Mislabeling Work in Labs Sends Years of Cancer Research Down the Drain With Misidentified Contaminated Cells

Can you imagine being a scientist and then finding out later that the cells given for research were contaminated?  This is also hidden at times with researchers and journal publications have been in error as well and have had to be rescinded.  According to the article here there’s not much being done to ensure labeling is correct.  Researchers end up studying the wrong cancer cells and of course this directly impacts finding cures and treatments.

Some researchers have tried to bring this to light but are ignored by others they work with in fear that the errors, if brought forward would discredit an entire lab operation.  One doctor states that cell banks reported that 20% of cell lines for use in research are not properly identified and that’s a pretty large number.  When researching a specific tumor with misidentified cells, it becomes a waste of time, money an so on.

Cell lines are stored for years in freezers and the cells are what researchers study and are even shared  with other scientists so one mislabel can have a bit of a daisy chain effect.  One of the noted mix ups has been between breast cancer cells and melanoma and when it was further researched in one case the breast cancer cells were melanoma and not from a patient who had both. 

The cell lines uses are also published in journals so they can be identified for their point of origin.  One big concern is the financial end where many who donate and contribute money could possibly learn of such mistakes and the donation rates would drop.  With biotech financing being so tough to get, this is the last thing anyone would want to have hit with contaminated cell lines.  BD

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Cancer experts seeking to solve the problem have found that a fifth to a third or more of cancer cell lines tested were mistakenly identified—with researchers unwittingly studying the wrong cancers, slowing progress toward new treatments and wasting precious time and money.

In hundreds of documented cases that undermine a broad swath of research, cancer samples that were supposed to be one type of tumor have turned out to be another, through either careless laboratory handling, mislabeling or other mistakes.

It is a problem hiding in plain sight. Warnings to properly test cancer cell lines have sounded since the 1960s, a decade after scientists started making human cancer cell lines.

Much of cancer research seeks answers to questions of basic biology, so the proper identification of cell lines may be less important, said Dr. Masters. But when seeking cancer treatment for a specific tumor, he said, such mistakes "are an utter waste of public money, charity money and time."

These mix-ups are maddeningly difficult to pinpoint: an improperly sterilized pipette, a lab worker momentarily distracted, a misread label or a typo on a record sheet.

Cell repositories in the U.S., U.K., Germany and Japan have estimated that 18% to 36% of cancer cell lines are incorrectly identified. Researchers at Glasgow University and CellBank Australia found more than 360 such mistaken cell lines, including 100 that turned out to be the late Ms. Lack's cervical cancer cells.

Other scientists, following up on the observations at Stanford, demonstrated that MDA-MB-435 behaved like melanoma because it likely was melanoma—in particular, a skin-cancer cell line called M14.

Osamu Tetsu, a head-and-neck cancer researcher at the University of California, San Francisco, did a study in 2009 that concluded all six known cell lines used by researchers studying adenoid cystic carcinoma were contaminated.

All of the work done on the rare cancer—published papers, research, drug studies—had been conducted with mislabeled cell lines, Dr. Tetsu concluded. He called the findings "catastrophic."

http://online.wsj.com/article/SB10001424052970204571404577257513760102538.html

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Medical Marijuana Machine Gets Busted in Orange County–Battle Still Continues Over Access

 

 

The medical marijuana business still has issues over laws that don’t agree with one another.  In this case the city of Santa Ana closed down this dispensary and the machine too.  A couple years ago there was a machine installed in downtown Los Angeles that coincided with the “pot cards” that are now issued in California, also saying it was a safer way for patients to get their medications.  The machine also came with an “armed guard” and was only accessible during business hours.  In the news lately we have had law enforcement carrying out what laws I guess apply to their particular areas and the federal laws.  Banks are afraid to take the gamble in many areas. 

U.S. Medical Marijuana Business Having Issues With Banks–Is This Going to be a Cash Only Business?

In addition we had the raid in northern California on the school that teaches how to work with medical marijuana.

Medical Marijuana in the Picture Again As DEA Raids Oakland Oaksterdam University

In addition some coupons have tried to make it easier to help patients with getting access. 

Medical Marijuana Sellers Offering Online Coupons To Attract Patients

You can watch the vide below for the full story on what happened in Santa Ana.



Dispense Labs, a division of  the Dispensary Group, unveiled  Autospense  Friday, an automated dispensary that distributes medical marijuana and looks like a vending machine.

All that is needed to tap an Autospense machine is a registration card and unique PIN number, said Joe DeRobbio, Dispense Labs’ founder and CEO.

During after hours, Autospense is open only to patients who have agreed to the fingerprint option – they run their prints  through a scanner and swipe a registration card, DeRobbio said.

Autospense offers a secure, “businesslike” way to distribute and obtain medical marijuana,  said DeRobbio. With cameras, locks and sensors, the machines are difficult to break into.

Although Dispense Labs supplies the machines, it is not involved in growing the product, DeRobbio said.

“We are not associated with the industry,” he said. “We do not provide the medicine that goes in the machine.”

http://abcnews.go.com/blogs/headlines/2012/04/marijuana-vending-machine-by-calif-company/

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Microsoft Research–Where News Ideas Develop to Include Solving Big Problems Like the HIV Virus By Working With Email Spam Filters And Kinect

This is pretty wild that some of the same coding techniques that we use to identify spam mail can also be applied to identify HIV virus mutations and this is a great way to use “machine learning” for better research and knowledge.  Today there’s so much code written that you can in fact see what parts or portions of existing queries, etc. are built in and use those for another industry outside of the original design.  Mashable does some good coverage on this and also you have to love the video when you look at how they are working with augmented reality and the race car.

