Doctors in Germany Claim Major Breakthrough in Treating/Curing Child with Cerebral Palsy Using Stem Cells

The boy had been given injections of umbilical cord blood and his symptoms improved tremendously from being in a vegetable state.  Now he has been able to learn how to talk and to move.   The umbilical blood used was his own, stored from the time of his birth. 

The chances of survival were minimal but it appears this treatment of the child stands to be something worth more study in the fight against cerebral palsy and the boy is certainly much better off than he was at the start being totally brain dead after a heart attack.  His progress has been studied for 40 months.  BD

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Medics in Germany said they have successfully treated a child with cerebral palsy for the first time.

Just weeks after being given an intravenous stem cell treatment from umbilical cord blood, the symptoms of a boy who had been left in a vegetative state after a heart attack improved considerably and within months he could talk and move.

The doctors who carried out the treatment said the results of the treatment dispel "long-held doubts" surrounding the effectiveness of stem cell therapy.

They studied the progress of recovery at two, five, 12, 24, 30 and 40 months after his brain injury.

Jensen and his colleague Professor Eckard Hamelmann of the Department of Paediatrics at the Catholic Hospital Bochum, reported their success in the journal Case Reports in Transplantation.

http://www.heraldscotland.com/news/health/doctors-claim-cerebral-palsy-cure.21181174

Human Stem Cell Cloning Study Had Errors That Resulted From the “Rush” to Publish

The paper may have errors but the results are real said the professor as he personally made them himself.  He takes full responsibility for the mistakes made and there will be a new release coming forthwith fixing the mistakes.  BD

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A blockbuster study in which U.S. researchers reported that they had turned human skin cells into embryonic stem cells contained errors, its lead author has acknowledged.

Shoukhrat Mitalipov nevertheless adamantly stood by the conclusions of the study published last week in journal Cell, which reported that human stem cell lines for the first time had been created via cloning

Scientists said the research could one day offer new pathways in the fight against Parkinson's disease, multiple sclerosis, spinal cord injuries and blindness.

Since the reprogrammed cells use genetic material from the patient, there is no concern about transplant rejection.

Read more: http://www.nydailynews.com/life-style/health/author-stem-cell-cloning-study-admits-errors-article-1.1353645#ixzz2UKTHov9A

FDA Approves First HbA1c Test to Diagnose Diabetes

As the article states, current tests have been approved to only monitor  glucose levels and now with this approved test there’s a somewhat one stop test to do it.  A value of 6.5% will indicated the condition.  The text is manufactured by Roche.  BD

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The FDA has approved the first glycated hemoglobin (HbA1c) test to diagnose diabetes, the agency announced Thursday.

The Cobas Integra 800 Tina-quant HbA1cDx assay, made by Roche, will be the first such test that FDA will allow to be marketed as a diagnostic tool. HbA1c tests currently on the market have been approved only to monitor blood glucose control, not to diagnose diabetes.

http://www.medpagetoday.com/Endocrinology/Diabetes/39383

Healthcare Supply Chain Association Launches Website to List Medical Device Companies and Suppliers Who Pass Device Tax On To Hospitals–One Large Hospital EHR Software Vendor Included

I found this to be very interesting to be able to view the website and see the list.  Being I write about a lot of Health IT here and with the huge profits made by Cerner, it somewhat surprised me to see them on the list.  As we all know Cerner is one of the largest software suppliers of electronic medical records and has been around for a long time and has been noted in recent times with making record profits.  

Cerner has a page under their “store section” dedicated to the “Smart Room” which uses a lot of different software and hardware devices for an example and takes advantage of their CareAware technologies. 

