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FDA Approves Merck Victrelis Oral Hepatitis C Virus Inhibitor–New Class of Medicine

5/14/2011 12:50:00 AM  ,  

Hepatitis C is getting some good news as last month another drug went into clinical trials.  Also Merck will include VICTRELIS  in the patient assistance program through which eligible patients may be able to receive product free of charge.  This is the imagefirst  new treatment in 20 years.  In the trials more than 65% of the patients were cured, good news there.  The dosage is taken 3 times a day, a pill with meals. 

Boehringer Ingelheim Receives FDA Fast Track Approval for Hepatitis C Virus Treatment and Moves In To Phase 3 Trials

Hepatitis C is the primary cause of liver transplants un the US so sales are predicted to be pretty large with over 3 million in the US having the disease.  One of the benefits of the drug is that the length of time for a cure is less than current treatments.  BD 

WHITEHOUSE STATION, N.J., May 13, 2011 – Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

VICTRELIS is the first in a new class of medicines known as hepatitis C virus (HCV) protease inhibitors approved for use in combination with peginterferon alfa and ribavirin, which is the current standard therapy, for the treatment of chronic hepatitis C.

“Compared to current standard therapy, VICTRELIS can significantly increase a patient’s chance of achieving undetectable levels of the virus, thereby obtaining an SVR. For many patients, VICTRELIS may allow for a shorter total duration of treatment.”

Merck will begin shipping VICTRELIS to pharmacies within a week so that patients will have access to this new medication as soon as possible. In addition, the company is expanding its support of public awareness and education programs for chronic hepatitis C. Resources include coupons to help eligible patients with their medication cost, reimbursement support to help patients understand their insurance coverage for VICTRELIS, and 24/7 nurse phone support.

http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0513.html?WT.svl=content&WT.pi=content+Views

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Regulation Of Stem cell Medicine–What Is the Future with the FDA

5/13/2011 11:40:00 PM  ,  

Since stem cell research and development is moving so fast, this article brings up a lot of good questions as to how regulation will or will not take place.  As the rules/laws read, culturing stem cells in the eye of the FDA is considered a “drug”.  The article talks about a “tool kit” being in place in a few years at a physician’s office.  Guidelines are being developed by the American Stem Cell Therapy Association for safe use, like fertility clinics where state laws would have jurisdiction.   image

Stem cells are taken from the patient and injected back, no cells from outside sources and this kind of reminds me a bit of the Provenge cycle with the anti immune drug with being processed and re-injected so in time we will have entirely new classes of drugs and treatments for a lot less cost potentially.  One remark made here too is the fact that a $60 billion dollar drug and device care system would be in time reduced to a $6 Billion dollar stem cell business and of course there’s not much more that needs to be said there with the number of drug and device companies in business, although not all would go away but the number of devices and drugs that we used today could shrink.  BD 

Within the next five years, it’s quite possible that physicians will come into routine possession of a remarkable set of tools   — a brand new way of dealing with the frailty and disabilities of aging.  The tool kit is autologous stem cells derived from the patients themselves, amplified in culture, and infused back into the patient according to a precise protocol.  It would be such a leap from today’s medical diagnostics and treatments; it could only be called revolutionary.

The purpose of employing autologous cells is to prevent rejection of histo-incompatible cells by the patient’s immune system. But it’s also possible that these new therapies could slip from our grasp, at least in the US. If we’re not careful, these therapies could become the exclusive domain of the pharmaceutical industry, as regulated by the Federal Food and Drug Administration  (FDA). This could push the availability of this tool kit 15 to 20 years into the future. The opportunity-cost in terms of morbidity and mortality could be catastrophic.

We’ve got an organization to formulate guidelines, and we’ve got clinicians working to form a stem-cell registry. But the FDA doesn’t appreciate that. We only do adult cells from the same person. But the FDA contends that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug.” He points out that the age-management community has seen many instances where the FDA has tried to insert itself into the practice of medicine — although this has been strictly prohibited by Congress — and this is just the latest. “Compounding pharmacies have been coming under FDA pressure for a long time, and have now organized and set up their own standards and guidelines as a way to combat that interference.”

“You’re talking about replacing $60 billion in drug- and device-care with $6 billion in stem-cell care,” Dr. Centeno observes.

Will the FDA Kill Adult Stem Cell Medicine? | medical students exam Blog

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Tenet Healthcare Seeking Damages and Costs for Resistance of Hostile

5/13/2011 11:03:00 PM  ,  

The Community Health Take over is now done and Tenet is now seeking the expenses and administrative costs created by the take over attempt as Tenet refused the final offer.  Tenet will be filing a lawsuit.  Also remember back when Tenet stated they had evidence of potential fraud with Community, HHS also decided to take a look inside so no word on whether or not the government will still be investigating  I think everyone was pretty tired of the situation and read somewhere too that even citizens in Tennessee where CHS is located were not happy with all of the ruckus, in other words it was just a corporate blood bath war that stands to raise the cost of what we pay for hospital care in the long run.  BD 

Tenet Files Suit Accusing Community Health Of Inflating Hospital Admissions

Tenet Healthcare Corp. (THC) will seek damages for the cost of resisting Community Health Systems Inc. now-terminated takeover bid, a Tenet lawyer said.

Community Health dropped a $7.3 billion offer to buy Dallas-based Tenet on May 10 after Tenet had rejected a takeover three times. Community Health, the second-largest U.S. hospital operator, also withdrew a slate of 10 nominees for Tenet’s board.

While fending off the offer, Tenet had sued Franklin, Tennessee-based Community Health, alleging the hospital operator systematically admitted patients for financial rather than medical purposes and overcharged Medicare.

“They have withdrawn their slate of officers, so that issue has gone away,” Rob Walters, the lawyer for Tenet, said after a hearing in federal court today in Dallas. “We still have the costs and economic impacts associated with the effort they made.”