Of course there’s no better device and technology than Kinect that makes a lot of this happen.  In the video they are using the “Beamatron” technology as it is called to control a virtual race car that sees stuff in it’s path and having a virtual toy car as such might put some of the other folks out of business, maybe?  They also continue on to the demonstration of using Power Point in the same fashion.  We all know that Kinect is coming to Windows and developers are hard at work to make more of this happen. It is very interesting to see a million dollar surgical robot working with the $150 Kinect device, link below at what Johns Hopkins was working with. 

Kinect And daVinci Surgical Robot Do Simulated Surgery Suturing Together (Video)

If that isn’t enough you can see another use of Kinect with radiology taking the need to “touch” out of the picture.  Last year I attended the Israel Conference and had quite a bit of time to speak with Microsoft/XBOX Corporate VP Ilan Spillinger and of course he was also very high on medical solutions with Kinect. 

Microsoft Kinect Working with a PACS Server-Images on Steroids Via Gestures (Video)

When you watch the video with the car and passing the virtual “ball” around you get all kinds of ideas on how lighting, or other information could be shared like even in an operating room or the ER for that matter.  BD

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24 year Microsoft vet and Microsoft Research General Manager Kevin Schofield told me Microsoft Research is also focused, at least in part, on “solving big problems” like the HIV virus.

Medical Research would seem an odd fit for Microsoft, but the research group is filled with all kinds of experts, including a couple of MDs. One of them is also a computer scientist and became fascinated with how doctors make crucial decisions in high-pressure situations when they have incomplete information (think emergency room visits). This led to work in machine learning (Microsoft Research does a lot of work in this area), which uses what’s known to figure out the unknown. Spam filters work this way. They can look at email and if the word “Viagra” is in it, decide with some degree of certainty that it’s spam. Now, that research is being applied to HIV vaccine research.

The HIV virus is known for its tendency to mutate, which makes it hard for people to develop an immunity. A spam-like filter can find the known in the unknown — in this case the core, recognizable virus.

I asked Schofield, who began his carrier at Microsoft in the OS group, if Microsoft founder and former CEO Bill Gates used the legendary Bell Labs as a model for Microsoft Research. “At a 30,000 foot level,” Schofield said, “Bell Labs was the model, but on the ground it was more Carnegie Mellon.” There are, apparently, two styles of research lab: The Xerox Parc model, where you isolate research from the business and the other model, where you basically have business fund and drive research. Both approaches can hinder tech transfer. The second method, in particular, said Schofield, tends to guide research too strongly so that most of the work is spent delivering product enhancements. Schofield said Microsoft took the middle road.

Like any true research facility, Microsoft Research has its share of duds. I asked Schofield if there was a room where Microsoft Research keeps its failed experiments. “Failures would be a big room,” Schofield said, laughing. But he also counts some of those failures among Microsoft Research’s successes.

http://mashable.com/2012/04/21/microsoft-sexy-peek/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+mashable%2Ftech+%28Mashable+%C2%BB+Tech%29#59981Microsoft-Logo-on-Wall

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We Pay Gasoline Tax to Keep Up the US Highway Infrastructure–Why Not Tax the Data Selling Companies and Banks to Keep Up the US Government IT Infrastructure? A “Buffett Tax” Alternative

It’s time for another one of these posts since the Buffett Law on taxes is sinking or is sunk.  If you have followed any of the news in the last few years about the SEC (Madoff) and other government departments needing IT infrastructure updates, let’s face it, we need a tax for that. 

Corporations, Banks, High Frequency Traders, Social Networks, etc. all make Billions, that’s with a big “B” selling data they mine and most of the time get it for free.  States already license data miners but now their costs are going up as they have to install software to keep some of the “bots” out as they have tremendously grown in numbers and who pays for that?   Taxes are supposed to but they are all running short.  This was discussed before under Chapter 17 of “The Attack of the Killer Algorithms”.  They have teeth and make money and this is what you can’t see, touch or talk to running on servers 24/7 behind the scenes. 

Start Licensing and Taxing the Data Sellers of the Internet Making Billions of Profit Dollars Mining “Free Taxpayer Data”–Attack of the Killer Algorithms Chapter 17 - “Occupy Algorithms”– Help Stop Inequality in the US

I actually started out calling it the “Alternative Millionaires Tax a while back.  Not too long ago I saw somewhere that Google was offering a “tiny” bit of money for those to agree to let them use their data.  I can’t remember where but it was out there. 

The Alternative Millionaire’s Tax–License and Tax Big Corporations Who Mine and Sell Taxpayer Data They Get for Free From the Internet-Phase One to Restore Middle Class With Transparency, Disclosure and Money

CoreLogic, one of the data miners for credit information  has formed a partnership with FICO who is already in the process of selling algorithms with mismatched data which connects public information about you and combines it with your credit score to tell if you as a medical patient will take your prescriptions.  Somebody needs to start calling some of these folks on “mis matched data” that discriminates as now we have “Discrimination by the Algorithm” and it’s showing in more places all the time.   Others actually say it a lot better than I do, video below.