In order for software to work, you need hardware so it may not be just a simple trail always going back to a manufacturer it seems? Below is the list as it shows today.  So how does this work and I think it could open up some new areas of discussion along the line here.  Does a hospital buying a bundled Health IT system that includes medical records know they are paying for the device tax and is it separately disclosed?  We know Cerner is not manufacturing all the devices they would sell to compliment the Health IT portion so is is individually by contract with the device company?  Also, this list is new and are other EHR companies doing the same?  The site also has an embedded copy of a letter from Stradis Healthcare whereby they announced their intention to impose the 2.3% device tax as a separate item on their invoices. 

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“The following medical device suppliers are shifting the burden of the medical device excise tax (MDET) directly to American hospitals and other healthcare providers:
Acuderm
AMX Solutions
Anatech Ltd
Avinger
Berkeley Advanced Biomaterials
Burlington Medical Supplies, Inc.
CIRS (Compuerized Imaging Reference Systems, Inc.)
Cardica
Cerner
DR Systems, Inc.
Electro-Cap International
Encompas, Unlimited
FHC
Fine Surgical Instruments, Inc.
Fujirebio
General Devices
Good Lite
Gynex
Hans Rudolph
Hobbs Medical Inc.
Hurricane Medical
I.C. Medical , Inc.
Implantech
International Medical Industries, Inc.
Luminex
Mastel
Medical Z
Misonix
Rhein Medical, Inc.
Sientra
Skeletal Dynamics, LLC
Spineview
STAAR Surgical
Stradis Healthcare
Technical Prospects, LLC
Tenacore
Thompson Surgical Instruments
Tosoh Bioscience, Inc.
Unipower
Waters Corp
Disclaimer: Please note that many companies have similar names. The list includes only the actual name of the companies which meet the described criteria. The fact that a vendor has a similar name does not mean that the vendor is or should be included on the list.”

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Again I will refer to my year long campaign that I sent off to the device lobbyists, companies and others about pursuing taxing and licensing data sellers to give an alternative route of revenue to help support Healthcare and being that it is an intangible huge amount of profiteering, not many could get their heads around it, while companies and banks put billions away in profits here, and a lot of it is healthcare data that is sold that does not fall under HIPAA.  It’s that old digital literacy issue again and not understanding or trying to make an effort to understand how all of this works and the IRS seemed to be too busy chasing the non profit GOP factions out there to pay much attention here.  This would make an excellent area to use excise taxing to help support Healthcare reform instead of continuing to pad the pockets of banks and companies, and some of them use data out of context against consumers, instead of all the time wasted in front of Congress just crying about cuts.  Even the NIH could not exercise themselves about that level either, so again we have a huge education war here on how  models and algorithms turn profits and how it ends up playing out in the real world.

Medical Device Companies Not Putting Up a Real Smart Battle to Reverse Device Taxes–Need to Offer Alternative Solutions for Missed Revenue, Taxing & Licensing Data Sellers Would Do It

In today’s world of automation and algorithmic formulas that make money, I think if you want to get rid of the tax, you should definitely bring another suggested solution to the table and nobody seems to be able to grasp this concept sadly.  In summary how will this tax all play out through out healthcare and what new laws will be proposed to circumvent some of this?  They will fail as we have not take any effort to establish who the data sellers are and what kind of data they sell and to who.  In the meantime, watch the nonsense here with more complexities added on who eventually pays the excise tax..a sad state of affairs here with trying to find a resolution with nobody bringing another plan to the table.  BD 

Cook Medical Cancels Plans for Factory Expansions–We Need Companies That Create Tangible Products As They Create Jobs–Tax The Data Sellers/Brokers Who Make Billions With Data Mining “Killer Algorithms” And Give the Device Companies a Break

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Although the Healthcare Supply Chain Association did not take a position on the medical device tax at the time — nor do we take a position today — the HSCA joined the American Hospital Association, the Federation of American Hospitals and the Catholic Health Association in urging the IRS not to allow medical device manufacturers to pass on the cost of the device tax to hospitals.