Tenet Healthcare Seeks Damages for Fending Off Community Health Buyout Bid - Bloomberg

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Newt Gingrich Announcement–Jon Stewart Commentary About Using Twitter And History on Scamming Doctors for Money (Video)

5/13/2011 02:38:00 PM  ,  

He doesn’t get those algorithms:)  We know that for sure!  Everything we hear is back to the 70s, which is what makes this video from Jon Stewart so contagiously funny!  At the link below there’s another video that tells the whole story, so if you are a doctor and if these letters are still floating around out there, don’t touch and read the comments below from one doctor who commented about receiving one of them and how he feels Newt even scams HIMMS by showing image[6]up to talk:)

Newt Gingrich Scams Doctors With Fake Prize Awards That Costs $5000

“I got that invite! The scam even promises a free meal. I never got to the point where $5000 was requested, but the letter was enticing, making one feel important with the personal handwriting.
Newt is not only a con-artist, but he's a jerk. In the EMR world he is also scamming HIMSS by his support, getting heavy lobbying money which buys him an occasional key speakership roll in the yearly HIMSS bashes. Unfortunately, that eventually affects doctors by giving the EHR industry a backing from the Republican party too.”

American Solutions for Winning the Future is his fundraising group that creates money for Newt.  It will cost you $5000 if you are a doctor to get an invite and an award from Newt Gingrich.  It is funny in the video that they use the a handwriting computer font. 

If you want a little more history on the topic of healthcare algorithms and where he stands and his analytical power, one more link from the Quack archives below.  BD

Newt Gingrich Gets Healthcare Value Bass Ackwards–It’s All About Those Algorithms

Anyway if you read here often enough you know how I feel about those who don’t use any modern day intelligence and have no concept of Health IT infrastructure – FAIL!  John says using Twitter is not going to make young people like him and he is not “cool” <grin>.  The Twitter deal Jon says is not going to work for him as he is “square’.    After reading the comments on the doctor scam, it doesn’t look like they will like him either.  BD 

Cheap Soap Opera Political Antics Again With Newt Gingrich Suggesting to Force Kathleen Sebelius out of HHS And Other Extra Ordinary Tales of Non Participating Illiterates

Newt Gingrich launches his state-of-the-art presidential campaign in a Sears photo studio with Casio accompaniment.

The NeverTrending Story - The Daily Show with Jon Stewart - 05/12/11 - Video Clip | Comedy Central

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Three Prominent Organizations Support Court's Decision that Obamacare is Unconstitutional-A Case for Better Predictive Modeling and Behavior Analytics

5/13/2011 12:36:00 PM  , ,  

Predictive modeling and behavior analytics is a part of life and business today and they are used for both “accurate” results and “desired” results and the 2 should be the same –but not always as we are growing to see.  I try and do my best to discuss this reality as I interpret based on what’s happening in the healthcare business.

We have a missing element here and that was the “public option” and if in fact that had been included we may not be at this cross roads today, plain and simple.  In some areas of the country the only options for individuals is a “publicly traded company” so again this is the rub and without an option from the government where people could choose, it’s a bit hard to enforce and myself I would like the option to either choose public option that perhaps was run by a “non profit”, and this is not to be confused with a “not for profit” as they are 2 different entities, but they could also exist as on option.  Forcing individuals to purchase health insurance from a publicly traded company is again the rub.  To be fair that option should be available for those who want that option as well. 

Florida Judge Rules Against Health Law– Need Some Judicial “Algo Men” to Influence Decisions on Costs With Methodology Entailment and IT Systems Functionality

The law is over a year old and technologies and business intelligence systems have changed in a big way over the last year and you would have to almost be living under a rock not to see at least part of this as with data systems and analysis processes all aggregated and connected, you will feel or see some impact as it comes down to decision making processes.  The healthcare law has many good provisions too and most do in fact benefit the consumer but this one tough section of no public option has created havoc in more ways than one.  We are known as a nation of negotiations and everyone does not get 100% of what they want and thus it’s time to sit down again and take a second look.  The President understands this and he’s open to talk but again remember he’s not the final word here, Congress is. 

We have also had a ton of mergers and acquisitions over the last couple of years and that changes the face of laws and business continuously. The Supreme Court doesn’t appear to want the “hot potato”, and frankly who does with all the data and information that needs to be included in an accurate decision making process to ensure we get an “accurate” decision and not one strictly based on “desire” of big corporations. 

Supreme Court Rejects Call To Review Healthcare Law–Perhaps Added Time To Invest In New Technologies to Query, Sort and Analyze Mountains of Information

It comes back around to technological systems that can sort and bring all the information forward in a way that we, as humans, can analyze and look at it before interpreting.  We have heard the stories that come up about a potential conflict of interest due to the fact that perhaps a judge didn’t keep up with his/her own investments with mergers and acquisitions, and there will be more.

Healthcare Reform Law– Is Any Judge Fully Capable of A Decision on a Law That is Challenged By Constantly Changing Algorithms?

One book I have recommended on this blog in many posts and will take time here to do it again is the one listed below so you can as a consumer get an idea as to where mathematical formulas are going today and their potential impact.  It is what it is and until we all have the same tools for battle and negotiation, the side without is going to lose. 

“Proofiness–The Dark Side of Mathematical Deception”–Created by Those Algorithms–New Book Coming Out Soon

The Healthcare Law in it’s entirety is not bad; however there are adjustments that need to be made as it’s playing out very well as passed by Congress.  A law gets passed and big companies can take as little as 48 hours to roll out a new business model or direct a new model to specific areas of their business, it’s done all the time. 

Healthcare Law Is Not Bad; However Algorithmically Changed Business Models Coupled With Mergers and Acquisitions Change the Insurance Governance Frequently

So we come right back to technology and digital literacy on those we elect today with this being a big factor. We want “accurate” information and transparency is working to move that forward and when transparency efforts reveal what’s happened behind the scenes, we may not like it, some are exposed and then we have new grounds to consider for interpretations and need to do some predictive modeling before laws are passed to avoid the “unintentional consequences” that we all hate.  We will never get rid of all of them, but if we can be smarter from the offset, less will get hurt.  Thus one more time I come back to the request to increase digital literacy on the part of lawmakers.  If methodologies as such has been used a year ago, would they have seen this outcome of disaster with the law being challenged with no public option for one? 