You Are the Product–Privacy Anonymity and Net Neutrality On the Internet - Excellent Stanford University Lecture (Video)

So the next time you are out there buying that tire to keep your car rolling, and pay a federal excise tax, give this some thought on the millions and billions being made by corporate US today from the “free taxpayer data” they mind and scrape for free and all the money they make off the backs of taxpayers, and this should be a way of corporations giving some of it back and would add some real transparency as we don’t know what all they are selling and to who? 

Walgreens said in their 2010 SEC statement that they made short of $800 million, just from selling data, so one has to wonder if filling prescriptions is a side business to collect that data and how much profit would they show without this source of income?  It’s large enough to be taxed and for them to have a license to mine and sell data.  So far I have not had anyone “not” like this idea and separate it from Income Tax and require quarterly payments and an updated license every quarter so we know all are compliant.  Here’s a little hindsight or foresight, a post I made back in August of 2009 and we need this now with the amount of “flawed data” and software out there. 

“Department of Algorithms – Do We Need One of These to Regulate Upcoming Laws?

As consumers we have become data chasers to fix everything that has been put in data files that for the most part we had nothing to do with, unless you give it all away on Facebook and other social networks. 

Attack of the Killer Algorithms Part 6–Discrimination With Consumer Credit-Same As Health Insurance Wanting Consumers to Reconstruct Records From Many Years Past As Middle Class Turns Into Data Chasers-Days of Taking Risks to Get Ahead Will Be Limited For Most…Occupy Algorithms

So again, where’s the tax in the US to keep up the IT Infrastructure, I don’t think there is one and we certainly could use it as big business runs over government all day long and we as consumers suffer with the Attacks of the Killer Algorithms as there’s no system and balance to protect us as the government is outdone over and over in most areas, with the exception of the military for the most part. 

When folks get out of the military we hear one story after another though too and how they are not getting their proper benefits either and join the rank and file of the rest of us not protected by an adequate IT Infrastructure.  The SEC and the FDA come to mind as 2 departments that could really use the support with IT infrastructure and they are 2 agencies that are supposed to help and protect consumers. 

So again where is this IT Infrastructure tax?  We can certainly use one as without it inequality will continue to thrive as big business continues to reign without much regulation.  This is an area where big business benefits and the cost should be reflected from that side of the fence and not more tossed upon the consumer.  Consumers also need a federal disclosure page in the name of transparency so we can see who sells what kind of data to who, as right now we are all at the mercy of the crafty written legal privacy statements on websites that are very difficult to interpret for the most part and confuse all and that may be the plan so as not to give out too much information as to what is really happening on servers operating 24/7 making life impacting decisions about all of us.  Our lawmakers seem to be out of touch with all of what goes on behind the scenes as well. 

IBM Watson Going to Work At Citigroup on Wall Street–Congress Didn’t See Big Data As A Tool (Hadoop Framework) When They Had Their Chance…For Consumers The Attack of the Killer Algorithms–Chapter 22

The government needs to keep up with with the IT infrastructure of big business today and big business should foot that bill, not the consumer.  BD

 

The Quiet Rise of Machine Learning-Like IBM Watson Offers With Speed and Learned Analytics-Congress Needs Technology This To Make Better Laws & Collaborate

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UnitedHealthCare 1st Quarter of 2012 Yields over $1 Billion in Net Profits–25% of the Nation Still Remains Uninsured

The Los Angeles Times ran this article today about the “holes in health insurance coverage” and is that where some of the profits lie?   Also noted in the growth was the DOD contract award.  Did this lawsuit have anything to do with the award mentioned in the article as well as hiring the former US Assistant Attorney General from Minnesota as general counsel?   One does have to ask when you see flurries of legal activities. 

Update: UnitedHealthcare Sues Department of Defense Over Tri-Care Contracts–They Said They Would Do This – Is This A Case Of My Algorithms Are Better Than Yours?

 

In addition the company either directly or through subsidiaries is buying up more physician’s practices, HMOs and IPAs so that would seem to leverage greater control on reimbursement to the the doctors. 

United Healthcare Buys Two HMOs in Florida–More Cheap or Free Hearing Aids for Seniors Perhaps–Subsidiary Watch

Meanwhile the AMA put an article out that the United lawsuit checks are in the mail.  Nobody is getting tons of money as they never really do on a class action suit.

”Neither United nor any of the health plans that used its Ingenix databases admitted to any wrongdoing, but they did reach a settlement in the federal lawsuit in 2009, agreeing to pay physicians and patients $350 million.

United and other insurers also reached an agreement with the New York State Attorney General's Office, which had investigated the use of UCR to set payment rates and concluded that the system cheated patients and their physicians. The insurers agreed to change the way they set out-of-network payment rates and pay to establish a new database”

In the Health IT business they have about 3 different medical records programs offered through subsidiaries and have enough analytics to cure what ever ails a doctor, hospital or corporation.  Contract lowered, they have the algorithms to help one function with less.   

Subsidiary Watch-Corporate Conglomerate Insurers Reduce Compensation Contracts Using One Subsidiary Then Market Same MDs With Another Subsidiary in Health IT

 

Here’s a couple other subsidiaries that add to their bottom line, although I believe some of the I3 folks are no longer a part but they still have ChinaGate as a subsidiary in China and maybe this is part of the cheap hearing aides they offer through yet one more subsidiary they set up to distribute them.   More information about the hearing aids at the links above. 