Unfortunately, the IRS did not respond directly to our comments at the time, and today maintains that it does not have the authority to police companies that pass on the device tax.
Hospitals are now reporting that, although some suppliers are behaving responsibly, other device manufacturers are billing hospitals directly to cover the costs associated with the medical device excise tax. Although there are more than 40 taxes found in the ACA, hospitals and other healthcare providers report that medical device suppliers are the only parties indicating that they plan to pass the tax on to their customers. That is not right.

http://thehill.com/blogs/congress-blog/healthcare/301887-some-medical-device-manufacturers-not-paying-their-share-of-health-reform#ixzz2UKA11VIp

Licensing and Excise Taxing Data Sellers, Facial Recognition Yet One More Tool Used To Secure & Match Data - The Epidemic, Billions in Profits for Banks and US Corporations Using Killer Algorithms to Further Erode Consumer Privacy

If you missed the recent report by 60 Minutes, this is very much worth watching.  Facial recognition technologies is growing quickly and getting more accurate all the time.  With using 3D modeling, matches are made to find the identity of individuals.  “Faceprint” is the new word to be aware of.  As pointed out the technologies need large data bases in order to work.  There is no regulation on companies using the technology.  The scientist who created the technology is even worried about the misuse by companies.  He feels he created a “monster” now as the technology moves forward. 

Big business is using it and cashing in as there are rules for government for non use by the US has no rules that pertain to companies.  I said a while back relative to privacy that privacy laws do not contain an avenue of IT infrastructure with rules lined out, it will fail and that’s exactly what we have here with all the feeble attempts to create consumers privacy laws with any kind of data, medical and otherwise and HIPAA offers little help sometimes and still remains in a silo at HHS.  Seniors are also big targets of the billion dollar profit data selling business.  This has been a long time campaign here at the Medical Quack and it was Chapter 17 of my series of posts called “The Attack of the Killer Algorithms” back in February of 2012 and when you add faceprints to the entire scenario, this means even more profits for companies who want to mine, query and resell your data.  It’s the same old story with regulators being behind the times with no clue on how to regulate as they don’t understand it and seem to make no efforts either.

Apple, Google and Facebook use faceprints and we know they all collect data so add faceprints to data and even richer information is available for query, matching and selling.  Companies are now working to find counter measures to avoid being “tagged”.  Watch the video where the software recognizes all your preferences and location and sends you a message using Facebook.  Will you trade your privacy for a diet coke?  What benefits are consumers getting, none but the profits grow for companies and banks.  When you read the link below you can see how health insurers are buying up data from banks relative to consumer purchases so how much data is here, we don’t know and does it include a “faceprint” as well? 

Insurance Companies Are Buying Up Consumer Spending Data-Time is Here to License and Tax the Data Sellers-As Insurers Sell Tons of Data, Gets Flawed Data When Data Buyers Uses Out of Context Too

This is also where data and information can be used out of context to profit as well and as I said a while back it’s a huge discriminatory practice against consumers as it will get tweaked for profit ad models are created that may not be accurate but rather make money with no concern for what happens to the end consumer.   Those talented in this area, Quants, are also concerned too as they do not want to be at the root of some of the items created that do attack consumers and have come up with their own codes of ethics as well as they too are in here as consumers and know how the data mechanics work, they are the talented ones that make billions for big corporations and banks.  See the tweet below on proprietary algorithms and it’s true as nobody is minding the store as we don’t seem to have enough talent in DC to understand how all of this is working.  The link below also has a number of big companies wondering what to do with big data as well and listen to how they speak out on trying to find “real” value.

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

Again when you watch the video you can see, depending on what data base is connected, even a social security number can be found on you.  Now you take this data and query it with other data bases and who knows what’s being sold.  Again with no mode of operation to identify who sells data and what kind of data to who, this is the absolute wild west here.  Facebook is mentioned many times as the data base of choice.  Even if you did not put your picture on Facebook, if someone else has, you may be up the privacy creek here.  Here’s a couple of my old posts back to 2009 relating on this subject…as without an arm of regulation spelling out IT infrastructure use, privacy laws are just pretty much useless and we can keep reading about the less than adequate bills that are proposed in DC.  So now when you combine faceprints with data profiles well how difficult is it to match data I ask…not that hard depending on the data available to query, use and sell. 