IBM Makes 'Watson' Servers Even Smarter With More Cores–We Are Now Graduating to Taking “Dull” Knives to Gun Battles–There’s No Great White Hope for Budgets

I do apologize if you get tired of the word “algorithms” around this place but it simple is what it is and the techniques are used by all so if we can accept that is how others are doing business, making money and sadly at sometimes taking advantage of our ignorance in this area and inability to focus, then we can move forward I think.  By using effective collaboration and rocket speed technology where everyone sees the same thing at the same time, we could come up with some better decisions at at least reduce the soap opera we see out there.

Bottom line here is that if we do not get smarter about the laws we make, they will become useless and not enforceable, so in that case what have we done?  We can keep the news ratings alive with stores that don’t always make sense based on “weird interpretations” and those are out there by the number for sure. We certainly need a Congress that can see the value of technology beyond IBM Watson just being a “game” and I think due to the fact that it was used on a game show, some of our lawmakers missed the value and only saw the technology as being good for games. 

IBM Watson Did Get a Chance to Go To Congress-Should be a Permanent Home For Greater Intelligence for Creating Laws

Anyway, you can read the press release below and see the points made by this group and I partially agree with some of their points and again in my opinion, what brought all of this forward was the inability of Congress to model and project this on “big white screens” to see the potential result. 

When making decisions with such big impact today, you don’t run off to hide behind closed doors to discuss and be swayed by lobbyists.  As a matter of fact a reversal of this process would be in order to have everyone see and hear the same stats, reports, modeling projections at once, all parties, and then go off to committees to discuss and all would be 100% better educated and better informed to create better and effective laws. 

Time for some new lawmaking and judicial paradigms?  I think so. 

This applies all the way around for all but the GOP more so than the Democrats have still been a bit misguided in thinking there’s a great white hope still left out there, and there’s not, it’s all about collaboration and working together.  We saw this with shelving changing Medicare as it was still someone looking for glory the old fashioned way and it just does not work.   If you read the 2 links below I go into further detail on my thought here. 

Republicans Shelve Medicare Overhaul Plan–Lack of Business Intelligence, Technology And Behavioral Analytics Will Serve To Shelve Any Such Proposed Bill

Let’s get smart, use technology and work together and hang up the great white hope aspirations as it will sink every time from here on out as it’s not that kind of a world any longer and the stakes are too high not to use technology for better lawmaking and decision processes so let’s explore the public option and see if the law can be modified to allow the reform to continue, again as there’s a lot of good stuff in there we don’t want to change.  BD 

Digital Illiteracy Still Plaguing Lawmakers With Not Using High Powered Technology to Model and Simulate Healthcare Laws–Ryan Hasn’t Figured Out He’s No White Hope Yet (Video)

Press Release:

Docs 4 Patient Care, Benjamin Rush Society, and Pacific Research Institute
File Amicus Brief Against ObamaCare

Three Prominent Organizations Support Court's Decision that Obamacare is Unconstitutional

SAN FRANCISCO (May 13) -- Docs 4 Patient Care, the Benjamin Rush Society, and the Pacific Research Institute issued the following statements after filing an amicus brief in the U.S. Court of Appeals for the 11th Circuit supporting the district court's decision that ObamaCare is unconstitutional.
Hal Scherz, MD, FACS, FAAP, President and Founder of Docs 4 Patient Care said: "We believe that it is vitally important for a physician group to stand up and speak out on behalf of all of the doctors in this country who oppose this law, but feel disenfranchised and disheartened."
"As opposed to other medical organizations that have failed to stand up for its constituents and have instead urged them to accept the onerous changes being forced upon them by a statist administration, we are conveying hope by challenging the legality of this law and the brazen attempt of the government to control healthcare," he concluded.
Sally C. Pipes, founder of the Benjamin Rush Society and President and CEO of the Pacific Research Institute said: "We believe that the district court was correct that the mandates imposed by the federal government in the PPACA are not a constitutional exercise of governmental power. Forcing Americans to purchase expensive health insurance or face a penalty is not the responsibility of government. Doctors and patients -- not the government -- should be in charge. Only then will America achieve affordable, accessible, quality care for all."
Download a copy of the brief here.
###
About Docs 4 Patient Care
An organization of concerned physicians committed to the establishment of a health care system that preserves the sanctity of the doctor-patient relationship, promotes quality of care, supports affordable access to all Americans, and protects patients' freedom of choice. For more information, please visit www.docs4patientcare.org.
About Benjamin Rush Society
The Benjamin Rush Society aims to unite those across the political spectrum who believe that the profession of medicine calls its practitioners to serve their patients, rather than the government. For more information, please visit www.benjaminrushsociety.org.
About Pacific Research Institute
For 32 years, the Pacific Research Institute (PRI) has championed freedom, opportunity, and individual responsibility through free-market policy solutions. PRI is a non-profit, non-partisan organization. For more information, please visit our web site at www.pacificresearch.org.

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Extormity Releases Personal Ad Supported EHR–Maximally Invasive-Tapping New Sources of Revenue for Cash Strapped Doctors

5/13/2011 10:48:00 AM  ,  

Well we have all heard of ad supported so now we have personal ad supported software:)  As far as being certified, the company said we’re not worried about that as it’s all about our revenue and match making for patients, it can make us social again.  BD 

Electronic health record vendor Extormity today announced the launch of "Maximally Invasive", an electronic health record system supported by personal ads. "Max represents a significant departure from our traditional client-server EHR designed to siphon practice revenues directly from customers," stated Extormity CEO Brantley Whittington.