United Healthcare (Optum) Owns A Consulting Firm for FDA Drug and Device Approvals, Clinical Trials–CanReg - Subsidiary Watch

UnitedHealth subsidiary (Ingenix Subsidiary I3) Acquires ChinaGate – Working to Sell Chinese Products Globally

Other insurers are due to come out with their numbers soon, but nobody has the huge daily chain of subsidiaries to compile revenue as does United and they don’t have a bank as United does with over $1 billion on deposit.  BD 

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First-quarter net income rose 3.1 percent to $1.39 billion, or $1.31 a share, UnitedHealth said in its statement. The results beat the $1.17-a-share average of analysts’ estimates compiled by Bloomberg. Revenue climbed to $27.3 billion from $25.4 billion a year earlier.

UnitedHealth spent 81 percent of premiums collected on medical care, down from 81.4 percent a year earlier.

Hemsley has been bulking up with acquisitions of smaller health plans as President Barack Obama’s health-care law puts pressure on profit margins. UnitedHealth completed its $2 billion purchase of XL Health Corp. in February, gaining membership in plans administered for Medicare, the U.S. backed program for the elderly. Last month, the Pentagon announced it had chosen the company for a $20.5 billion, five-year contract to provide benefits to military personnel and their families.

http://www.bloomberg.com/news/2012-04-19/unitedhealth-profit-rises-as-medical-costs-lag-behind-recovery.html

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Scientists in Japan Use Stem Cells to Grow Hair on Bald Mouse–Hair Grew Within 3 Weeks Video

If you read the entire article here the scientists were able to play around too with the density and color of the hair grown.  They also used human cells and the mouse grew human hair.  This could be the future therapy for baldness and researchers say we are a few years away from use on humans. 

The also said that to use this treatment for a large area of hair would almost be impossible to do but it can certainly be used to fill in bald spots.  BD 

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Could hair follicle stem cells help people regrow their hair after losing it due to disease? Japanese scientists' recent successful experiments on bald mice suggest it's possible.

The Wall Street Journal reported that after a team of researchers at Tokyo University of Science transplanted two different kinds of cells from mice hair follicles into a bald mouse's follicles, almost three quarters of them sprouted hair within three weeks.

http://www.nbcchicago.com/news/health/NATL-Hair-Loss-Baldness-Cure-Regrowth-Stem-Cells-Bald-Mice-148077255.html

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“Think Tanks and Consultants” With Creative Solutions Running Faster Than What Today’s IT Work Force and CIOs Can Keep Up With–“Time Bankruptcy”

This was a good write up from Dr. Halamka  at Harvard Medical from his blog, “Life As A Healthcare CIO” and he’ very down to earth with his comments.  If you have followed his blog or caught his many appearance all over the web then you know he is the top of ladder here with knowledge and enthusiasm for healthcare technology and it doesn’t get any better with true evaluative information that he puts out.  He does a good job with both the good and the bad and more importantly, reality. 

Dr. Halamka is one of those rare “hybrids” among us out there that we need to really listen to as having both a computer science (and more than that) degree and being a practicing MD as well as a CIO is a lot wrapped up in one person.  Bill Gates told the graduating class at Berkeley the same thing, “be a hybrid as those are the folks in the world with real value and being able to have more than one focus. 

What makes this interesting is the fact that a former CIO from a hospital who has now moved on into private consulting create and suggests a solution, and I don’t know how long she has been away from the hospitals but it certainly might sound like it’s long enough to not be in touch with the havoc and speed that has taken over in this last year. 

The proposition about a collaborate data center was according to his blog post was well received, but the secondary input here…who has the time. I guess in the world of technology those outside of the “code” realm, who have never written a stick of code or been in any part of networking from the IT side have no clue as to the time it takes today with all the aggregated data we have out there, not to mention security that requires constant attention.  Us tech folks might be to blame for some of that from the other side of the coin as we made it look so easy for years, but things have changed and we can’t do the over night and quick miracles that folks have seen in the past.

It is not just the layman either, some CEOs still think that way, so in essence it’s nice to have all the brainstorming and great ideas that come out of some of these session, but remember to be kind to your tech folks and “ask” them how long and what the process is.  I have to say no sometimes to the “I wants” of the folks that I work with and it could be both “time” and “expense” or I find they want something that is not needed.  If you are an IT person the “non needed” will definitely bring a chuckle or two. 

You can create many “proofs of concept” but if the folks that do the work and planning don’t have the time, then you might think again about the “I wants” and go back to the drawing board.  Out of meetings though too come some technologies that really are needed and most IT folks recognize good ideas and “if they have the time” in the mix of everything else they do, they will jump on it. 

I’m glad he brought this topic up and if you don’t think your CIOs are up to capacity, think again about time elements and burning them out.  This is not new but has been going on for a long time.  Politicians are great ones for the “I wants” with being clueless as to the time an research needed from CIOs and want answers that are not there too.  Here’s a refresher on the ICD-10 case that he wrote back in August of 2011.  This is a pretty lengthy article that brings in more than just my input. 

