Erbitux has been approved since 2004 to treat colorectal cancer for late stage cancer after chemotherapy treatments had ended. The drug sends a signal to stop the growth of tumors in short. When a KRAS gene mutation is found, the tumors continue to grow so with finding this mutation it gives additional information on whether or not the patient should be on the medication or whether the treatment would not do any good.
The FDA also approved the use of the drug in combination with Folfiri chemotherapy drugs as a first line treatment for patients with metastic tumors with CRC . BD
The U.S. Food and Drug Administration today approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the absence of a gene mutation.
The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in patients whose CRC has spread to other parts of their body (metastasized).
Studies have found that Eribitux is not effective in those who have the mutation.
CRC is the third leading cause of cancer death in the United States. According to the American Cancer Society, there were more than 141,000 new CRC cases in 2011, and nearly 50,000 deaths resulted from CRC.
Among patients with tumors that did not have one of the seven KRAS mutations, median survival was 23.5 months for those who received Erbitux plus FOLFIRI compared with 19.5 months for those who received FOLFIRI. Among patients whose tumors had a KRAS mutation, median survival was similar between those who received Erbitux compared with those who did not.
This does make the Celltex case in Texas come back to light again as a few weeks ago it was all over the news. These were all non substantiated stem cell treatments to where fat cells were taken, shipped to Korea and then returned. Perhaps the FDA has another upcoming inspection? As this article points out though lawyers know a good lawsuit when they see one. Any MD who is participating in non substantiated stem cell procedures today is walking on thin ice. We do hear so many claims about stem cells and sometimes folks can’t tell the difference especially when any of their other treatments have not worked prior.
The treatments all took place in China or Tijuana and at the Mexico location, 5 of the patients developed infections after their injections, not good. RNL Bio is the parent company of Human Biostar. Back to the Texas case, who was Celltex doing business with, RNL Bio. BD
In what could be a landmark case, six patients in California are suing one of the world’s largest stem-cell companies for allegedly misleading them about the effectiveness of its stem-cell treatments.
The six patients all live in Los Angeles or Orange County and share the last name Lee. Some of them are related, according to their lawyer, the unrelated Sang I Lee. They are suing Human Biostar based in Sugar Land, Texas; Jin Han Hong, the company’s chief operating officer; and Jeong Chan Ra, a Korean citizen and chairman of the board of Seoul-based RNL Bio, the parent company of Human Biostar.
The six patients claim they were sold the procedures by Hong when he was president RNL Life Science, another subsidiary of RNL Bio, based in Los Angeles. The procedure consists of taking fat from a patient, removing stem cells from the sample, processing and expanding them in RNL’s Seoul laboratory, and then sending them to one of RNL’s clinics to inject them into patients to treat a variety of diseases.
The case could bring closer scrutiny to stem-cell treatments throughout the United States. Until now, clinics advertising or selling unproven and unapproved stem cell treatments to patients had to worry only about the FDA, which monitors the clinical use of stem cells to ensure safety and efficacy — but moves slowly and bureaucratically.
My first comment here is that’s a lot of money. The company is located in Canada and works with doctors and surgeons to develop devices in the area of DVT prevention and vascular solutions as well as wound healing and pain management. Check these 2 products out as I have not seen anything like them out there. The Venowave seems to work by improving circulation and attaches to the back of your leg and the IceOtherm gives feelings of sensation to relieve pain. Again, this is still a lot of money. BD
From the website:
“The Venowave VW5 is a medical device that has been statistically proven to prevent a DVT from occurring, in at risk patients. Traditionally, compression stockings and anti-coagulants (blood thinners) have been the gold standard in DVT prevention until today. The Venowave VW5 can be used alone or in conjunction with blood thinners and/or compression stockings.
The Venowave VW5 is applied to the back of the calf and mimics the body's venous system preventing blood from remaining still and clotting. The Venowave VW5 is unique because it is lightweight (250g, less then ½ pound), discreet and allows patients to remain completely mobile. There are no wires, tubes or sleeves. The Venowave VW5 can be used in hospital or during homecare after discharge from the hospital”.
“The IceOtherm is a class II medical device designed to engage the body’s natural healing abilities using both hot and cold stimuli. The interlaced hot and cold stimuli, induces a paradoxical burning sensation known as the Thermal Grill Illusion. The Thermal Grill Illusion has been known to scientists for over a century, and was developed and first studied extensively by Thunberg in 1896. In scientific research applications, the thermal grill is used to create harmless sensations of pain.”
Saringer Life Science Technologies Inc. (SLST Inc.) is seeking a major investment in order to expand their medical technology company. Business experts claim that this is one of the biggest and most lucrative propositions in Saringer’s history and that the company shows an enormous potential for return.