"Since we have driven so many cash-strapped physicians into the arms of acquisition-hungry hospitals, we decided to launch an EHR that taps a new revenue stream."image

Dr. Alan Kincaid, a family physician in Omaha, is an early adopter and fan of Max. "While ordering a CBC and a lipid panel, I simultaneously found a SWF AL SD who is into FTA - I'm not sure what that means but we are meeting for coffee next week," says Kincaid. "In just 8 hours, I used my new Extormity EHR to chart three physicals and a case of strep throat, and I used the ad module to find a handyman who does drywall repair, locate a remanufactured carburetor for a Porsche I'm restoring and purchase a first pressing of The Beatles Revolver album."

Maximally Invasive also enables clinicians to see context specific ads that benefit patients as encounters are documented. "I was able set up a date for one of our patients at-risk for diabetes with a fitness instructor who described himself as hot, healthy and into grueling workouts," added Kincaid. "According to my Extormity sales rep, this qualifies my practice as a medical home. The only real problem I have noticed is that the e-prescribing module defaults to a scrip for medical marijuana from a distributor in San Francisco."

image

Extormity CEO Whittington vigorously defended Maximally Invasive when asked if the presence of advertising in the EHR might be distracting to clinicians. "Our labor intensive EHR turns cognitive thinkers into clerical functionaries. As ads pop up frequently, it gives physicians something interesting to read while typing instead of listening to boring patients incessantly drone on about health problems." When also asked if Maximally Invasive will be ONC-ATCB and CCHIT certified, he expressed surprise, saying, "This is about our earnings and ad revenues, not the alphabet."

About Extormity
Extormity is an electronic health records mega-corporation dedicated to offering highly proprietary, difficult to customize and prohibitively expensive healthcare IT solutions. Our flagship product, the Extormity EMR Software Suite, was recently voted “Most Complex” by readers of a leading healthcare industry publication. Learn more at www.extormity.com

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Boston Scientific & Johnson and Johnson Still Spending Millions in Court With Stent Wars So We Can Pay For Properly Patented Devices That Hopefully We Can Afford

5/11/2011 03:51:00 PM  , ,  

Does this not get old when everyone is trying to save money in healthcare in every which area?  .  Well one of the 2 companies is getting a new CEO but it’s not Johnson and Johnson. 

Consumers lose as all this gets built into the price.

Will the “Stent Wars” Ever End – We Want to Be Able to Afford them Boston Scientific Files Cross Appeal
Where’s Some of the Focus for Johnson and Johnson Revenue Cycles – “Legally Patented Stent Wars”?

Boston Scientific (NYSE:BSX) took a time-out from the tsuris over CEO Ray Elliott's resignation to crow over a $19.5 million jury award in one of its stent wars with Johnson & Johnson's (NYSE:JNJ) Cordis Corp.

The case is one of two before Judge Susan Robinson of the U.S. District Court for Delaware, who ruled that separate juries would consider the penalty phases back in 2009.

Cordis won its June 2005 lawsuit against Boston Scientific, which accused the Natick, Mass.-based stent pioneer of infringing two of its patents (known as the "Palmaz '762" and "Gray '406" patents) with its Express, Taxus Express and Liberté stents.

Boston Scientific logs a win in stent war with J&J's Cordis | MassDevice - Medical Device Industry News

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Dr. Halamka Becomes Harvard Professor -How Can We Clone His Expertise As A Role Model

5/11/2011 02:23:00 PM  , ,  

Congratulations and I felt it was important to focus on the #2 item on his list, being a role model, and we have very few of these in consumer health IT and being a computer geek, a doctor and a consumer he does it all.  If you read his posts on his imageblog, you see it with examples of him being both in the physician spot and then he changes hats and becomes a patient/consumer too.  Hardly anyone else does that out there and that’s what we need, role models with ethics.  I read a lot of articles and reports when I do this blog and other than Dr. Halamka, I see very little and so many are still stuck on the paradigm of “its for those guys over there”.  We all know what that’s all about. 

“*Serving as role model - a strong sense of ethics and equanimity, always being moral and fair in every conversation and relationship, fosters an environment that encourages people to excel.”

If just some of those would practice and talk about what they preach, we would need a few less reports as I always say there’s nothing like “hands on” experience and just to correlate this, would you rather learn to drive a car from someone who currently drives on or one who has never driven a car but read a book and wants to tell you about it?  I don’t know of of too many that would value the 2nd response over the first:)  The second response though is so much of what we get today with consumer health IT, along with studies that continuously focus on how “stupid” we are as consumers all the time. 

New Report on Engaging Patients–Still Misses the Boat With Failure to Create Value for Consumers - “Magpie Healthcare” Paradigms

Sadly this is more of what we see at the link below with a Congressman from California totally disregarding cell phone safety and had to do an interview on his cell phone while driving and gets pulled over and embarrassed I might guess as the listeners get to hear it all.  Role model – fail here for the Congressman. 

US Congressional Representative Gets Pulled Over for Using a Cell Phone While Driving And Was Live on the Air Doing Radio Interview

You can read his entire post at the link below, as it’s a good one and again wish we could clone him a few times over and good mention too on his collaboration and building teams as in health IT we can certain use all of that we can get!   Congratulations!  BD

Today, I joined several friends and colleagues to celebrate my becoming a Harvard Professor.
Along the journey, I've learned many lessons.   Professorship is not about fame, fortune,  or what I know.  It's about community.   Early in my Harvard career, Dr. Tom Delbanco, Sam Fleming, Warren McFarlan, Marvin Schorr,  and others advised me to focus on creating teams of smart people to change the world.    

*Communicating ideas - publishing, lecturing, meeting, blogging, and serving on expert panels ensures that ideas and innovation are widely disseminated.   Today's blog is my 900th post, creating  a permanent record of the key ideas I encounter in my life as a healthcare CIO.

*Building teams - assembling and resourcing the best people, especially those with differing opinions and experiences, leads to innovation.