Dr. Halamka Speaks About Health IT–“CIOs are on Overload” and It Would be A Blessing to Stall Off ICD-10 to 2016 - The Straw Breaking the Camel’s Back

 

CIOs and many Health IT folks are “bankrupted for time” and how about the “think tanks”, CEOS and others taking that thought to heart?  BD 

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Meg Aranow, the former CIO of Boston Medical Center and now a principal at Aranow Consulting recently assembled several of the IT leaders in Boston to discuss opportunities for reducing costs and enhancing infrastructure by pooling our collective resources.   Here's her guest post describing the exploration:
"I recently met with IT leadership from Partners Healthcare, Children's Hospital Boston and Beth Israel Deaconess, all teaching affiliates of Harvard.  The topic around which we convened was to discuss the idea of a collaborative datacenter.

We concluded the meeting thinking it might be an interesting idea to some day explore if there were time.  But not now. "

Thanks for doing this Meg.  In a world of infinite demand and limited IT supply, all CIOs feel "time bankrupt".   The alignment of opportunity, regulatory mandate, cost pressures,  politics, and prioritization is definitely a perfect storm that occurs only rarely.

http://geekdoctor.blogspot.com/2012/04/brainstorming-about-collaborative-data.html

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Jackson Memorial Hospital Begins Major Layoffs to Save Money–Around 1000 Expected and Some Can Return to Work as Part Time, Some Benefits (Video)

The math in the article goes like this, 1115 get cut and 350 part time jobs get added so the folks getting laid off get a chance to return part time, so I’m guessing this is 30 hours or less a week.  $70 million is the dollar amount to be saved.  The video did not say what the “benefits” were for the part time employees but one might guess they may not be the same as full time employees get.


Over 900 pink slips have already gone out.  One doctor states it was already affecting patient care as there are less people.  The transplant floor and the burn units are two departments that have been affected.  Patient volume has been decreasing. BD

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MIAMI (CBS4) – More than 920 Jackson Memorial Hospital employees could be out of a job by the end of the month. The hospital gave out pink slips last week and some employees argue the affects are already apparent.

“At least in Jackson it’s getting everybody’s morale down,” said Dr. Morad Askari, a plastic surgeon. “It is in some regards definitely affecting patient care.”

O’Dell said the patient volume has been declining steadily over the past few years and the cutbacks are an effort to operate more efficiently.

JMH believes it will save nearly $70 million by cutting a total of 1115 positions, some of them currently vacant, and adding in 350 part-time jobs.

“Part-time employees come and they don’t have anything invested in to the hospital and what our mission is and what we’re trying to accomplish,” said Dr. Askari.

http://miami.cbslocal.com/2012/04/16/jmh-layoffs-sparking-more-questions-than-answers/

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What’s Going on With Warren Buffett and His Prostate Cancer? Did He Choose To Be Screened?

I have been reading the news like everyone else out here and kind of wonder the same thing and as the news unfolds, I understand this is a phase one from the results of a PSA test.  It’s odd as any more they don’t recommend the test for men over 75 and the radiation he has agreed to take as treatment could be very rough on him and the risk of harm goes up. 

A study showed from autopsy data that 70% of men 80 and beyond had prostate cancer so he’s very much alive but right up in that age bracket.  The American Cancer Society said back in 2009 that benefits of detecting many cancers has been overstated.  BD 

American Cancer Society – Benefits of Detecting Many Cancers Has Been Overstated

“The very idea that some cancers are not dangerous and some might actually go away on their own can be hard to swallow, researchers say.”

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A day after Warren Buffett announced he had prostate cancer, the question on the minds of many men and their doctors is this: “Why was an 81-year-old man screened for the disease in the first place?”

Mr. Buffett’s cancer was detected with a prostate specific antigen blood test, commonly called a P.S.A. test.

But the decision by Mr. Buffett’s doctors to screen him at all goes against the recommendations of the highly regarded United States Preventive Services Task Force, a government panel that issues screening guidelines.

Not every medical group opposes P.S.A. testing of older men. The American Academy of Family Physicians says that P.S.A. testing “may be stopped” at age 75, or when life expectancy is less than 10 years. The American Cancer Society and the American Urological Association discourage screening for men whose life expectancy is 10 years or less, but suggest that a man who is expected to live 10 years or longer discuss the risks and benefits of testing with his doctor.

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Merck Could Pay as Much as $1 Billion for Endocyte Cancer Drug To Develop and Commercialize The Experimental Drug

Vintafolide is the name of the drug and it comes along with a companion diagnostic test to determine if patients would benefit so we get a taste of personalized medicine along with the drug development.  Merck like other pharmaceutical companies is looking for additional revenue as some of their best sellers come off patent. 

Vintafolide is a chemotherapy derivative and targets cancer cells that over express folic acid receptors.  Ovarian cancer as well as small cell lung cancers are the study groups and intended use.  The drug has orphan status in Europe presently. 

Johnson and Johnson as we know has had a shortage of Doxil which is part of the process with this drug’s development and has added on to the trials times.  BD 

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Merck & Co. (MRK) agreed to pay $120 million upfront--and an additional $880 million if certain milestones are met--to Endocyte Inc. (ECYT) for rights to develop and commercialize

Endocyte's experimental cancer drug vintafolide.

The deal's potential $1 billion value underscores rising interest among big drug makers in so-called personalized medicine, which includes drugs that target diseases with certain genetic or biological traits. Vintafolide is being developed with a companion diagnostic test that would help determine which patients could benefit from treatment.

Vintafolide, also known as EC145, is being evaluated in a late-stage clinical trial for ovarian cancer and a mid-stage study for non-small-cell lung cancer. The companies said the deal contemplates vintafolide's use in six cancer indications.