The Venowave VW5 and the ICE-O-therm. After years of clinical studies and product testing, both products use the latest state of the art technology (IP protected) and are ready to be commercialized. The products have a broad range of approved indications including pain treatment, preventing blood clotting or Deep Vein Thrombosis (DVT), and a broad range of vascular conditions including the most severe; Post Thrombotic Syndrome (PTS). Most recently scientists are studying the Venowave and its ability to heal chronic diabetic foot sores after an impressive case study was conducted with a 100% success rate. Many of these conditions are largely unmet clinical needs and alternative treatments are scarce.
“We’re definitely on the verge of reaching one of our biggest milestones yet,” exclaims Saringer. Although the majority of investor dollars will go towards expansion and revenue generating initiatives, some will also go towards Saringer’s most recent focus: how the Venowave VW5- a sequential compression pump that attaches to the back of the calf in order to increase circulation - can heal diabetic foot ulcers. “It’s time to take things to the next level and find a cure for chronic diabetic foot ulcers.”
No you can’t go there yet as this is being built for intelligence agencies by Raytheon. the government gets it first. It picks up everything from a news item and finds the relationships between the data and information. It still doesn’t get everything right but getting closer. This sounds a bit like what we are doing in healthcare with non structured data, doesn’t it? BD
They look a bit like communally written Wikipedia pages. But these articles—concise profiles of people and organizations, complete with lists of connected organizations, people, and events—were in fact written by computers, in a new bid by the Pentagon to build machines that can follow global news events and provide intelligence analysts with useful summaries in close to real time.
The prototype system is part of a nonpublic site built for intelligence agencies by Raytheon BBN in Cambridge, Massachusetts, and scheduled for delivery to the government later this year. It gathers information from 40 news websites written in English, Chinese, and Arabic, and eventually it will cover hundreds of news sites in all major languages. Ultimately the system will be linked with an existing TV broadcast monitoring network.
Automatically summarizing text is notoriously tricky given the difficulty of detecting humor, sarcasm, obviously incorrect information, idioms, and variant spellings and syntax, not to mention the problems involved in interpreting and translating information sources in different languages.
Ok now that I have your attention, here’s the Watch Dog:) Actually over the 4th of July my little assistant is very sensitive to the noise and found a new place to hang out to escape. His place of choice was right on top of my hard drives and he had to crawl up a few shelves to get there. Anyway this was a little too cute to pass up. BD
As far as avoiding hardware theft, I don’t think I can get any better than this:) BD
What robot performs prostate cancer surgery, the daVinci and the device helps surgeons identify nerves that may otherwise not be visible. If you read the news there have been a few incidents reported with the robot, I have not seen a lot but there are some. The device consists of a Pep monitor, a control switch and an electrode kit. The kit is a single use disposable unit. The electrode connects to the monitor. This appears to make the procedure and the robot safer. BD
ProPep Surgical, a privately-held, Austin-based medical device company, announced today it has received FDA 510(k) clearance for its ProPep Nerve Monitoring System – a family of products that allows surgeons, for the first time ever, to do intraoperative nerve monitoring during minimally invasive, robotic-assisted surgery for prostate cancer.
The ProPep Nerve Monitoring System is the first real-time nerve monitoring system specifically designed for use during robotic-assisted radical prostatectomy, the most common treatment for prostate cancer. Fast, accurate and easy to use, the System gives the surgeon real-time feedback regarding the location and integrity of otherwise invisible nerves during robotic-assisted radical prostatectomy. “One of the biggest fears about prostate cancer surgery is the potential for nerve damage. To reduce the side effects associated with this nerve damage, the surgeon must do two things; spare the nerve tissue, and not damage the nerve tissue while sparing it,” according to Dr. Randy Fagin, Chief Medical Advisor.
“Currently, surgeons rely on anatomic landmarks to identify nerves during surgery but research has shown these landmarks are not always reliable and even if you successfully spare the nerve tissue, there has never been a way of knowing, in real-time, how much damage was done to the nerve while trying to sparing it.” The ProPep Nerve Monitoring System is the first product that provides the surgeon real-time information to not only make a more informed decision about which tissue to selectively preserve or remove during an operation, but to also assess the integrity of the nerve during the procedure. “This information has never been available before. Having it can change a surgeon’s decision making during an operation and could potentially reduce the incidence of nerve damage related side effects such as incontinence,” says Dr. Fagin.
Sales are down so buy some more drug stores? It certainly seems like this is what we are seeing out there. If we go back to the split with Express Scripts and the loss of revenue in prescriptions there, well that might shed some light on the size of the loss of revenue and maybe it’s bigger than anyone thought.
Along with the purchases comes another source of profit and that is more data potentially for sale which is becoming almost like oil these days and companies are making billions. On their 2010 SEC statement, Walgreens made just short of $800 million, selling data alone, so when you add up all these acquisitions, just think of how much data for sale they might be getting access too and what additional dollars that could mean. I keep saying we need to tax banks, companies, etc. that make billions of dollars from selling data as it has behind the scenes crept in to where it “is” part of doing business today.
They are spending $438 million on this purchase. The store has also been busy getting liquor licenses in the last year in stores where they have not sold it before to add to the number of products they carry.