Does the US Government Need a Department of Modeling and Algorithms–Is Data Addiction and Abuse the Next Up and Coming 12 Step Program, Some Classic Posts & Topics Revisited

Your data is out there floating around the web and you have no clue how it got there and the errors in the data continue to rise as one bit of data containing errors gets aggregated all over the place.  It is an epidemic. 

Data Floating Around the Web and You Don’t Know How It Got There? Time to License and Excise Tax Data Sellers–Identify “Flawed Data” Epidemic At The Root of the Problem

“But she didn’t know which company had collected and shared the data in the first place, so she didn’t know how to have her entry removed from the original marketing list. “

Don’t hold your breath on our new consumer agency with Richard Cordray at the top as he’s building a data base to study and see how all this works, too bad we have someone who needs to learn all of this and we don’t have an expert who knows and understands the mechanics so I guess we have to pay for his education now too, a sad state of affairs when we have to spend more tax dollars to educate an attorney, and that doesn’t cut it today.  He has no clue and is way in over his head and this is why we need folks with some technology in their backgrounds as attorneys are good at research but they are not movers when they don’t have a tech background to combine with it.  I like our President and a lot of what he is doing but for the life of me I can’t understand why he keeps putting lawyers in positions to where they have no ability or education and expect them to produce results as most of them are digital illiterate when it comes to issues like this. 

Richard Cordray, Fail With Understanding Flawed Models and Algorithms -Big Case of“Algo Duping”With Big Data-Save Time, Hire Quants Who Know How Consumer Financial Models Are Built and Function…Geez

We are still allowing banks and companies to “model for inequality” and nobody is calling them to task.  Great video at the link below explains a lot of how this works from a quant who models, she tells is straight and worked for a Hedge Fund in the past, one who did work for Larry  Summers who has enough physics in his background to know how to manipulate I feel.  Cathy O’Neill states we need to stop lying with mathematical models, which is a lot of what is happening as lying models can and have made billions for many who use them.  She call some of this “Weapons of Math Destruction”…and she’s right. 

Modeling for Inequality With Segmentation, Insurance Industry Uses Backwards Segmentation As Some Models Stand to Threaten Overall Democracy

Here’s yet another great 60 Minute video to watch (Chapter 54 of the Killer Algorithm series) to see how all of this falls into place with the credit business and their models and algorithms…if you missed it, please watch and see how riddled with errors your credit information is and how it is modeled and used for profit and you don’t even get to see what is on record half the time as consumers are not given all the information.  Original post at link below. 

60 Minutes Confirms the Super Attacks of the Killer Algorithms With Consumer Credit Information With Flawed Data and the Inability to Algorithmically Fix Errors Which Really Makes a Huge Case for Licensing and Taxing All Data Sellers in the US–Chapter 54

This video and a few others worth watching are also on the “Algo Duping” page which is a collection of videos created by folks smarter than me, telling you the same thing.  Credit agencies of course cash in big time too with selling and reselling data and the flaws continue to roll and after all is said and done and the banks and companies make their billions, we as consumers are stuck on our own dime fixing the flawed data that they made billions selling for profit. 

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Again if the US government is every going to get serious about privacy they should update themselves with the times and start a system where we can identify and track who all the data sellers are, what they are selling and reselling and to who.  As I have mentioned on many occasions an excise tax on the billions in profits made could easily go to help fund the consumer agencies of the NIH and FDA, two of the most important government agencies we need.   

