tufts medical center: Temmuz 2012

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.

FDA Approves Genetic Test To Help Patients and Doctors Determine If Erbitux Would Be an Effective Treatment For Colorectal Cancer

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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.

EHR System Installed at Hospital in Australia Was Gamed by Executives With Manipulating Emergency Department Records, Wait Times And More to Improve Publicly Reported Statistics

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I wonder has anyone in the US caught on to this game yet? I think our systems here are a little too tight for this to happen as it sounds like this installation was not very well done anyway. An executive admitted that he did it but gee if you are going to get in there and alter data for statistical purposes and the goal is to be within parameters, this looks kind of stupid to see an high number of patients checked out of the emergency room precisely 240 minutes after arrival. I would think that would stick out like a sore thumb. In addition round numbers were used as patients were seen exactly in 30 or 60 minutes from the time they arrived, again no imagination here and I guess someone thought nobody would ever look, wrong, not in today’s world of data.
So instead of being within the normal realms of statistics, they were way over the other side. The patients seen within 30 minutes was 19% over stated. In addition it was all done from one workstation, duh? Next odd issue here is that the hospital has 259 workstations and only 23 user accounts? Duh again like what’s up with this? 253 people had user accounts but only 23 users? The main four generic user accounts were: CLERK, NURSE, DOCTOR and BEDMAN and anyone in the hospital could use the accounts!
The system, EDIS was not able to edit effectively either, again with all input coming from one work station. How in the world does this happen, I can’t believe this. The fact that someone outside of IT could get inside and do all of this is amazing so maybe there was a plan or reason for using only one workstation.

The article also said up to 72 hours after the visit that records could be changed and that is non unusual as long as you have an audit trail recording each change in case it was legally needed later. Heck I even wrote that in my system 6-7 years ago. Well obviously some folks figured out how to work the system and I wonder how the patient records looked, not that they were altered I am guessing but what kind of data was entered there? How can you run an ER on one workstation and four user accounts? Well after this incident I think many will be talking about some enhanced security soon. BD

A Canberra Hospital executive has admitted to manipulating Emergency Department records to make wait times and stays appear shorter than they were.

The executive told the Director-General of the Health Directorate they had made "approximately 20 to 30 changes to hospital records" a day from "late 2010" onwards.

ABC News reported that the matter has been referred to police, while the executive has been suspended without pay.

In total, PwC found 11,700 performance records - about six percent of all records stored in the hospital's iSOFT emergency department information solution (EDIS) - had been altered.

While EDIS was on approximately 259 workstations across the hospital and 253 users had permission to run the software, there were only 23 user accounts.

"Although EDIS has been disseminated widely throughout the Canberra Hospital each of these users logs into EDIS using the common “Workstation 14”.

Though the data manipulation was initially said to be motivated by concerns over job security, changes in 2011 and early 2012 were said to have been made due to "managerial pressure" to improve publicly-reported performance statistics.

http://www.scmagazine.com.au/News/307389,canberra-hospital-embroiled-in-data-scandal.aspx

WellPoint to Buy Amerigroup for $4.9 Billion As the Battle for Medicare and Medicaid Management Contracts/Exchanges Continues Between Two Major Health Insurers–Subsidiary Watch

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In case you have not paid attention lately to what appears to be happening here there’s a big battle going on with contracts with health insurers. This has been a big area with the Tri-Care contracts as well with United recently winning the west coast contract to administer. But even in the midst of all of this with the subsidiary companies, United apparently found it necessary to award a portion of the contract they won to a Blue Cross subsidiary, as I am guessing all the IT infrastructure that was in place presently would be a huge project to move quickly. It’s all about that IT infrastructure and algorithms.

United HealthCare Awards Contract to One Blue Cross/Blue Shield Subsidiary to Process Tri-Care Claims While The Other BlueCross BlueShield Company Lost the Over All Tri-Care Bid To United In the West

Here’s another recent example below of a battle between the two insurance giants duking it out over who gets the contract, all about those cost and risk algorithms and their respective parameters of predictions that keep falling off the scales today as things change so rapidly.

Blue Cross and United Healthcare Duking It Out In Nebraska Over State Health Insurance Contract–We Have More Subsidiaries My Cost Algorithms Are Better Than Yours?

Blue Cross Protesting Award of Texas Employee Retirement Health Plan to United Healthcare–Price Cut by $25 Million With Little or No Out of Network Coverage for Members

In addition of late, WellPoint also bought this company who makes contact lens and perhaps this was in answer to United and their “cheap hearing aides” company they bought a few months ago, so one may have a deal on contact lenses and glasses and the other has hearing aides.