In addition to all of the above, they are also expanding their efforts into social networking to send ads to your cell phone to for promotional sales and there were several news items in the last year speculating on whether or not the drug stores will start selling insurance too. Back a couple years ago they announced that they were working with Orbitz travel services too so that those booking travel through the company could also get coupons for discounts at the store, in other words promoting “travel healthy”.
In view of all of the above, one certainly can gather the impression that profits may not specifically be found in selling prescriptions, but rather in all the other entities that are combined efforts with what we are seeing out there with acquisitions and promotions. BD
Walgreen also said Thursday it will spend about $438 million to buy a 144-store chain focused on the mid-South from the privately held Stephen L. LaFrance Holdings Inc., which is based in Little Rock, Ark.
Stores in the chain include USA Drug, Super D Drug and May's Drug. They are located in Arkansas, Kansas, Mississippi and Missouri, among other states.
Just a few months ago India announced they were authorizing a local drug company to make a generic copy of a cancer drug made by Bayer. This opened a lot of eyes and Roche for one looked into their pricing on cancer drugs and is reducing prices on some of their drugs too. It appears the move is on to make drugs affordable.
Part of the response has been with big pharma buying generic drug companies. The new policy is slated to begin before the end of this year. This certainly is good news for patients in India who are in the poverty levels that have not been able to get treatment, especially with cancer drugs. BD
(Reuters) - India has put in place a $5.4 billion policy to provide free medicine to its people, a decision that could change the lives of hundreds of millions, but a ban on branded drugs stands to cut Big Pharma out of the windfall.
From city hospitals to tiny rural clinics, India's public doctors will soon be able to prescribe free generic drugs to all comers, vastly expanding access to medicine in a country where public spending on health was just $4.50 per person last year.
The plan was quietly adopted last year but not publicized. Initial funding has been allocated in recent weeks, officials said.
But the initiative would overhaul a system where healthcare is often a luxury and private clinics account for four times as much spending as state hospitals, despite 40 percent of the people living below the poverty line, or $1.25 a day or less.
Under various existing programs, around 250 million people, or less than a quarter of India's population, now receive free medicines, according to the health ministry. "If doctors are found to be prescribing medicines which are not on the list, or which are branded, then disciplinary action will be initiated," he said.
Here’s a clip from YouTube that is a small portion of the interview. It’s worth your while to go over and listen to the full interview when you can.
He talks quite a bit about India and China relative to technology and his opinion of where each excels etc. Sometime he says in the next 10 years we will be able to cut the existence of malaria. He also discusses HIV and how to attack the disease and what has been done thus far and says it will be a while before we really can reduce the numbers. Bill Gates was always a science fan and with his work with the Foundation he’s been able to expand his learning.
He talks a bit about software and it has evolved and gets around to talking tablets and pcs. Funny when he talks about Apple and Steve Jobs and admits they did something better than he did. He also says Microsoft has something with Surface that could change the rules again with fusing the pc and tablet worlds. He says competition among software companies is a positive thing and states he’s not starving, so Apple, Google Microsoft and others competing is good. Bill Gates still does get to suggest new project that Microsoft works on, but he would never go back full time.
On Facebook, he says “Steve bought” and does see it as having importance. In the end he says it’s all about the applications. Again a very good interview and the first half is more about the Foundation and the second half deal with his thoughts and comments on technology. He calls drugs and vaccines that are created but that are too expensive for people to afford a failure in referring to “markets”. Philanthropy is still very necessary.
Gates says there’s a real contrast between politics and science and he hopes it changes as that’s all that is generally is seen he says in the news and so forth and steels the focus. Politics slow down innovation he states. He hopes that some middle ground is found in politics and talks about the same disappointments that we all have. He should know as for many years he testified about better education in Congress and has faced many deaf ears. BD
This lawsuit should be interesting indeed as I’m sure there’s a little of both sides in here, relative to Aetna claiming over charging at surgical centers and then again there are those situations to where the Out of Network charges were in line but didn’t meet the Aetna Algorithms for quality and cost control. I think the over billing by facilities by facilities owned by doctors exists but in reality is probably a small portion of this entire case. Like everything there are those out there that find loopholes and milk it. Aetna is probably correct on a case by case basis on some of the billing that takes place with way beyond normal customary fees but again you can’t use this as a “whole” perception when you look at all of it. I read one example here about a kidney stone fragmentation questioned to where Aetna claims $7,612 should have been the appropriate charge and they were billed $73,536 and there’s certainly enough in between those two numbers to question.
It’s also again a case by case situation as we don’t have more information than the numbers quoted so what else was in the bill I think anyone would ask, were there complications, etc.? Obviously Aetna has some pressure here with first quarter results and answering to shareholders.
The link above is actually pretty interesting as there are a couple other links that describe some strange events. This one in particular is kind of odd…with patients being told their doctor is no longer in network, but yet was a mistake? Yup we come right back around to accounting and business intelligence algorithms here setting the stage.