Life as a Healthcare CIO: On Becoming a Harvard Professor

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Germany Shuts Down Stem Cell Therapy Clinics–XCell Centers

5/11/2011 01:57:00 PM  ,  

Germany is also considering criminal charges from the results of two cases where the treatments did not go right, which included a death of an 18 month old boy who imagedied after stem cells were injected into his brain and another 10 year boy who was left severely disabled.  We always think of stem cell treatments being safe but when it comes to around the brain, that’s a while different concern.  If you go to the site, this is what you now see below.  BD  

“Due to a new development in German law, stem cell therapy is currently not possible to perform at the XCell-Center. Regretfully for this reason, we must cancel your appointment until further notice. We will notify you for further updates about the matter. For us to keep you updated then please fill in the form below”

BERLIN, May 10 (UPI) -- German authorities say they've closed down a controversial clinic offering unproven stem cell treatments for a variety of physical conditions.

The XCell clinic had been treating disorders including cerebral palsy, Parkinson's disease and spinal cord injury, ScienceMag.org reported Tuesday.

The clinic had been operating under a loophole in European regulations that allowed some treatments already in use when new regulations regarding stem cell procedures took effect to continue for 18 months without formal approval.

Germany shuts down stem cell clinic - UPI.com

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More “Stinking” Recalls From Johnson and Johnson–Treat The Pallets Outside & Solve this Low Tech Problem–Prezista This Time

5/11/2011 01:36:00 PM  ,  

This is beyond me as to why we can’t solve the simple part of the recalls for drugs and products that stink.  This is not a matter of technology here, it’s doing the work outside.  Again I have commented on this before and spent about 25 years in logistics and use to see it all the time, work moves indoors when the weather is bad or they don’t wait until the chemical dries.  Years ago I used to call on both Johnson and Johnson and Pfizer locations.  If the the weather is good, no problem.

image

Recall of Tylenol Expands on Adult Products – Smelly Chemical Issue – Bar Coding with Tags Really Needed To Alleviate Confusion and Problems Finding Products

When are they going to start bar coding for recalls!  This is ridiculous and it’s not easy to always find the product.  This is one more big fail for Johnson and Johnson and the FDA too.  Last week I wrote about the FDA luddites on this and you can read more relative to the big Triad recall, the “world classed outsourced manufacturing company for Fortune 25 companies” as stated on their web site.  With the surmounting number of recalls I’ll seem to see is Fortune 25 recalls growing and the “world classed”  part of this seems to be slipping away:)  BD  

Recalls: FDA Gets the Big Luddite Award with Drug and Device Companies That Do Little or Nothing to Help Consumers-Triad Products Could Have Been Bar Coded To Scan

Why? Johnson & Johnson points to trace amounts of TBA found in bottles sourced from a common supplier (see the statement). The chemical, known formally as 2,4,6 tribromoanisole, is used in wooden pallets that transport and store packaging materials. The problem has plagued J&J and Pfizer for some time (see here, here, here and here).

Why? Johnson & Johnson points to trace amounts of TBA found in bottles sourced from a common supplier (see the statement). The chemical, known formally as 2,4,6 tribromoanisole, is used in wooden pallets that transport and store packaging materials. The problem has plagued J&J and Pfizer for some time (see here, here, here and here).

What’s That Smell? Another Johnson & Johnson Recall // Pharmalot

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Bed Bugs Found Carrying Drug-Resistant MRSA– CDC Journal Study In Canada

5/11/2011 12:31:00 PM  ,  

The study information was released and performed in Canada but now we have a real reason to fear bed bugs as if it is happening in Canada and associated with 3 imagepatients, what’s the likelihood of it spreading?  The areas where the patients lived were impoverished area of the city and thus the amount of bed bugs in the community was higher than would perhaps be expected in other areas.  All it takes though is for one bed bug to travel and we know that story as bed bugs have been in the new a lot lately.  The pdf link to the document can be found here and thanks to the folks over at Wired for finding this. 

Back in July of 2010 a hospital went under lock down and was immediately fumigated with the ER room being where the bed bugs were found that came in with an ambulance.   A couple years ago a Fox news employee sued over bed bugs being found in the office. 

Bed Bug Found at Hospital Leads to Lock Down and Fumigation of ER Exam Room – One Bug

This is puts a whole new focus on bed bugs for sure.  BD 

In the June issue of the CDC journal Emerging Infectious Diseases, Christopher F. Lowe of the University of Toronto and Marc G. Romney of the University of British Columbia relay an observation they have made about bedbugs being carried by three patients who live on Vancouver’s Downtown Eastside — a neighborhood they describe as “an impoverished community in Vancouver with high rates of homelessness, poverty, HIV/AIDS, and injection drug use.”

The authors point out that several research groups have tried in the past to link bedbugs and disease transmission (of hepatitis, for instance) and have failed. They certainly have not proven transmission in this case. But they also say that there is a density of these two organisms in the area where the men live that make it more likely that bedbugs could be involved in diseases pingponging through the neighborhood. First, there’s the high density of bedbug presence, in 31 percent of Downtown Eastside residents. Second, there’s the high prevalence of MRSA, in 58 percent of the skin infections in the St. Paul’s ER. And third, there’s the previously recorded and persistent presence of VRE in in-patients at St. Paul’s.

Drug-resistant bacteria in bedbugs | Wired Science | Wired.com

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Is An X Prize Competition Methodology A Solution to Inspire Innovation in Healthcare Today? One More On the Way for A Tricorder

5/11/2011 08:10:00 AM  , ,  

Qualcomm based in San Diego has been working with the X Prize Foundation and the biggest part of the challenge here is to create the rules.  We live in a very complex and complicated society where “algorithms” and formulas have entered into almost any area of business, our personal lives and so imageforth.  Maybe competition of this fashion needs a make over.  When you look at the project wanting a device that can diagnose patients better than or equal to a panel of physicians, what’s up with that?  Is is a dream or is it capable of doing without violating a patent somewhere along the line?

