31 Aralık 2012 Pazartesi

FDA Approves New Drug for Multi-Drug Resistant Tuberculosis, Sirturo –First New Drug in 40 Years for TB

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Amongst all the recalls Johnson and Johnson has had a good year with FDA approvals including this one as there has not bee anything new approved in years.  There is an inhaled TB vaccine in the works from a few years back.

Inhaled Tuberculosis Vaccine More Effective Than Traditional Shot


Probably more recent in the news was the “Occupy” location in Atlanta where homeless people were testing positive for TB.  The newimage drug is pretty hefty with warnings as well and is to be used after other medications have failed and carries the black box warning as it is considered a new class of drugs and there could be more deaths attributed to it’s use.    This type of TB is rare in the US but growing in other countries and TB is spread through the air.  BD

Atlanta Occupy Location Tests Positive for Tuberculosis and May Have to Relocate Again


The Food & Drug Administration today approved the first drug to treat multi-drug resistant tuberculosis, Johnson & Johnson’s (NYSE: JNJ) bedaquiline (Sirturo), an important breakthrough in the global fight against one of the world’s deadliest diseases.

Made by J&J’s Janssen Therapeutics division, based in Titusville, NJ, bedaquiline is meant for patients who have failed to respond to all other treatments.

It works by blocking an enzyme critical to the replication of M.tuberculosis bacteria, and the company said it is the first new drug in 40 years to attack TB via a new mechanism of action.

http://www.xconomy.com/new-york/2012/12/31/fda-approves-jj-drug-for-multi-drug-resistant-tuberculosis/

Cathy O’Neil, Mathematician/Quant: Wall Street Quants The Culture, Big Data Mechanics, Algorithms, Data Mining, Lack of Privacy, Web Profiling, Health Insurance Profiles and Modeling Abuse…

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imageThis is pretty good and I felt compelled to include this as she’s the one before the programmers, in other words, Quants build models and programmers design and build it.  In both videos you will find a lot of answers as she’s good and if you read here then you have probably heard a lot of this from a programming side.  She’s the first step ahead and created the model that programmers use to write software.  She has had  a very interesting background and she digs in to big data and that subject I think be renamed, the “data scientist”…same thoughts where in the world do you find these people.  You can find her blog here, MathBabe, like the name. 

“Data Scientists”– An Oxymoron? Is Finding the Value in Data Bases Queried Together in the Business World To Make Money Actually Science?


She gives her background about being a young nerd and she has been a professor and later was hired by a Wall Street Hedge Fund as a Quant.  She worked with Larry Summers who ended up going to work for the Obama Administration.  Her idea at the time was to “fix” the system.  Nobody including the SEC wanted to hire her and she says the same thing I have said many times, get the attorneys out and get the computer scientists folks in there.  She said nobody cared with the models and some of the CDO models were completely broken and gave random numbers.  Clients were never given fair warnings she said and she gave up and left and applied again to the Feds and and she signed forms to where she could not give away the private information on the models but she could talk about “techniques” of models and that’s what she does on her blog.  Her idea is to help people, not exploit them.  She says portfolios are “dummied” down into single numbers so those that think they understand can understand but they don’t really understand:)  My thoughts from a short while back on risk. 

Hiding, Falsifying, And Accelerating Risk Has Become the Achilles Heel of the US Economy As the “Real” World” Clashes With the Values Created From a World of “Fictional Values” Of Formulas and Math


Models are used increase obscurity and are not explained and are abused.  I made my comments on models used out of “context”.  imageAvoid doing harm she states.  She still models and knows the benefits when done correctly.  Nerds are never in charge.  I just talked with someone the other day where a study was done and the data was not supplied to substantiate the abstract and without the data, the recipient determined there were over 500 million available models, data counts and you just can’t take to the bank a report or study you see in the news without offering someone the opportunity to confirm the data origins, etc. 

Big Data/Analytics If Used Out of Context and Without True Values Stand To Be A Huge Discriminatory Practice Against Consumers–More Honest Data Scientists Needed to Formulate Accuracy/Value To Keep Algo Duping For Profit Out of the Game


A little later on she talks about how models get used “that was a really useful model to make a lot of money”…you’ve had heard something like that here before:)  People are trained to think of mathematics as a game you have to “win”, the culture in finance.  No Quants are ever expected to answer or account for the consequences on the effects of normal people.  Modeling has gone crazy and it has and it will. 

You can speed up to around 18 minutes where the healthcare portion comes in.  Think about 15 years from now she says, the information on the web about you never goes away.  De-Identified data, she says the same thing I said a few years ago, people are good at matching up De-Identified data, heck I did it years ago and not for the purpose of selling data or anything of the sort, it was some algorithms that I wrote for integrating software and to check and balance myself I created sample data that would rematch in the system for billing and an automated super bill system. 