I think they are having a hard time with some of this and granted there are some way out of whack charges that they should contest but when running analytics in some areas on percentage points, I think this is where we get down to some tit for tat issues. Doctors are graded in the Aetna system just like all other do and an MD maybe staying right within the suggested areas until it happens, one very sick patient who needs care outside of what the in network specialists can provide. That patient gets referred to a “specialist’s specialist” and none of those folks are on the “approved in network” lists anywhere for the most part. The patient goes and receives treatment and the big bill comes back and analytically even though it was approved, the “out of network” algorithm catches it, just looking at the amount of the bill.
In yet another area an analyst might see this and “flag” the doctor for going outside of the normal and customary charges without perhaps looking at the entire case, numbers “say”. So you do have this situation that arises and one sick patient skews the numbers the insurer states he/she should stay within.
I understand trying to keep costs in control and it’s not easy, but it requires skills that go beyond “grading on a curve” if you will and this just goes to further explain the needs for each case to be investigated on it’s own. This is a throw back to the HMOs when they first started here in California years ago. In Texas several doctors were removed from contract by Aetna and again it may have caught some over billing but how many were caught in the “one sick patient” scenario that created the situation for them to fall out of favor relative to cost control? Furthermore if the referral was initially approved and debated later, do we go back and look at what substantiated the referral in the first place?
One other item worth a mention too is that insurers are branching into other types of businesses as well, like Health IT with purchasing subsidiary companies. Here’s an example below of one of Aetna’s companies below that provides services to connect electronic records.
In August of this year folks in Colorado will no longer be able to purchase Individual Health insurance policies, so I am guessing they ran out of ideas and algorithms to keep this area profitable, but they will still continue to work with employer provided insurance plans.
With the complex medical billing system we have today this is probably not something that will go away any time soon as on the other side there are consultants who help the folks submitting claims to maximize their income so we have the battle of the algorithms for profit and cost duking it out once again. One doctor in New Jersey was so upset that he made a video about it and again I am assuming he might be one of those caught up in the “grading on the curve algorithm”, but again this shows how each case should be treated as it’s own to get to the bottom of why the doctor slipped out of grace with the insurer. BD
Aetna and the Doctor
(Reuters) - Thousands of doctors in California are suing the health insurance company Aetna Inc claiming the company routinely denies patients access to out-of-network doctors even when the patient has purchased a policy giving them the right to choose providers.
The lawsuit, filed in the Los Angeles County Superior Court, accuses Aetna of threatening patients with denial of coverage if their members visit doctors outside the Aetna network of providers, and of threatening doctors with having their Aetna contracts terminated if they refer patients outside the network.
By now you have probably read the news about the HIV test approved by the FDA and in case you missed it, you can read about it here. The OraQuick Home-Use HIV stick now has the approval of the FDA. It has been used in clinics for a while now and comes with some precise instructions on how to use the test. Technology doesn’t stop for a minute today and it seems as soon as a product is released that it’s not very long before a new product is around the corner and this is the story with LifeSaver Products. It’s great that the FDA is giving consumers an opportunity to test for the virus in the privacy of their own home.
In addition to HIV testing LifeSaver also has the same simple process available for drug and alcohol testing. Being that the FDA approved the HIV test I’m going to focus on this process first. If you have read any of the many announcements in the news today, then you can see there is a process to go through to ensure the test is done properly, swabbing for 2 minutes is the first item that you need to be sure to read, as otherwise the accuracy of the test could be compromised. In addition, there’s a bit of a waiting time for the results.
In addition to home testing, CDC (Center for Disease Control and Prevention) is also bringing the test to pharmacies and the program was announced last week to where pharmacists and retail store clinics to 24 sites. Counseling will be a big part of their training to guide consumers on where to go if they have a positive test and to discuss with their doctor. This is a pilot program to develop a tool kit for the clinics and pharmacies to implement testing at their locations.
Now that you have read the above and probably much of the other media that is out there about the FDA approved test, don’t you wish the test could possibly be a little simpler in nature? This is where LifeSaver comes in. Instead of swabbing for 2 minutes, a 2 second swipe for saliva on the tongue would be enough, so no worries about the amount of time to ensure you have enough saliva collected for the test. The website announced the creation of this simple technology last year. An image of the Stik below shows either a plus or a minus sign when the test has completed. If nothing appears, you could grab another stick and test again. This would show the test had been compromised but somewhat unlikely with normal handling procedures.
“Due to the protective properties of the patented packaging system and the proprietary formulation used by Ttest, antibody and enzyme-based tests can be protected in environments that may otherwise prove destructive to them. Ttest’s product stability and shelf life allow for accurate diagnostic tests in most places where onsite testing is done such as in clinics, the workplace, public areas, law enforcement situations and at home. “
Here’s a comparison of the two HIV testing products and you can make your own determination on which one might be easier to use. As you can see the Stik product is very simple and easy to use and it’s easy to get the results without accidentally compromising the test. All compounds used in the production of the product are already FDA approved.