Furthermore, who’s technology can those who enter use or does this need to be created from scratch totally?  The reason I mention this fact is that in software today as a comparison, we are very modular and do I or anyone else out there start from scratch anymore, heck no.  In addition we have technology coming out our ears in healthcare and some of it is a bit strange in nature and of course a device of such would have to have full audit trails and be HIPAA compliant along with a bunch of other requirements too.  Is there anyone or small companies out there who would have the money to hang in there with all of this? The prize is $10 million and you wonder if the development and research would go beyond what the prize money would offer.  You can ask a few biotech companies and Health IT companies perhaps that have bit the bullet with some of their efforts. 

We all remember the last one by WellPoint on the X Prize offering $10 Million for a solution to solve our country’s healthcare issues.  It died and of course there’s no solution on solving our issue out there yet as it requires laws, technology, collaboration and so forth, so in essence it didn’t work.  The initial offering on that X Prize was created in April of 2009 and kind of died a slow death I think.  The puzzle of solving healthcare is the US is a bigger and more difficult nightmare than ever. 

X PRIZE Foundation for HealthCare – Is the Incentive High Enough

At the same time as the X Prize was announced for Healthcare, a very successful retired MD in Los Angeles put out a prize of $75 million for groups to come up with a non surgical way to sterilize cats and dogs.  The rules here are specific and the program is on the way with many groups working on the project and the reward is about $65 million more than the WellPoint offering.  Dr. Michelson was quoted in stating that $10 million was not enough for his project. 

$75 Million to Sterilize Pets With A Non Surgical Procedure - $10 Million to Build a Better Health Care System in the US

In addition I am guessing the X Prize for genomics is still alive and well but the face of technology and cost of sequencing by commercial companies is kind of leading the way here as well, so we have the Polonator from George Church who entered which is now old technology and we have semi conductor desk top gene machines out there today.  So it does make you wonder about the methodologies used here for such a prize?  Does it still work? 

Genomics – Who’ going to win the X Prize?

Some of the earlier challenges were met through the program but again with current day technologies bursting out at the seams all over today, can this effectively be conducted without perhaps a string of legal cases?  The article here states it’s going to take 6 months to create the rules and with the way technology moves today, those could stand to be amended the day they are released.  We have companies today with algorithmic formulas that can change business models in 48 hours or less, role out the new structure and begin closing plants and shifting people around or laying off and we see it all the time in the news.  We don’t have a Congress that can respond to this and we all know how long it takes to create a law so perhaps with creating the rules for this contest they might be sharing some of the same complexities as lawmakers.  Just recently the President released an executive order for all federal agencies to submit their plans to improve customer service and their use of technology within 6 months.

President Obama Issues Executive Order To Federal Agencies to Improve Customer Service And Use Technology To Accomplish

This really get interesting with being pulled in both directions here with technology as when you look at the other side, we have Senators who voted down funding cloud technology too, so digital illiteracy at work there for sure and this just shows the various levels people are at with working with and using technology for a comparison and why things get so confused and misinterpreted today.

Senate Cuts Cloud Services From Budget That Would Allow for Data Center and IT Infrastructure Consolidation–Back to the 8 Track Tapes Next?

It will be interesting as this moves along to see how complicated the rules get and if they are open enough to where someone can actually compete and stay within the parameters set forth.  I just see collaboration as a better way of doing things and perhaps the days of hanging out carrots for such complicated competition efforts could be numbered.  There’s another such project out there backed by Heritage and former HHS director Mike Leavitt on a $3 million dollar competition to find the “code” and/or “algorithms” to figure out re-admissions for hospitals and I wonder about the clarity on that as well.  I used to write code and know how to query and create the stuff and you still have the humans at the end who “interpret” all of the information and how they use it and in today’s world we see both use and misuse all the time.

Heritage Providers Continues to Promote $3 Million Dollar Prize to Create An Algorithm To Predict and Prevent Hospitalizations

By the way as a footnote, Dr. Michelson mentioned above with his competition for cats and dogs won a huge lawsuit years ago against Medtronic for patent infringement for several of his surgical devices he created, so again when you put this in perspective of “prize” offerings and today’s complexities, can this methodology still work and how much are those algorithms worth that create solutions today that hopefully don’t infringe on anyone else's territory worth?  BD

Qualcomm (NASDAQ: QCOM) chairman and CEO Paul Jacobs revealed today that the San Diego-based wireless technology giant has been working with the X Prize Foundation to develop criteria for a new $10 million X Prize grand challenge that is straight out of Star Trek—a “Tricorder X Prize.”

The idea—which is still being distilled—is to offer a $10 million incentive prize to the team that can develop the first diagnostic device that actually works like the ubiquitous medical tricorder of Star Trek fame. Generally speaking, the technology would have to be portable, use wireless sensors, be minimally invasive, and capable of providing rapid, low-cost diagnoses of medical ailments and injuries. Oh, and organizers also want the gadget to be able to diagnose patients better than or equal to a panel of board-certified physicians.

For now, however, the more immediate challenge lies in establishing the ground rules for a fair competition.

“It’s got to be really difficult, but not impossible,” said Ching. She estimated that developing guidelines for the Tricorder X Prize would take about six months—a process that Qualcomm is funding—and the foundation would likely formally announce the challenge sometime next year

Qualcomm and the X Prize Foundation Move to Energize Diagnostics with $10M ‘Tricorder Prize’ | Xconomy

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Strange Social Networking Device for Smokers–E-Cigarette in “Smart Packs”

5/10/2011 11:52:00 PM  ,  

I have seen and heard just about everything electronic that wants to communicate imagenow. I guess you can call this the “revenge of the vices” for devices.  It will also tether to a cell phone in later versions.  When an individual walks by where the Blu packages are sold the pack vibrates and it also serves as a charging unit. 