Old hat been around a long time and a couple years ago the OMG stuff on the web about this being possible, that’s just when the public woke up. It’s not that we are really that smart it’s just that we have “been there done that” way before a consumer even hears the concept, why we are geeks:)  What is great about her videos is that she does for modeling about the same as I do for programming and there’s nothing like hands on as everyone else just reads other stuff and repeats it. She addresses both sides of healthcare data and says the clinical side is great and of course I agree, but then we have the health insurers who use segmentation in the opposite direction. 



She did some other jobs and a lot with credit risks.  Listen to her job offer about modeling in Hollywood and she’s see right through it with crazy modeling and how it keeps inequality alive.  If you want to hear her points on healthcare move forward to around 16 minutes.  Here’s a second video to where she talks at the Hadoop Strata Conference.  She says you can’t just rebrand people from the inside and turn them into data scientists. 

http://www.youtube.com/watch?v=3up4PezpthU



Here’s the series on the Attack of the Killer Algorithms that go right in line with what Cathy says and watch the videos and they are also on the left hand side of this blog on every page.  If you want a look into reality on how math and formulas rule the world, spend the time and get a tiny bit of education to understand how this works quietly behind the scenes and how the algorithms shift and take your money, a few SQL “strings” at a time.  BD


Attack of the Killer Algorithms–Digest & Links for All Chapters–on How Math and Crafty Formulas Today Running on Servers 24/7 Make Life Impacting Decisions About You

Quants: The Alchemists of Wall Street Video Documentary - Why It Needs to Matter What Companies Do and Not Focus Only On the Price of Stock With So Called Value - Attack of the Killer Algorithms Chapter 44


http://www.youtube.com/watch?v=hXdeRcvz_zE

Bill McDonough at Zeitgeist '07

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Bill McDonough at Zeitgeist '07 Tube. Duration : 20.22 Mins.

Session Title: The Green Collar Worker We're beginning to realize that all of us aren't just connected by the Internet; we're connected through the things we produce. McDonough, co-author of the seminal "Cradle to Cradle," has for years been a passionate advocate of green supply chains and living buildings. In this session, McDonough will discuss examples where companies have completely rethought their entire process of designing and delivering products to ensure they better mimic the natural world around them.
Keywords: Google, Zeitgeist

Almost Wasn't - A Memoir Of My Abortion And How God Used Me

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27 Aralık 2012 Perşembe

Inhaled Drug for Treating Schizophrenia and Bipolar Disorder Gets FDA Approval–Adasuve

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The drug is known as a rapid antipsychotic treatment and wasimage turned down back in 2010 as the FDA was concerned about the side effects, bronchial spasms.  This is interesting when you read this article as they were just about out of money if I an reading this correctly and were trying to find a buyer. 
From the website:

“All of our product candidates are based on our proprietary technology, the Staccato® system. The Staccato system vaporizes excipient-free drugs to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Because of the ideal particle size of the aerosol, the pure drug is quickly absorbed through the deep lung into the bloodstream, imageproviding speed of therapeutic onset that is comparable to intravenous (IV) administration but with greater ease, patient comfort and convenience.

Alexza's lead program is ADASUVE (Staccato loxapine or AZ-004), being developed for the acute treatment of agitation in patients with schizophrenia or bipolar disease, and has regulatory processes ongoing in both the United States and Europe”.

They also have other inhalable drugs in the pipeline to include migraine headache relief, insomnia and pain relief.  You can see at the link below another company has their spray inhalable system already FDA approved.  BD


Nasal Spray Drug Sprix Gets FDA Approval – Inhale and Sniff For Pain Relief


Alexza Pharmaceuticals Inc. (ALXA), the company that hired Lazard Ltd. (LAZ) a year ago to explore strategic options including selling itself, won U.S. approval of its rapid antipsychotic medicine.

The Food and Drug Administration cleared the inhaled treatment Adasuve for agitation associated with schizophrenia or bipolar disorder in adults, the company said today in a statement. The drug, recommended by European regulators for approval Dec. 14, will be the Mountain View, California-based company’s first product on the market.

The FDA also required Alexza to conduct a large post- marketing clinical trial of patients to assess “the real-world use” of the drug, the company said.

Alexza in February fired 29 employees, or 38 percent of its workforce, to focus on development of Adasuve and sold 44 million shares, raising about $20.4 million, the company said in a statement. The company had hired Lazard in December 2011 to explore whether it should find a buyer.

http://www.bloomberg.com/news/2012-12-21/alexza-wins-u-s-approval-for-inhaled-antipsychotic-drug.html

St. Johns Hospital Saga Continues As Options Are Weighed As Ownership and Future Discussions Take Place

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Los Angeles billionaire Patrick Soon-Shiong, a hospital imagesupporter who has committed $100 million to St. John's and  has his name on several buildings was shocked when the CEO and board recently were fired by the current Catholic out of state owners as it was in the works to sell the hospital.  Soon-Shiong said he would like to see the hospital back in the hands of local owners and he was also ready to help finance the sale.  St. John's is the only California hospital run by the Sisters of Charity in Denver.  The hospital was opened after World War 2 and has taken care of many celebrities in it’s time and has it’s Hollywood connections with philanthropy as well.  When Santa Monica Bay Physicians joined the UCLA Health System in 2010 St. Johns lost a bit of business. 