“Much of the development has been completed and LifeSaver’s HIV Stik is scientifically proven to work in a lab setting. Additional lab work and clinical trials will be completed upon funding and a Fast-Track application will immediately be submitted for FDA approval.”
So now we can move on a bit and talk about a couple other neat things about the product. As you can see there’s no liquid involved in the testing material, which means a longer shelf life, and the Stiks can withstand some pretty warm conditions with no special storage or handling required. The cost for each test is estimated to be around $12 retail for each Stik which is certainly very affordable. When you stop and think, a simple test as such could be distributed world wide and again make it simple and easy for all concerned whether it’s a clinic or an individual taking their own test. Let’s take a look at what the Stik technology could do for the Red Cross. You may or may not be aware that the FDA has inspected and fined the Red Cross here in the US for compliance failure and right now as I read recently, there’s a shortage of blood in supply. This was in January of this year and instead of a fine would it not be better to have the situation corrected?
Now let’s move on to another topic with LifeSaver Stik products, drug and alcohol testing. This is also an exciting area of development. How often have you wondered after enjoying alcohol if you are safe to drive. LifeSaver has a simple solution for that as well and it’s the same process as above, lick the Stik and wait two minutes. If one is over the legal limit of .08 a plus sign will show and if below, the minus sign will show. Just this simple test can give you a quick answer and would it be nice if restaurants, pubs, etc. made these available?
“The Alcohol Stik can be made with any alcohol cut-off value between 0.02% and 0.30% or with a simple Pass or Fail to meet various market needs. Clinical trials have been completed and has received certification from Norton Medical Industries that the Alcohol Stik meets or exceeds DOT, FAA and FDA requirements. Upon funding, a 510(k) application will immediately be submitted for FDA approval.”
Now let’s talk about drug testing and if you are like me and have worked for any large or even a smaller company you have probably had to go for a drug test. In my former life I worked in logistics and we had random tests from time to time for everyone at the facility so that routine has been around for a while and the trips to a lab are not a lot of fun, so what if this process were made easier. Let’s talk about pre-employment, take your drug test at the interview/offer process perhaps? A total of 7 tests can be loaded on one stick.
“Ttest’s Drug Stik provides a scientifically reliable indicator of the presence of drug metabolites and alcohol in the test subject in seconds, simply by wiping the indicator stick across the tongue. A minus sign (-) indicates the subject is negative and a plus sign (+) positive for each of the targeted drugs and alcohol. The Drug Stik tests for DOT and FAA mandated drug screening also known as NIDA-5, which include: phencyclidine (PCP); opiate metabolites (heroin, morphine and other similar drugs); marijuana and marijuana metabolites (THC); cocaine and cocaine metabolites; amphetamines (including methamphetamine) and alcohol. Much of the development has been completed and the Drug Stik is scientifically proven to work in a lab setting. Clinical trials will be completed upon funding and a 510(k) application will immediately be submitted for FDA approval.”
Again with all the news today about HIV testing, it seems as if this was a good time to talk about LifeSaver Products and all the possibilities at hand.
If you would like to see some additional information, please check out the LifeSaver or you can email me for a link where a business plan and projections are further explained. This looks to be the next step in providing simple and inexpensive testing services that could have a big impact worldwide.
Disclaimer: I provide consulting services to LifeSaver products.
If you read here often enough then you might be familiar with the “Blue Button” and if you are not aware as a member of the military and VA, you can get your medical records by signing up and downloading it. Below you can read the accounting of one process where a Naval Officer used it at Walter Reed. This is a perfect example of how having your medical records available not only saves time but also shows the value. The links below has additional information on how to get started.
To continue on with this story, when the Naval Officer arrived at Walter Reed hospital, the system was down and this happens everywhere but when you see what he did to get his records, he was prepared. Again having this information with you and accessible just could save your life. Again this is a great story as unlike most other news articles you read, it’s someone telling you about how great it is from someone who has never used it and we do have a shortage of those in government that will step outside and be a role model to share personal experience for sure, just the so called “experts” that want to tell you it’s good for you and don’t participate themselves and I call them “magpies” in the world of consumer health IT and thus so “magpie healthcare” seems to continue to populate the news with those who don’t participate themselves.
The video below gives you some additional details on how this all works.
While this is good for veterans, it’s also important to remind you that if you are on Medicare, you can do the same thing as you have a “Blue Button” there too. Information is right on the front page of Medicare.gov.
Back on track, the naval officer whipped out his phone and downloaded his data and with it the folks at, Walter Reed, even though their systems were still down, were able to begin his treatment and didn’t run the risk of giving him a drug that could cause issues or problems…it paid off. Now we all talk about formats of the data and information and some of this is work in progress, but did it make any difference to the naval officer needing treatment..nope. When needing care the formatting of the data took second place and he had his information he needed for treatment!
