oil supplements during pregnancy were 30% less likely to develop persistent wheeze or asthma. The children in the treatment group also had lower rates of respiratory infections at 5-year follow-up. The authors believe that long chain polyunsaturated fatty acids present in fish oil help diminish airway inflammation at the cellular level.

When you’re late for work and the roads are jammed

No one likes traffic, but a growing group of scientists worry that traffic-related air pollutants contribute to rising dementia rates. A 10-year cohort study of 6.5 million Ontario residents found an association between dementia and proximity to major roadways, with residents who lived within 50 feet of busy roads about 7% more likely to develop dementia than their peers. Dementia rates were higher for city-dwellers, which has your Manhattan-based writers – more forgetful with each remaining day of residency – a touch upset.

When you worry your clinic patients are tuning you out

Yelling probably won't help. A retrospective cohort of 300,000 patients at a Pennsylvania hospital found that patients with iron deficiency anemia were 2.5x more likely to develop hearing loss than their non-anemic counterparts. Since the cause of most hearing loss remains unknown, some are anxious to explore if and why anemia may play a role, though a lot more data is needed prior to drawing conclusions.
JAMA Otolaryngol Head Neck Surg

Brush up


The diagnosis of heart failure with preserved ejection fraction (HFpEF) is trickier than it's reduced ejection fraction cousin. Look for improvement in dyspnea in response to diuretics as a key clue in the clinical history. Send suspected patients for an echo (TTE), where Doppler evidence of impaired diastolic dysfunction is common but nonspecific. Elevated pulmonary pressures or natriuretic peptide levels can also aide in diagnosis, but disease criteria remain controversial and many feel that only a minority of cases are identified.

Get meta

With angiotensin antagonists and HFpEF. A pooled analysis of three major trials of ACE inhibitors and angiotensin receptor blockers (ARBs) found that angiotensin blockade did not improve HFpEF outcomes. The analysis follows a larger trend in which beta-blockers, spironolactone, and angiotensin antagonists – pillars of medical management in heart failure with reduced ejection fraction – have failed to prove efficacious in HFpEF.

The witching hour

It always feels like all of your patients get sick at once, but here's some proof: critical events on the same ward in a Chicago hospital (think ICU transfer, cardiac arrest, or rapid response team activation) were way more likely to occur in clusters

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