St. Johns Hospital Fires CEO And Several Board Members Fired By Email - Chan Soon-Shiong Puts Some of His Projects for the Hospital on Hold

The hospital would do well to affiliate with Cedars and UCLA but the new CEO from Sisters of Charity feels it should remain with a Catholic care system if it does not stay with the Sisters Group.  Nobody can understand why the relationship with the Sisters of Charity group has emerged the way it has as there has been a lot of money donated to the hospital over the years and some felt a bit dissed by the recent activities, which included Patrick Soon-Shiong who has put plans on hold for now with creating the genomic research and sports center at the hospital.  BD



Amid a nationwide wave of healthcare mergers, a deal was brewing this fall to sell St. John's Health Center, a storied Santa Monica hospital founded by Catholic nuns and befriended by Hollywood stars. 

Then, without notice, late last month the hospital's out-of-town owner ousted the top executives, fired most of the directors and thrust into public view a long-simmering debate about the hospital's future.

For months, officials at the hospital weighed various options including selling the hospital to rivals UCLA or Cedars-Sinai Medical Center or perhaps joining another Catholic hospital chain. Eventually, some board members supported the plan involving Soon-Shiong's foundation.

But the hospital's owner, the Sisters of Charity of Leavenworth Health System in Denver, stepped in before anything could be finalized. It removed the hospital's top two executives and escorted them off the premises the morning of Nov. 29. And it fired 15 of the hospital's 17 board members in a terse email.

In 1991, St. John's scored a coup by pulling the John Wayne Cancer Institute away from UCLA with the promise of top-notch facilities and support.

Three years later, in 1994, the Northridge earthquake shut St. John's for about nine months. But drawing on its connections to some of Southern California's wealthiest people, the hospital raised about $230 million to help rebuild. The years-long process was capped by the opening of its Keck Center building in 2010.

http://www.latimes.com/business/la-fi-saint-johns-shakeup-20121226,0,5475283,full.story

Christmas Day Tornado Damages Mobile Alabama Infirmary Hospital

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I don’t know if anyone was in the bed or not but this shook things up pretty well at the hospital it looks like.  There were quite a few homes damaged and so far no casualties yet listed.  Many were sitting down to Christmas dinner when the tornado hit.  No patients were harmed and the hospital is on generator power presently.  Many windows were knocked out and the hospital was also given news of yet another tornado watch.  BD 

imageThis is a photo sent to Reportit by FOX10 News viewer Michael Whitehead. He said this is second floor of Mobile Infirmary after a tornado struck Mobile on December 25.

image
This is a photo sent to Reportit by FOX10 News viewer Michael Whitehead. He said this is second floor of Mobile Infirmary after a tornado struck Mobile on December 25.

image


This is a photo sent to Reportit by FOX10 News viewer Michael Whitehead. He said this is second floor of Mobile Infirmary after a tornado struck Mobile on December 25.



http://interactives.fox10tv.com/photomojo/gallery/5565/112505/tornado-touches-down-christmas-day/mobile-infirmary-damaged-by-christmas-day-tornado/

Government Urges Software Companies to Find and Document Patient Harm Resulting From Electronic Medical Records–Checking Algorithms & Hey, Whatever Happened to the Common User Interface?

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When this question is posed, how can medical records cause patient harm?  First of all there is the user interface and every EHR/EMR has one as that’s how the information is viewed and entered, software 101. Now there’s nothing intentional here with vendors as hours, days, weeks and more are spent working with beta users to make it the best interface that can be developed and there maybe a few exceptions but most developers want their creations to be a success by all means, as otherwise nobody buys it. 

However, in the last couple of years the effort of user interfaces has become a little cloudy in the fact that more of the “payer” information have crept up with some priorities in some screens of the program and thus with the focus on money perhaps some of the user interface items may have slipped down a notch but they are still there. Money rules all today and something has to give when there are incentives along with doctors and hospitals not having enough operating funds in so many areas.  One item quoted here was the fact that one system had fonts that were too small, so again was that a problem for one or many individuals?  There’s no perfect system by all means as long as “humans” are using them. 

Speaking of a “good” user interface, there was this project from Microsoft a few years ago that was to incorporate and create a standard user interface that any medical record system could use, as it would make it easier for doctors who work at more than one hospital system to use instead of learning multiple user interfaces.  I had one med student email me a while back and he said he learned 5 systems to get through his residency and I am guessing he included PACS systems in there as well. 