Continuity of Care document standards are what makes it possible for the data to be used in a medical record system and some like HealthVault can do that for you and there’s been a lot of work done in this area and it will continue to grow, but for goodness sakes, take that pdf or text document and use it if that’s all that is there and don’t worry about formatting until it becomes available. In his case the EHR system that could accept or read the data was down anyway. The link below shows how the Blue Button and HealthVault work together so once you have it there, the rest of your information in HealthVault is combined for a more complete PHR.
MyMedicalRecords also works with the Blue Button and you can import your records into their PHR as well.
Again nice to have someone share their story here and we could use a lot more of these on the web showing the value of a PHR (personal health record) and I’m sure in the near future we will see more integrations processes with the Blue Button
Until recently, I took only a passing interest in Blue Button, the Department of Veterans Affairs’ (VA’s) app that allows veterans to download their health records to a computer, mobile device, or jump drive. I realize this probably reflects poorly on me given the fact that I’m a health IT journalist, but I guess I viewed Blue Button more as a nifty feature on the VA’s online patient portal, My HealtheVet, than a game-changer in the world of HIE (health information exchange) and patient engagement. Quite frankly, in the wake of Google Health’s demise, I didn’t think many veterans would even be inclined to use Blue Button.
Craig is a former Naval commander that acquired a service-connected disability that confines him to a wheelchair. On top of that, Craig has a rare (only 500 to 1,000 cases known worldwide) neuromuscular disease called PLS (primary lateral sclerosis). PLS is characterized by progressive muscle weakness in voluntary muscles. There is no cure for PLS, but its symptoms are treated using a ‘cocktail’ or more than a dozen ‘off-label’ prescription medications.
“When we arrived at Walter Reed, their system was down and the doctors were unable to access my health record,” says Luigart. “I told them I had PLS, and the physicians really wanted to have a full understanding of the medication cocktail I was on prior to treating me for my head injury. I whipped out my iPhone, logged onto MyHealtheVet, and downloaded my health data — complete with prescription dose and frequency. Without Blue Button, I would have either been forced to wait for Walter Reed’s system to come back online before I received treatment, or been subject to a potential adverse drug event if the physicians decided to treat me without full knowledge of the prescriptions I was already taking.”
Plus, does the notion that Blue Button isn’t based on the CCD standard make Craig’s story any less impactful? Nope. In fact, in Craig’s scenario, the EHR system that stored his medical record was unavailable. It was the fact that Craig was able to access and provide physicians with his health record when the EHR system couldn’t that made his account so compelling, and ultimately may have saved his life. CCD compatibility is definitely one way Blue Button can be enhanced to add a greater convenience to providers and patients, but it doesn’t dictate its value.
Blue Button does prove one thing — there is a large contingent of patients out there that want control and access to their health records. To date, more than 376,000 unique registered users have downloaded more than 900,000 health data files through Blue Button. Rather than dwell on its perceived weaknesses, the health IT industry would be wise to consider the progress Blue Button has made and improve upon the concept.
In Israel they are doing a lot of work with separating the constituents of grass it appears and the latest efforts show a focus on Cannabidiol, also called CBD which has strong anti-inflammatory benefits. The plants being grown are free of the THC portion, thus there is “no high” associated with using the plants grown without this component. So I guess after all there really is medicinal use for marijuana, although there have not been any clinical trials run to get some full accurate reporting. As you can read though, the aroma of the pot plants is still there.
The plants grown only contain less than 1% of the THC component, the part that gets you high. Patients in Israel who are already being treated with cannabis have access to the new strain, Avidekel and one patient commented that she can use it more frequently now for her pain as she says without the “high” she can function better without the side effect. BD
(Reuters) - They grow in a secret location in northern Israel. A tall fence, security cameras and an armed guard protect them from criminals. A hint of their sweet-scented blossom carries in the air: rows and rows of cannabis plants, as far as the eye can see.
It is here, at a medical marijuana plantation atop the hills of the Galilee, where researchers say they have developed marijuana that can be used to ease the symptoms of some ailments without getting patients high.
"Sometimes the high is not always what they need. Sometimes it is an unwanted side effect. For some of the people it's not even pleasant," said Zack Klein, head of development at Tikun Olam, the company that developed the plant.
But cannabis also contains Cannabidiol, or CBD, a substance that some researchers say has anti-inflammatory benefits. Unlike THC, it hardly binds to the brain's receptors and can therefore work without getting patients stoned.
Avidekel is a new strain of a plant that is already permitted for medical use so there is nothing stopping patients who are already being treated with marijuana from trying Avidekel. About 10 patients began using it in the past six months, Klein said.
"The cannabis plant, enriched with CBD, can be used for treating diseases like rheumatoid arthritis, colitis, liver inflammation, heart disease and diabetes," she said, adding there are no side effects. "The difference is huge. Before, I would only smoke at the end of the day and stay in pain." Now, she said, with the highless marijuana "my life is so much better."
It was just a couple weeks ago that M*Modal announced their new software suite to work with medical records companies to incorporate unstructured data into medical records. This has been an issue with reading the text and appropriately containing in an EHR.