Time Has Come to License and Tax the Data Sellers of the Web, Companies, Banks, Social Networks..Any One Making a Profit-Latest Microsoft/Google Privacy War Helping the Cause –Consumers Deserve to Know What Is Being Sold and To Who in a Searchable Format

If you don’t see the addition of facial recognition as an even bigger source of profiteering, then you better think again as it makes re-matching data even easier for those profiting selling our data.  BD 

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Even if your picture isn't on the Internet, computerized facial recognition makes it virtually impossible to keep your "faceprint" private. Lesley Stahl reports.

http://www.cbsnews.com/video/watch/?id=50147158n

FDA Notifies mHealth Company They Want To Discuss The UChek App and Possibly Pursue Requesting a 510(k) Application for Approval

As mentioned the device and the $40 kit that goes along with the app sold on the App Store was featured at a TED Long Beach Convention earlier this year.  The FDA wants a chance to discuss and Biosense has stated they will work with the FDA and at the link below I thought it would be one that the FDA would question as well and here we have it. 

“This might be one of those apps if used in the US for the FDA to take a look at for a stamp of approval”

New Mobile App Does Urinalysis With the IPhone–Lab on a Phone

UChek works with test strips made by Siemens and Bayer which do not have approval to be used in an automated algorithmic process.  As I reported earlier the device is being tested at a hospital in India.  The app can be downloaded but needs the $40 device to work with it. 

 

 

 

 

 

 

Now that the FDA has stepped in it could be a while before the Android app is released.  As mentioned, this is the first letter of it’s kind sent from the FDA and it will be interesting to see if more are forthcoming as they do have their eyes open with watching what kind of mHealth apps are being developed and sold.  BD 

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An iPhone application that lets users check levels of blood, protein and other substances in their urine is the first target of U.S. regulators seeking boundaries in a burgeoning industry for medical diagnosis on-the-go.

UChek works with test strips made by Siemens AG (SIE) and Bayer AG (BAYN), which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.

The app needed to run the $40 automated system became available in Apple Inc. (AAPL)’s App Store earlier this year after being touted at the technology conference TED2013 at the end of February in California. The FDA told Biosense the company may need to gain agency clearance for the entire system, including the strips.  Depending on how a company responds, the FDA may follow up with a warning letter that sets out specific violations of the law that must be addressed immediately, Rivers said.

http://www.bloomberg.com/news/2013-05-23/iphone-urinalysis-draws-first-fda-inquiry-of-medical-apps.html

Cancer Drug to Treat Alzheimer’s Fails to Perform as Studies Can’t Replicate

Targretin was the drug that was used and as the article below states that based on the fact that it eliminated plaque behind Alzheimer's from the brains of mice, it did not work in the real world.  Trials were set up and some were able to get the prescription for the cancer drug, “off label” to treat Alzheimer’s.  This is actually sad that it didn’t work so there are still patients wanting the treatment, and again the studies were never replicated as was originally reported.  The drug, Targretin can also damage the liver so another side effect.  BD

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It sounded too good to be true and unfortunately it was.  Three research studies out Thursday severely diminish the hope that a cancer drug already on the market could be an Alzheimer’s treatment.

In February 2012 scientists at Case Western University Medical Center reported that a drug approved to treat skin cancer cured a mouse of a form of Alzheimer’s.  They reported the drug eliminated the plaque that is the hallmark of Alzheimer’s from the brains of the mice and that the mice seemed to recover from their memory and other cognitive problems.

Researchers quickly set up trials of the drug in people with Alzheimer’s. But some patients’ families did not want to wait for the human experiments.  They asked their doctors for prescriptions and in many cases, according to anecdotal reports, they got them.  "There is absolutely no reduction in amyloid levels in the brains of mice treated with this compound," Sisodia wrote in a technical comment in the journal Science. Teams at the University of Florida and researchers at the University of Leuven in Belgium published similar findings in the same journal.

http://vitals.nbcnews.com/_news/2013/05/23/18451554-alzheimers-drug-was-too-good-to-be-true-studies-find?lite?ocid=twitter