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Healthcare News of Note through 11/3/2012

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November 06, 2012 – Comments (0) | RELATED TICKERS: PFE , GE , MDT

Two weeks worth of my unusual blend of heavily hyperlinked healthcare news I found noteworthy.  Some last minute political stuff for those who need to read one more thing before voting today (I took care of that this morning).

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Healthcare News Week of 10/22/12

Wow.  Apparently the list of customers who bought the injectable steroid from NECC that has resulted in fungal meningitis deaths due to a contamination is some 1200 long.  This isn’t compounding for a patient or institution, this is manufacturing and should be registered (and inspected) as such with the FDA.

A lot of small molecule drug manufacturing has moved overseas in the past few years, though there have been recent signs of a return to the US in instances (flight to quality?).  One segment that has not seen this shift is biopharmaceutical manufacturing – until now.  CRO WuXi announced the opening of a GMP biopharmaceutical plant in China.

Speaking of China, GE and Medtronic continue to strategize on breaking into that market with their medical devices.  The focus appears to be on second tier cities now.  I believe China still has a ‘buy Chinese first’ policy regarding medical devices, which could be a barrier for some equipment, but also explains the M&A activity such as Medtronics purchase of China Kanghui Holdings. 

An editorial in the New England Journal of Medicine compares healthcare and baseball through the Moneyball lens.  The argument is that both are entrenched in their ways and hesitant to consider value oriented metrics for decision making.  Do ACO’s offer a path?   “The recent deployment of the accountable care organization model in health care delivery represents an important test of moneyball medicine in practice (2011a, 2011b). If such organizations can demonstrate the delivery of high-value care at lower costs, that would indeed hold promise for a moneyball revolution in medicine.”

IPO’s in the biotech space are always worth being informed on, though I’m only rarely inclined to invest there.  I do think novel technology and/or mechanisms can sometimes be worthwhile.  Fierce takes a look at the top 10 of 2012 (only 11), using emerging drug developers as a definition of IPO.   Of the group, Regulus may be the most novel.  With big pharma cutting programs the last few years, I’m surprised there aren’t more in-licensing companies like Tsaro or Durata looking to advance discarded assets.  Could Cempra become the next Cubist?

If IPAB isn’t an abbreviation you’ve heard before, expect to soon.  The Independent Payment Advisory Board (death panel?) has power to direct medicare payment actions outside of congress, and is seen as key to making the ‘affordable’ part of the affordable care act (ACA) work.  But, is it constitutional?  Even if its actions may be, it could be scuttled by the terms of its creation.

Election 2012  I know that many readers are here for political commentary … right?  And what is more important than the candidates’ positions on scientific matters (surely not the economy??).  Well, for those like me who enjoy the nuance over the sound bite, wherever it can be found, ScienceDebate.org has compiled the major candidates positions on topics like climate change, research funding, energy, food & water policies, etc. etc.  Worth a read for those on either side of their fences.

Track and Trace has long been considered by the regulators of the pharmaceutical industry, and may again be getting consideration.  The ability to trace every carton or bottle of a particular drug would diminish counterfeiting and  better enable recalls, but would come at a still significant added cost.  One day this will be a practical reality.

A healthday report comments that early clinical results, particularly those that have some wow factor early on, rarely replicate in later trials.  This comes as a surprise to … absolutely no one in the industry.  Anyone designing clinical trials appreciates that the early trials are smaller, and more selective in patient populations.  Demonstrating more widespread utility of a therapeutic and in often healthier populations, quite normally comes with a less impressive result than early work.

Fierce Health IT ran a feature article on the 8 most influential women in Health IT. More interesting to me than the women (I’m married after all) is where they are i.e. what are the centers and companies that will be influential in sculpting health IT. The featured women represent non-profits, regulatory agencies, hospital groups, public companies like Epic and AT&T, and start up firms. All have a role in shaping policy and providing IT products and services.