M*Modal with their speech recognition seems to be about the only competitor with Nuance as far as I have seen. Their product works in the cloud with recognizing key words and other relative bits of information in patient narrative unstructured data. it will be interesting to hear some feedback on how this works as well. BD
FRANKLIN, Tenn. & NEW YORK, Jul 02, 2012 (BUSINESS WIRE) -- M*Modal (mmodal inc. -- nasdaq/gs:MODL), a leading provider of clinical documentation services and Speech Understanding(TM) solutions, and One Equity Partners today announced that they have entered into a definitive agreement pursuant to which One Equity Partners, the private investment arm of JP Morgan Chase & Co., will acquire all of the outstanding shares of M*Modal for $14.00 per share in an all-cash transaction. The transaction is valued at approximately $1.1 billion.
Investment funds affiliated with S.A.C. Private Capital Group LLC (S.A.C. PCG), collectively M*Modal's largest shareholder owning approximately 31% of M*Modal's outstanding shares in the aggregate, have agreed to tender their shares into the offer and to support the transaction. S.A.C. PCG is a private equity firm managed by the founders of Siris Capital Group, LLC.
Dignity Health was formerly know as Catholic Healthcare West. Regulatory approval is still needed. With the purchase this expands Dignity into more of a national healthcare company and they also plan to expand the number of facilities. Occupational healthcare has been a primary focus as well as some urgent care centers. Goldman Sachs was the financial advisor for the deal. US Healthworks will continue to operate as a separate subsidiary.
From the website:
”Based in Valencia, California, U.S. HealthWorks Medical Group was founded in 1995. With 140+ medical centers in 15 states, with 2,000 employees including approximately 350 affiliated physicians – U.S. HealthWorks centers serve thousands of patients each day throughout the country. We help employers control work-related injury costs through quality medical care and effective management of claims and lost work time, while specializing in early return-to-work, injury prevention and wellness programs”
The last time Dignity was in the major news it related to the big lawsuit for sexual harassment. BD
San Francisco-based Dignity Health said today that it has signed a definitive agreement to acquire U.S. HealthWorks, which bills itself as the largest independent operator of occupational medicine and urgent care centers in the United States.
The deal is subject to regulatory approvals and is expected to be finalized in August. Financial terms were not disclosed.
Based in Valencia, U.S. HealthWorks is a portfolio company of Altaris Capital Partners and Three Arch Partners. It operates 172 sites nationwide, employing 2,700.
There’s all kinds of allegations in here from off label marketing, safety data, false pricing practices and it went on for 9 years. That’s a long time but this is big fine too. I’m sure the patient whistleblowers will get a little bit of this, although nothing has been said so far. No more goals for territories for sales reps. That sounds realistic with where we are today so reps are not drug pushers as the blockbuster days seems to be behind us. In an earlier whistleblower case in Puerto Rico 60 minutes did a real in depth story on how manufacturing problems and politics created yet another fine last year. The link at the bottom of the post has the actual announcement from the DOJ. BD
Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
Now this is a crock of story and why were the doctors not allowed in to get their patient records. I am guessing they were maybe not on an EMR of any sorts? Still though, come on give folks notice as the secondary entrance was not life or death. The landlord wouldn’t let them in. When you read this article it is real blame shifting here as the landlord said they could get in as long as the building department said it was ok and then the building department said the doctors could be given permission from the landlord!
Doctors had no offices for almost 3 weeks to practice. Nobody cared about the doctors and patients here it sounded like, just the secondary entrance took center stage…again how dumb. BD
SHEEPSHEAD BITES EXCLUSIVE: The city suddenly shut down a medical center in Brighton Beach in June, leaving several doctors with no place to work and no access to their medical records for as long as two weeks.
The medical center, located at 2965 Ocean Parkway, was closed June 13 by the New York City Department of Buildings for lacking a secondary means of egress, a technical term for an entrance and exit. The four-story building had only one open staircase, but, Department of Buildings regulations require an additional staircase for a building of such size in case of an emergency.
Furthermore, patients had trouble reaching their doctors being that the office was closed for as long as two weeks, and with no access to files, doctors had trouble reaching their patients.
“In the future, if the department feels a building is unsafe, they should have a procedure in place to give workers access to their important information,” Singer said.
This is pretty good as he is seeking all profits made by the executives and board. In this case revenue cycling and pay for performance methodologies hit the wall, why else would you have employees using such aggressive tactics to collect money?
If one is a board member today with any company using a great deal of technology you might want to inquire about their algorithms and software and make sure you have a top notch IT department as that’s how this whole thing got out of the bag with nine stolen notebooks…did you read that right…not one but nine and the last being the worst to where it was uncovered that patient privacy rules were violated with Wall Street analysts being able to view and see real patient records. That’s the deal today if you are going to be a board member or executive, no more mister naïve guy at the helm as we have enough of those, ie. the CEO of Nasdaq and Jamie Dimon who are either that naïve or just play dumb. The folks from Accretive didn’t satisfy Congress either and it seems “playing dumb” is becoming a defense today. Actually this situation became chapter 28 of the Attack of the Killer Algorithms.