Vintafolide combines a compound known as a folate, or vitamin B9, with a form of chemotherapy. It is designed to target fast-growing cancer cells that actively take up the folate via a folate receptor. The companies said a wide variety of cancers express this folate receptor, including ovarian, lung, breast, colon and kidney.

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FDA and Smart Phone Devices Struggle With Applications and Regulations–Get More Engineers at the FDA and Don’t Rush the Developers With Medical Software

mHealth is getting pretty sophisticated and actually the FDA is doing a decent job as evaluating what they need to regulate and what is in fact a simple “consumer” application; however as more applications connect to PHRs and EHRs the simple “consumer” application not requiring FDA approval may stand to shrink a bit. 

When it comes to sophisticated devices that are beyond reminders and simple readings, it’s actually in our best interest to have the FDA take look.  One thing to note is that when creating devices that contain sophisticated software today, you do not rush the developers and this is kind of unspoken and you know it happens when a company has announced an upcoming product and the pressure is on to get it to market.  In the interim though, you never know what bugs or other glitches might come up in the software and that can set the date back.  If developers want more time due to this issue, give it to them and don’t push and let them debug as much as needed.  We all want devices out sooner but this is where you do not push as you might meet the deadline but the software may not be as good an debugged as it would if developers were allowed the time they need.

Thus, I come back and issue a word of warning to not push the software side to go faster as regrets can and have come later.  Back in 2010 I said the FDA can use all the engineers they can get their hands on and like business in the US, they are hard to come by sometimes.  If you are going to college, learn to code and become a software engineer, please.  We don’t want to be “beta” testers out there with potential life saving devices. 

FDA and Medical Devices-Who Doesn’t Get This, They Are Looking for Engineers Just Like Technology Companies Are Doing- Get Some Congressional Digital Literacy in Place

 

Having another set of hands at the FDA with wireless devices that transmit data is not a bad thing at all to have more look at the product.  It is also a good idea to look at the marketing too of such products.  Doing this blog I see all kinds of stuff out there and coming up with a policy to stay within the realms of what some products do is a good idea.   

Many of the tech wizards aren’t used to FDA supervision. And now, both sides are struggling to figure out how to live with each other.

Who knows we could as technologies grow see more of an alliance with the ONC division of HHS too as they are connected.  Actually a couple years ago in 2010 I said the FDA stands to be one of the “most connected” federal agencies and it’s certainly moving in that direction as it’s where the technology is.  BD   

FDA and FCC To Partner on Telehealth Innovation and Implementation – FDA Stands to Become One of the “Most Connected” Federal Agencies

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An onslaught of mobile health technology has forced an arranged marriage between smartphone app makers and the Food and Drug Administration — because someone had to regulate them.

There’s just one problem:

It’s a regulatory clash that grew out of a burgeoning revolution in medical technology. Thousands of health-related apps are on the market already. Some help people manage their diets or workouts or take their pulse. FDA has said it doesn’t intend to regulate such “health and wellness” apps.

The mHealth Coalition has asked FDA to delay finalizing the draft guidance on these controversial points, saying the agency should continue to work through the issues until they have a sturdy framework that can accommodate the rapid pace of innovation in the sector.

Perhaps the biggest challenge on FDA’s side of the equation is figuring out how to handle devices that provide information to help doctors make decisions — an old issue that’s not specific to wireless devices but one that’s not getting any easier to address. Remote monitoring has been around for 20 years, Patel said, but the technology has grown far more sophisticated and is raising new questions. 

http://www.politico.com/news/stories/0412/75207_Page3.html#ixzz1sPxAxy8X

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Heart Disease Is Not An Indicator of Heart Problems States Doctors Who Want to Set the Record Straight at the American Heart Association–Killer Algorithms Chapter 27 Flawed Math and Studies

How many times have we heard this over the last few years, many if you read the news.  Having an infection though, just like anywhere else in your body could lead the infection to go anywhere in your body so as far as bacteria though the American Heart Association says all the information is flawed.  This goes right along with I talk about all the time, “flawed data” and it’s amongst us.  Good thing we have folks that find it too and let us know.  I can’t wait for the day that I have my teeth regrow themselves with stem cells!  What great way for dental work and getting a tooth replaced.  I just wondered though if the stem cells would grow cavities back but was told “that is a good question”.  Rats are getting new teeth.

Rats Are Getting Teeth Re-Implanted With Stem Cells and Same Technology Can Be Used for Replacement Teeth

This goes back to how studies are done and anyone can crank out numbers and I talk about that and how sometimes we have marketing folks that will spin report numbers or we have a very small study in which there’s not enough proof to speak of and everyone thinks it’s the gospel.  So brushing your teeth is not going to help you avoid heart trouble but it will help your oral hygiene and clean the bacteria out of your mouth.  We still have the same old problem of negative studies not being published as well so journals still struggle at times to have all the information included. 

Scroll down on the left hand side and watch this fantastic video about how naïve we are are and how we get fooled.  You wont think the same about studies again.  There are good ones out there but the challenge is to tell the difference sometimes. 

Look for the Attack of the Killer Algorithms as that’s exactly what we have here with crunching numbers sometimes.  