The part about connecting to a smart phone and reporting back to a doctor is interesting but I guess it could be useful for someone who is stopping?  I’m not exactly sure how that would work.  It is also supposed to buzz when someone else who has a unit is close by. 

I don’t know anything about the e-cigarettes as far as if they cause any harm or not but I guess they are acceptable indoors as there’ no smoke. We all know everyone is on the location kick to let everyone know where you are and I guess the social part is bringing together others who have pack but it costs $80 with 5 e-cigarettes inside.  I can’t figure this one out as one’s cell phone does that and it’s an extra cost to have a wireless pack.  This is one for strange and beyond and they say only 1 out of 100 wireless devices make it and I’m not putting any money on this one:)  BD

Companies have started adding the ability to communicate wirelessly to an increasing range of devices, like tablet computers, cars and refrigerators.

Blu, the maker of electronic cigarettes that release a nicotine-laden vapor instead of smoke, has developed packs of e-cigarettes with sensors that will let users know when other e-smokers are nearby.

E-cigarettes have several obvious advantages to their traditional counterparts. They allow users to avoid bans on smoking in public places because they release only water vapor. Mr. Healy and other e-cigarette manufacturers also claim that they have practically no negative health effects — an assertion that draws skepticism in many quarters. But the devices are also, in their own way, gadgets.

The packs also conveniently vibrate when a smoker nears a retail outlet that sells Blu cigarettes.

Later versions will be tethered to a smartphone through an app, allowing more options for real-time communication, Mr. Healy said. The company also plans to develop a system through which the packs will monitor how much people are smoking and report back to them — or to their doctors.

Mr. Healy says he thinks the connected packs would be most useful in nightclubs, where people are interested in striking up conversations and want to smoke without being forced outside.

Blu Develops a Social Networking Device for Smokers - NYTimes.com

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Human Genome Project: How A 23 Chromosomes Made An $800 Billion Economic Impact

5/10/2011 10:51:00 PM  ,  

As the article states we are just getting started as genomic information is being used in more areas than just healthcare, such as Law enforcement.  Last year imagegenetic research generated $67 Billion.  Drugs are now able to target patients with specific genetic qualities, aka personalized medicine.  I have been doing this blog for about 4 years now and when I go back and look at what I was writing then, it has changed tremendously in such a short time.  Back in 2008 George Church had his Polonator DNA Machine which looked like this.  BD 

The Polonator - the DNA Machine for $150,000

According to the report, the nascent genetic research industry generated $67 billion in U.S. economic output and created 310,000 jobs in 2010 alone. "We were surprised by just how large the economic impact had been," says Greg Lucier, CEO of Life Technologies (the foundation that sponsored Battelle's research). "What was even more interesting for me is that we're just getting going. The ability now to read genes quickly and economically is opening up entirely new vistas of opportunity."

And that nearly $800 billion is just the start of the money that will start rolling in as technology improves. "In my view, DNA sequencing will become as ubiquitous as the stethoscope in medicine," says Lucier. This could happen sooner rather than later; the same sequencing services that cost billions of dollars 10 years ago cost only thousands of dollars today.

The Human Genome Project: How 23 Chromosomes Made An $800 Billion Economic Impact | Fast Company

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FDA Requesting Most all Manufacturers of Hip Replacements To Begin Studies On Failure Rates

5/10/2011 09:44:00 PM  ,  

The point of the study is to find out how fast and how many will fail, what is the imagefailure rate.  We have Johnson and Johnson largely at the head of this investigation for their DePuy failure rates and recalls, and of course they no longer make the product.  As you can see below at the bottom there are others named in the request and there could be more requests generated as the FDA may look into the entire area of implants before they are done.  BD 

In an unusual move, the Food and Drug Administration has ordered all producers of a popular category of artificial hip to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients.

In a telephone interview on Tuesday, Dr. William H. Maisel, the deputy director for science at the F.D.A.’s Center for Devices and Radiological Health, said the order marks the broadest use of the agency’s authority to conduct studies of devices after approval for sale. He also said that the F.D.A. wanted information about the entire category of implants, not any single manufacturer’s device.

“This is the largest group of studies that we have asked for,” for an approved class of devices, said Dr. Maisel.

Along with the DePuy division of Johnson & Johnson, other major producers of hip implants include Zimmer, Stryker, Biomet and Wright Medical.

Studies Ordered for Makers of Artificial Hips - NYTimes.com

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President Obama Will Soon Have the Ability to Send A Text Message to Any Cellphone in the US–PLAN

5/10/2011 09:06:00 PM  , ,  

This is good and other agencies such as FEMA and Homeland Security will also be enabled and New York is the first place for the trial.  New phones will require users to make a choice on whether or not they want to received alerts but the only one that can’t be blocked is the President.  He’s has had one busy week and add some new technology news in as well.  Nobody needs to sign up as it will be automatic in the phone. Amber alerts will also go out in this fashion, and that’s a good thing too.

PLAN is the name of the emergency alert program.  The rest of the country should be online by the middle of next year.  PLAN stands for Personal Localized Alerting Network.  BD

President Obama, who has been called the texter-in-chief, will soon imagehave the ability to send any cellphone in the U.S. a text-message warning of impending danger, from a tornado to a terrorist, under a new emergency alert system called PLAN.

The new system, which was announced Monday, is an expansion of the Federal Communications Commission's emergency alert system, which is currently broadcast over radio and television.

PLAN, which is short for Personal Localized Alerting Network, will first be rolled out in New York City by the end of 2011, with the rest of the U.S. to follow in about the middle of next year, the FCC said in a statement.