EHRs need Standard Templates – So Let’s Look at the Common User Interface Project, a lot of the work is already in progress and partially completed


Ok so here’s the idea that was ahead of it’s time maybe?  Now we have many vendors looking over their user interfaces for fixes…what if all those vendors looked at one interface or at one that was pretty closely emulated by all?  Sounds like a lot easier job to me than looking at several hundred user interfaces.  Of course there’s a few other areas to look at with ensuring correct calculations and warnings but most of those are not very prominent by comparison. 



So, did we make an mistake in not giving a Common User Interface a little more attention with everyone building the “perfect” mouse trap?  This was all started back in 2008 and granted things became a bit more complex since that time but software grows on itself with additional layers added all the time, so maybe an idea that for whatever reason was sidelined?  I wrote this back in 2009 and being I wrote a simple EMR system years ago I kind of liked this idea as I looked at how much code and time is devoted to medical record system programming.  It’s a lot and look at the Allscripts case if you need more proof on the time it takes to write code today to make things work for the end users.  Granted the Silverlight portion could be updated to HTML5 to work in today’s world. 

Electronic Health Records Not Enough – Aggregation and Better Interfaces Needed



So in essence when it comes to innovation, we still don’t do very well with collaborating in some key areas it seems, right?  A few years ago I asked that question of several doctors if they would like the idea of having the same or very similar interface at every hospital, and nobody said no:) So now this is what we are left with, hundreds of EHR/EMR systems with different user interfaces to look at and track down the small fonts, data display for users, etc. anywhere that the software could make it difficult for humans.  I don’t’ know what this will end up netting in the long run but there’s no system that is 100% proof and again aside from looking at some of the payer priorities that may have entered to cloud some of this or making too much available on one screen with too many clicks..I’m not sure what this process is going to accomplish. 


A year ago GE found it had some errors as their system update created issues with attesting that they had to fix and this is just the world of software and is not patient related but goes to show issues will arise everywhere and to classify what is harm and what is not may be a little intense.  At this point I’m glad I’m not having to do this after the hours and part of a “life” that I put into programming and writing a system to find all of this or I would literally die at the keyboard:)  BD

GE Centricity EHRs Need To Fix Their Algorithms (Math)-Some Customers May Not Be Able to Attest Until The End of November After the Software Update


The Obama administration Friday urged cooperation between software companies and caregivers to prevent patient harm caused by faulty electronic records. But it stopped short of calling for regulation or a federal requirement to report computer mistakes that pose a risk to patients.

“We are saying to the vendors: Step up and prove your ability to create a code of conduct that would be enforceable, that would bind you voluntarily to reporting safety events,” Dr. Farzad Mostashari, the administration’s coordinator for health information technology, said about the report. “And what we’re saying is: If you don’t step up, we can always look at more classic regulatory approaches.”

http://www.govhealthit.com/news/mostashari-tells-ehr-makers-sort-out-safety-event-reporting

Metropolitan Chicago Healthcare Council Medical Record Exchange Could Collapse, Too Much Money to Develop and Participate For Many

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As always it comes back to money.  You can read the article and see where nobody denies the value but how do you get the value when the dollars are not there.  I think more and more areas of Health IT imagewill be asking the same question.  This is not to be confused with “insurance exchanges” in this instance as this is for sharing medical records only.  The group has gone to insurance companies to see if they will kick in some money.  I wouldn’t be one to hold my breath on that one but you never know, but grants seem to be more the way to get funded with medical health data if they can be had. 

Even with meaningful use incentives, some hospitals needs those dollars to stay open  in some hardship cases.  Big hospitals don’t want to pay 6 figure dollar amounts to participate as they have ton already invested in their own IT expenditures and those are growing too.  Even with non profit organizations that will in time benefit patient care, you still need money and can’t be priced out of the market as to what can be afforded it appears.  BD



Money is a sticking point, with some hospitals asked to pay six-figure annual fees to participate in the exchange. Big medical centers already have invested heavily in their own IT systems. They question the wisdom of plunking down more money on an electronic platform of uncertain value to them.
“No one really has a strong incentive to buy in and spend more than they're getting back without some long-term demonstrated value,” says Allan Friedman, research director at the Center for Technology Innovation at the Washington-based Brookings Institution, who has studied exchanges


The Metropolitan Chicago Healthcare Council, a nonprofit group of about 150 hospitals and healthcare providers, began organizing the Chicago-area exchange in 2009.


Despite initial interest, just 18 hospitals and physicians groups have agreed to join, says Dan Yunker, senior vice president of MCHC, which had planned to roll out the exchange a year ago. The start has been pushed back until mid-2013, he says.


http://www.modernhealthcare.com/article/20121223/INFO/312229943#ixzz2GHv72MPB