What is very cool though of late is that I have the National Institute of Statistical Sciences following the Killer Algorithm series and they wrote to me recently and said “keep it up” we like and agree.  BD   

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(Reuters) - For 20 years, researchers have reported a link between gum disease and heart attacks or stroke, but a new analysis finds that claim seriously flawed - so much so that the American Heart Association (AHA) issued a rare "scientific statement" on Wednesday concluding that gum disease has not been shown to raise the risk of, let alone cause, cardiovascular illness

AAP President Pamela McClain, a periodontist in Aurora, Colorado, agreed that research has "not been able to say that periodontal disease causes cardiovascular disease." Gum disease "is a risk factor, and observational studies have supported an association but not a causal one." She said she did not see a need to revise the group's website.

Besides correcting the scientific record, the AHA panel hopes that publicizing its conclusion will help people. Most important, said Bolger, if people understand that periodontal disease does not raise their risk of heart attack and stroke they can focus on what does, such as smoking, obesity, high blood pressure, and stress.

http://in.reuters.com/article/2012/04/18/us-usa-health-gums-idINBRE83H1AC20120418?feedType=RSS&feedName=health&utm_source=dlvr.it&utm_medium=twitter&dlvrit=309303

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UnitedHealthCare Sends Letter to Teenager Telling Her She Had Diabetes With No Parent or Doctor Involvement–Only Blood Test Was For Lyme Disease–Analytic Attack of the Killer Algorithms?–Reader Writes

I have take the comment left by anonymous reader here and it’s worth a read and looking at.  If all of this contained here is in fact right to the point and factual then it’s a new “low” on the part of insurers.  I can’t imagine a teenager getting this type of a letter without first notifying their doctor.  Did they jump the gun before the patient had a chance to meet with their doctor and send this letter out?  No matter how it happened, we have a huge break down with ethics here and the doctor/patient relationship and in this case add the parents in here too as they were not notified. 

When you read further here you can see there’s an admittance of a blood test for Lyme disease and that is whole different test than testing for glucose and blood sugar levels.   With a glucose test there’s usually a “fasting” period required, depending on the type of the test and a Lyme test would not require this as they would be looking for antibodies and not sugar.

I don’t know if I will hear back on this or not but I wrote a post about a year ago on the more aggressive analytics the company was implementing and this is where the comment was made today.  Below is a quote from the press release last year as well. 

United Healthcare Expanding Diabetes Prevention & Predictive Algorithm Program With Walgreens And Pay for Performance Incentives In Atlanta

“The prevention arm will use UnitedHealth claims data and other demographic information to flag people at risk of developing diabetes and invite them to a free, 16-session exercise and nutrition class at a local YMCA. They’ll have monthly follow-up after the class is over, and instructors will be paid bonuses if participants meet certain modest weight-loss goals.”

 
The company is convinced that pay for performance is the answer to almost all healthcare woes as today there was a press release talking about a new Cancer Payment Model paying physicians for health outcomes.  I don’t know about you but when I read the press release it almost sounds like they think the cures for cancer are here today and are somewhat implicating patient survival rates in here somewhere as reducing cost is right in there too.  They talk about the “buy and bill” to where oncologist buy the more expensive drugs and keep them on hand and bill for them. 

Many of the MDs I know don’t do much in office chemo any longer as they were cut a few years ago with reimbursement and now can’t afford the wait time for claims to be paid and some were not getting reimbursed at all if the analytics of the insurance company decided later not to pay.  It may be different in other states but so many in California couldn’t afford it anymore.  Let’s also not forget we have a chemo drug shortage going on too which doesn’t affect all cancer treatments but enough to be declared a shortage as patients are not getting their treatments on time or all the time. 

Back on track, this is a good read here and let’s hope someone is working on fixing this so the “letter algorithms” don’t start kicking out cold crappy letters like this and again you wonder as the parent of the teenager makes note of, how much privacy is here?  I really do hope to hear back for an update here to see if it really is diabetes, pre-diabetes and how the blood test algorithm kicked out this letter without first getting in touch with the patient’s doctors.  This is a brand new low from insurers. 

Aetna too has been having problems with their algorithms keeping track of who and who is not in network with mailing 8000 folks in California that their doctor was no longer in network and they admitted it was an error, but all the while 150 doctors in Texas found out there were getting cut out, so insurers and their algorithms. 

 

When you hear stuff like this it’s one more Attack of the Killer Algorithms, below is the reader comment….BD 

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“Our teenage daughter just received a letter from UHC saying she had Diabetes!    None of her healthcare providers have ever mentioned this!
The United Healthcare letter has this at top:
"you have diabetes. You know it. And that means you can control it."
The letter then says Dear so and so, Our medical records indicate you may have diabetes, and that puts you in a perfect position to do something about it...".....Enroll in the Diabetes Control Program.

Can you imagine receiving a letter from your insurance company stating that you or a loved one has a disease that you have never worried about before?
Ironically, this will provoke me into getting my daughter a Doctor's appt and tested asap.

What a mean and inappropriate way to scare people. If there IS any evidence that my daughter has diabetes, why didn't UHC send us a personal note with the evidence?

Why have none of the providers who have seen our daughter and that UHC reimbursed and paid never mentioned this to any of us? Never. Are they randomly sampling blood given for other tests? Our daughter had a Lyme disease test in March, not a glucose test.

It raises some serious questions, don't you think? How private is your blood? How safe is your insurance company regarding data mining and manipulation of unnecessary tests.