President Obama could send text-message warnings under new PLAN system | Technology | Los Angeles Times

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New Law In Florida Passed by Legislature Bans Doctors From Asking Patients If They Have Guns in Their Home

5/10/2011 06:04:00 PM  ,  

I can’t remember the last time a doctor ever asked me this, in fact I don’t a doctor ever did!  Obviously this might be more prevalent in the areas of psychology or counseling as when I go in for a physical it’s not one of the normal subjects that comes up.  I have never had a doctor talk to me about gun safety.image

There had to be some case somewhere along the line that created a stir to bring this to the attention of the legislature to create a law.  It doesn’t make sense to spend time on a bill like this.  So if you are a doctor don’t even mention the word gun I guess and if you are a patient don’t mention them either so as not to accidentally get your doctor into a conversation about guns if you like in Florida. 

How’s anyone going to enforce this and what are the real parameters!  This looks like a big waste of time somewhere along the line when we have more important issues at hand.  BD

Doctors will be banned from asking patients whether there are guns in the home, under legislation expected to be signed into law by Florida Gov. Rick Scott. 
Whether a person has guns in the house may not immediately sound like a medical or health-oriented question -- unless you count not dying as a health issue. Doctors, for example, can ask patients whether they have pools, so that they can counsel them on pool safety issues. That's an important service for some parents of young children: According to the Centers for Disease Control and Prevention, a third of all unintentional deaths of children between 1 and 4 years of age were due to drowning in 2007. People often don't realize what risks there are in their own households -- and guns at home do seem to fall into that category.

NRA-supported Florida law bans doctors from asking gun-related questions - latimes.com

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Recalls: FDA Gets the Big Luddite Award with Drug and Device Companies That Do Little or Nothing to Help Consumers-Triad Products Could Have Been Bar Coded To Scan

5/09/2011 06:40:00 PM  , ,  

Read the quoted paragraph below, a veteran gets a notice 3 months after the recall, imagewell gee….bar codes would have made this information available immediately.  The world class factory still remains closed after the FDA moved in.  I did a poll and consumers want this and would use it, but nobody cares about serving the consumer, they just want their money and are acting like a BP with no disaster preparedness. 

One thing though is that they can sure put out a lot of useless consumer mobile software that nobody uses and some of the drug companies are retiring a lot of what they bothered with.  J and J has done nothing for consumers either with all their recalls. 

“At least one veteran, however, said he’s been using alcohol prep pads supplied by the VA for three years, and that officials only warned him to stop in a form letter included in a medical kit dated April 7, three months after the initial recall was issued.

Is a Non Technical FDA Recall System Like Another BP Oil Spill Waiting to Happen One Day

I have written to the FDA on this as well as drug and device companies and nothing but buy that product and bring in that money.  I wrote a post about how it took me 2 weeks to get a canned response that most web sites send immediately.  The White House even does that.  Heck when you give the FDA the input they ask for I don’t think they know what to do with it or even if they read it. 

FDA Looking for Public Input on How They Communicate With the Public-In My Case They Don’t Relative to Using Bar Codes for Device, Drug and OTC Products Recalls

By the way the President sent an executive order out asking what federal agencies are planning to improve customer service with using technology and do you they might fit this on their list…would be a good idea.

President Obama Issues Executive Order To Federal Agencies to Improve Customer Service And Use Technology To Accomplish

FDA Moves in on Triad and Seizes $6 Million Dollars of Product-The Medicated Wipe Recalls Issues Continue - Triad is an Outsource for Several Fortune 25 Companies

FDA Announces Recall of Alcohol Prep Pads, Swabs, Swabsticks From Triad–FDA and Manufacturers Should Ashamed-Campaign for Bar Codes Still Stands Stronger Than Ever!

This is by far the biggest neglect of both the FDA and drug/medical device and over the counter healthcare products!!  Have you ever tried to return a product to a retail drug store and be told “no” because it’s not on their authorized list!!  Now some of their products are used by healthcare professionals too and I looked all over the web site and as close as I could come was to find wipes or products that remove adhesive tape so I think this is what the product recall is all about that could be contaminated.  A cell phone to scan the box would soooooo simple.  image

This is another good sized recall and granted the products are not expensive but for goodness sakes we have private label stuff in here now too.  If in fact the products are not sanitary we need to have an easier way to find them on the shelves.  Look what a mess they make for the retail stores too. 

CVS and Walgreens should join my cause here as this is just simply “tech denial” and nobody wanting to do a thing about it.  I have sent this to drug companies, the FDA, the DEA and several other deaf ears. This is costing the retail stores money too!  Again, a good reason for them to join the cause here.

I just did a post this morning about a company that uses bar codes to help us determine what nutritional values sit on the grocery shelves so everyone wants us to eat right but if something is recalled, go ahead and get sick and die is the message I am hearing.  The same thing with Walgreens, only efforts go out that generate money and nothing for consumer safety and information and pick up some data for sale on you when you use the bar code. 

Walgreens Releases Windows 7 Application Using Bar Code Technology To Order Prescription Refills

All involved need to collaborate here and fix this and get those bar codes out to help consumers.  My little campaign is getting close to 2 years old now and has permanent links at the top of the page. BD 

A quarter of the nation’s Veterans Health Administration medical centers and the agency's outpatient mail-order pharmacy used recalled alcohol prep pads and other products blamed in lawsuits for infections and a death, msnbc.com has learned, prompting a new round of concerns from a U.S. senator.

Bennet, along with Sen. Lamar Alexander, R-Tenn., had previously questioned the federal Food and Drug Administration’s handling of problems with contamination and sterilization at the Wisconsin plant. Those issues eventually led to the recall of hundreds of millions of products used in hospitals, clinics and homes and widely sold in grocery and drug stores.

Thirty-eight of the country’s 152 major veterans medical centers in 30 states and the District of Columbia removed recalled wipes, pads and other products from use, VA officials told msnbc.com. See the box below for a complete list. In addition, the products were removed from the Consolidated Mail Outpatient Pharmacy, which provides more than 97.4 million prescriptions a year to veterans.

The original recall has expanded 40 times since it was issued in January, Hammonds wrote, as Triad Group products were detected in other products such as suture kits that involved additional brand names.

Suspect wipes used at VA medical centers - Health - Infectious diseases - msnbc.com

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