A study from Kaiser Permanente looked at palliative care coordination and found that patient satisfaction and cost savings could be realized with better coordinated care. This looks like a nice pilot for the broader medical home styled care coordination, so it is nice to see that benefits were realized.

Exercise. What isn’t it good for? I think it is a surprise to none that it makes for a sharper mind as well as healthier body. Go on, get some exercise today. Reading my blog isn’t enough to make one smart.

Biosimilars are expected to help bring down pharmaceutical costs, but not anywhere near to the degree of small molecule generics. How much savings and how much research would get physicians to switch to a biosimilar product is an open question. One survey indicates adoption will be challenging.

Here may be an interesting new app. Design your own genome. “The startup, called Genome Compiler, offers "a drag-and-drop genome construction tool, like computer aided design for genes," the Journal says, which would allow users to design synthetic genomes.“

Watson, the computer that won on Jeopardy, will be helping the Cleveland Clinic with training and the development of evidence based solutions to clinical issues.  And Watson will of course be learning from them as well.  I guess Wellpoint wasn’t keeping the computer busy enough.  Seriously though, better   

A study designed to inform medical students on the practices at different teaching hospitals found some significant variations in the care standards taught at the various institutions.

An oddish link was found that could help protect against heart attack and stroke.  It seems that having a flu shot was associated with the lowered likelihood.  Could this just signal individuals more concerned with their health, or is there a deeper correlation?  In any case, these kinds of associations will be more common as EHRs become the norm.

A couple of perspective pieces in the recent NEJM look at Medicare.  The first considers the insurance value of the program, which comes up short in the author’s opinion.  The second discusses the ‘Enduring Struggle’ to define reasonable and necessary care.  Both are thoughtful as these often are.

I often laugh at lists of stocks that are likely to benefit from one party or another gaining the presidency.  Often a short term lift due to expectations is all that materializes.  Nevertheless this kind of prognostication sells copy so … here is what Bloomberg has to say about the hospital stocks.

The Kaiser Family Foundation reports that Medicaid costs may be stabilizing and should be flat through 2013.  Costs rose less than the population on Medicaid did in the past year.  Cost controls in the form of payment cuts to providers appear to be the major reason.

Hurricane Sandy saw plenty of instances of patient evacuations and failed backup systems.  Worthy of review.

Hospitals are upset that MedPac is proposing flat payment reimbursement for certain procedures, whether they are in the hospital or office setting.  Yes, hospitals have the ability to offer more and broader services if needed, but that increases overhead and cost.  For many routine situations, this added cost burden is simply unnecessary.  Look for more health services to move out of hospital setting.

The steepest part of the pharma patent cliff may be behind us with Lipitor and Plavix gone generic, but expiring patents are a continuing reality for pharmaceutical companies and a big reason why more turn to biopharmaceuticals.  Here are some of the expirations expected in the next year.  Some of these are biopharmaceuticals where the revenue impact of patent loss is nowhere near what it is with small molecule drugs.

A NYU lab which created genetically tailored laboratory animals for specific research programs was destroyed by hurricane Sandy

More multimillion dollar legal settlements courtesy of the big pharma marketing machine.  Groan.  This one is from Pfizer for Rapamune.

The later stages of meaningful use for electronic medical records continues to evolve.  It looks like stage 3 may try to tackle the issue of pharmaceutical abuse.

Big science, social media, and crowdfunding may successfully interact in a study of the human gut microbial mix “A group of scientists based at several institutions in the US and beyond are getting set to kick off a crowdsourcing study called the "American Gut Project," aimed at assessing gut microbial communities in 10,000 or more individuals in the US in relation to their diet and lifestyle. … Participants in the project must be at least three months old and reside within the US, Leach noted. Those who sign up will be asked to donate $99 through a crowd-sourcing site called indiegogo.com. They will then be provided with a home sample collection kit. Once their samples are assessed, participants will be provided with a taxonomic profile of their gut microbiome.”  Interesting study and worth following to see how the paradigm works and whether other studies go this route.

Ralph

Helical Investor 

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