I hope our daughter doesn't have diabetes, but if God forbid she does, what a hell of a way to find out about it. If she's fine, then I have a lot more questions and comments about UHC sending us this letter. “

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Personal Health Records Come In Many Flavors Today and Are Worth Having–Even If It Is Not Complete and Perfect

The article is from Information Week and I agree as I thought PHRs were great when announced.  I have a very small file but I also have my 87 year old mother with a PHR that is really good to have and we add to it from time to time and we have the basics in there, medications and allergies if nothing else are the top priorities for others to know as one or the other without enough information is enough to potentially kill or harm you with medical care.  There are both “tethered” and “non tethered” PHRs and for me, being I’m not part of a large group like Kaiser, the non tethered works for me.

I would not want one from an insurance company; however I would take all the information they had to offer in one way download file for sure.  It’s always good to see what is on file and sometimes you find mistakes too so with any PHR if you are offered information from a medical concern or insurance company that goes one way, take it.  Since Google Health and HeatlhVault started I began the section for PHRs on this blog and about 80% of the articles in that section are those two and I explored how bar coding can get in there too. 

Way back in October of 2009 I even spoke with Curtis Schroeder from Bumrungrad Hospital as they were attending the first International Tourism Conference here in Los Angeles.  I recorded the interview with my phone and this was long before all were doing live broadcasts via phone.  Since QIK has now been bought by Microsoft and Skype I noticed my video is now gone..boo..but you can read my write up here.  That’s what I get for being ahead of my time:)

Interview with Curtis Schroeder, CEO Bumrungrad International Hospital and Nate McLemore, Health Solutions at Microsoft – International Personal Health Records with HealthVault

 

Also HealthVault has a cloud imaging viewer now too and it makes it real simple.  Some ER rooms don’t even have a dicom viewer on the PCs so with this just download the program and it’s there.  We all know how expensive and time consuming imaging tests are so if you don’t have to repeat one it’s easier on the patients and less expensive as well. 

HealthVault Begins Storing Medical Images (Dicom) Using Windows Azure Cloud Services With Full Encryption

It just all depends on the individual and organizations like Kaiser Permanente pre-populate a lot of the information and thus make it easy for the patient and actually they are more of the “portal” style of a PHR.  Back in 2010 I interviewed Dr. Richards from Kaiser who spoke both of how the PHR works for patients and how the EHR coordinates for her use, a win-win. 

Kaiser Permanente Pediatrician Patricia Richards Explains How The Use of Electronic Medical Records Enhances Knowledge With Obesity and Adds Focus to the “Let’s Move” Obesity Prevention Campaign

 

Microsoft just announced today the expansion of HealthVault to Germany and another newcomer, MMRGlobal (MyMedicalRecords.com) continues to grow their PHR business with a little different business model.  They have a few different things happening and the PHR is not free but cost very little and has the capability to integrate with EMRs and they have a set up for doctor’s offices to lease to help in the set up, as well all know that’s what takes time.  They provide a full document service to get the paper in the files.  I’m kind of glad I looked over there again as it has been a while they also integrate with the Blue Button Campaign for Veterans and provide a 90 free trial of their PHR with it, not bad.  The monthly charge is $9.95 and you get some phone support…that’s nice and you can add your pets too.  I see they also have faxing which I have used with HealthVault a while back.  You can read more at the website.  BD

“MyMedicalRecords gives you the powerful ability to upload images such as x-rays, scans and MRIs into your account directly from your PC.  So in addition to documents, MMR lets you store pictures as well.

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Another reason for not using PHRs, readers said, was the inconvenience of using such programs, which require too many passwords, mouse clicks, and related hurdles. One IT pro, was commenting specifically about patient portals, said that in his experience, patients would much rather use simple email to communicate with their doctor then jump through all the hoops required to enter data into a portal. In his words, "After a year and a half of really aggressively recruiting our patients to sign up for the portal, we got only 10% signed up. My gut feeling is that the process of using the portal is just too complex and inconvenient."

That's quite a list of negatives: mistrust, apathy, inconvenience, and fear of data breaches. Will PHR providers ever overcome them all? Not anytime soon, but despite all these concerns, I still believe the benefits of a PHR outweigh its risks for many patients--especially adults with chronic disorders and the parents of children with life-threatening diseases.

http://www.informationweek.com/news/healthcare/patient/232900330

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Prototype Firewall for Medical Devices to Stop Hacking in Development at Purdue and Princeton Universities

This is a bit of good news with what we have been reading in the news that there’s potential relief on the way.  It would be a small separate device that one would wear or have in their cell phone called the MedMon.
Pacemakers and glucose devices are the potential vulnerable devices as they are deployed in large numbers everywhere.  It could also be extended to brain implants in time.  BD

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U.S. researchers say a prototype firewall can keep hackers from interfering with wireless  medical devices such as pacemakers and insulin-delivery systems.

A team of scientists from Purdue and Princeton universities had previously demonstrated how medical devices could be hacked, potentially leading to catastrophic consequences.

"You could imagine all sorts of scary possibilities," Anand Raghunathan, a Purdue professor of electrical and computer  engineering, said. "What motivated us to work on this problem was the ease with which we were able to break into wireless medical systems."

http://www.sci-tech-today.com/news/Firewall-Stops-Medical-Device-Hacking/story.xhtml?story_id=10000C81W41W

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