Look at where one of the other directors works…Warner Music Group..what does these folks know about running a healthcare company one could ask..just send check please for my existence here:) One shareholder wants his money back from the directors as he saw they were asleep at the wheel with everyone saying “I had no idea”…in today’s world that’s not going to last too much long I don’t think. Last I knew directors were supposed to give and offer guidance right? How do I get one of those naïve board or CEO director jobs I wonder:) BD
CHICAGO (CN) - Business titan Edgar Bronfman is lead defendant in a shareholder derivative complaint against Accretive Health and 10 of its directors, who are accused of concealing the company's "deplorable" debt collection practices, which allegedly discouraged patients from seeking life-saving treatments and violated medical privacy laws.
Lead plaintiff Jeffrey Goodwin sued Edgar Bronfman, Accretive Health, nine other corporate officers in Cook County Court. One of the director defendants is former Secretary of State George Shultz, a director emeritus of Accretive. Bronfman, the CEO of Warner Music Group, is a director of Accretive Health, which "provides revenue cycle management services for hospitals and healthcare providers in the United States," according to the complaint.
Goodwin seeks damages for breach of fiduciary duty and proposes new procedures to improve internal oversight of Accretive's corporate officers. He also seeks restitution of all profits and benefits obtained by the individual defendants. Also named as defendants are Accretive directors Michael Cline, Steven Kaplan, Stanley Logan, Denis Nayden, George Shultz, Arthur Spiegel, and Mark Wolfson, and CEO Mary Tolan and CFO John Staton.
The Tri-Care contract situation if you have followed it for the last couple of years has been interesting. Tri-Care has 3 regions and all 3 were contested on the initial awards and sent back out for bids again. I have a hard time keeping up with it as this is the battle of the big insurers here. The latest is the website from Tri-West, who was the incumbent who had serviced the military for a long time and recently lost the contract to United. United sued the DOD so did this have any impact? Who knows as I’m sure the costs of a full on lawsuit were in someone’s business intelligence analytics to project the time and money would estimate to come out to.
You can read below and see where Tri-West said their contracted rates were lower and I kind of summed it up in an opinion piece, “my algorithms are better than yours”..it is what it is with contracts today and the “sale” of analytics to prove their points.They all do it but United is so huge with tons of subsidiaries that nobody even thinks about. I have written about many of them and you can so a search here with the words “subsidiary watch” and find a big selection of blog posts. In southern California and in other areas too United is buying up physician’s group at speeds that seem to outpace the other insurers, and big ones too.
If you were to break down and really look at all the subsidiaries under the United corporate blanket they almost have a company that could handle everything from introducing a drug to the FDA all the way down to physician/hospital reimbursement.
Will politics and lobbying enter the picture here, seems it’s everywhere else so keep your eyes open. One other little tidbit worth mentioning is the fact that they hired the former US Attorney General in Minnesota to work as general counsel a few months ago and then a couple weeks ago the executive at HHS who was credited with creating most of the healthcare reform laws left and went to United…some of this stuff just makes you go hmmmmm…doesn’t it. You can’t help but think that when one crosses over from government over to the private area, now more than ever with everyone looking at every cent you can’t but think “find the loopholes” might have a bit of impact. Former government employees could make for good corporate lobbyists in this area, you think? What else are they going to do over there, I’m open for any other input on this topic.
Meanwhile back at the ranch HHS director Sebelius is still looking for tech to save the day and fiddling around with social networks, while United looks for tech to take care of the shareholders.
Another United subsidiary was discussed on the web recently,Golden Rule Insurance company (one I have previously missed with subsidiary watch posts) being a “poster child” for price gouging with the medical loss ratios where it owes money in 25 states and they owe more money than any other insurer . It’s all in how “those algorithms” figure the pricing and analytics today. It looks like United threw Palmetto a bone here too as they probably need their services for at least a while until they figure out how to buy them or put in their own payment services. Palmetto is also a subsidiary of the Blue Cross Tri-West Group.
So if you want to help Tri-West, the subsidiary of Blue Cross keep the contract you can visit the site and read up and see what’s going on at the website. The contract has over $20 billion in revenue at stake. Tri-West says the data was flawed and he might have a point there as I talk about flawed data at this blog all the time as it’s growing. Take a look at my series called “The Attack of the Killer Algorithms” for some real life examples. BD
“Our record was thoroughly evaluated in the T-3 Contract decision, as should be the case, and we earned the highest rating. However, UnitedHealthcare’s record was not. The Department of Defense failed to review generally available information about UnitedHealthcare and its extensive track record of problems with doctors, patients and governmental authorities—issues that have resulted in hundreds of millions of dollars in fines, penalties and legal settlements. Additionally, TriWest was lower on price than UnitedHealthcare. At a time when the Department of Defense is struggling to make ends meet and attempting to cut costs, they awarded the T-3 West Region Contract to the highest cost bidder.”
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