WellPoint to Purchase 1-800 Contacts Eyewear and Contact Lens Retailer For Around $900 Million–Subsidiary Watch

UnitedHealthCare Throws in Free Hearing Aids for Those Who Enroll In AARP Medicare Advantage, HMO & POS Plans in Miami-Dade County From Their New Subsidiary

This activity is noted to somewhat prepare for State insurance exchanges which in itself will be interesting to see how that works as IT infrastructure is becoming so complex these days and “will they” be able to do it without a huge array of flawed data in there, and of course usual and customary legal battle of who received which contract. All of this stuff just fills the news wires today and continues to keep consumers in an uproar and state of confusion until someone settles the matter and then again even when that is accomplished, flawed data and spasmodic algorithms live on. The VC firm owned by the Blues just recently moved to San Francisco and started an incubator for start ups and let me see, I can bet some of the new companies will be focusing on the payable areas as well as new parameters that will help determine risk and benefits…that’s what they do out there today.

Here’s one more example of WellPoint and their preparation for exchanges..they bought their own but still want to be in the game for what the government is going to dole out too. WellPoint may have an disadvantage here to a degree as the former HHS executive who wrote the healthcare laws is now on the payroll at United Healthcare as an Optum VP, so loopholes or other items in the complex IT contracts could be easier to locate, again this is a battle of IT to determine risk and how to profit.

WellPoint & Partners Buy Bloom Private Health Insurance Exchange From Their Own Venture Capital Company (Sandbox) –Subsidiary Watch

Meantime back at the consumer ranch, when we get sick we just hope there’s someone around to pay the bill so we don’t end up filing for bankruptcy and losing what we have left, i.e. homes. Both of the carriers are also buying up HMOs such as CareMore bought by WellPoint and then you have a few giants under the care of United in southern California to include Memorial Care and Monarch and there’s more out there too that are smaller that have been gobbled up by insurers.

As I read this article, this would put WellPoint in the number one spot for having the most covered under Medicaid contracts and at this point it looks like United still holds the number one spot for Medicare, I think? This is the world we live in today and hopefully by the time all the big corporations figure out their algorithms and what risk and profit exists for them, as consumers we can hopefully still get some decent care and have doctors that are not cut to the absolute brim to where more private practices continue to close.

That’s a big issue out there today as of course insurers drive those rates and we get shuffled from one area into another, like a cattle call with contracts as it’s in constant motion and keeping up with the contracts is a complex issue for not only consumers but also doctors and hospitals. In the meantime too, let’s not over look the money that stands to be made from combined efforts here too with selling data, insurers make billions do this as well as other industries. With all these mergers and acquisitions, the very least we can do is to at least start taxing these huge profits on a quarterly basis and think about devaluating some algorithms before the big bubble bursts, as at some point in time it will as something has to give here. BD

“Devaluate the Algorithm” And “Tax the Data Sellers”–A Cure for Both Healthcare and an Economy Based Heavily on Intangibles–We’ve Lost Our Balance

WellPoint Inc., the second-biggest U.S. health insurer, agreed to buy Amerigroup Corp.for $4.9 billion in cash to expand the number of Medicaid patients it serves as the U.S. health plan for the poor undergoes broad changes in how it is managed.

Amerigroup stockholders will receive $92 a share, the companies said in a statement today. The price is 43 percent higher than the closing level on July 6 for the Virginia Beach, Virginia-based company. WellPoint, based in Indianapolis, rose 5% to $62.89 at 6:30 a.m. Pacific time.

The acquisition will make WellPoint the top private manager of Medicaid benefits in the U.S., with 4.5 million members in the program. The deal should also boost the value of other insurers focusing on Medicaid, includingWellCare Health Plans Inc.andMolina Healthcare Inc., said Thomas Carroll, a Stifel Nicolaus & Co. analyst in Baltimore.

UnitedHealth Group Inc., based in Minnetonka, Minnesota, is the largest Medicaid contractor with 3.5 million members. Medicaid is the joint state-federal program for the poor, while Medicare serves the elderly and the disabled.

http://www.latimes.com/business/la-fi-wellpoint-20120709,0,7872259.story Technorati Tags: WellPoint,Amerigroup,healthcare,health insurance,HeatlhIT,mergers and acquisitions

FDA Approves Evolution Colonic Stent To Relieve Pain and Assist With Obstructions Prior to Colectomy Procedures

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The stent is said to potentially eliminate multiple procedures and if you are familiar with Cook Medical they make quite a few stents for use in treating PAD and pulmonary areas so we have a stent for another part of the body. The mechanism makes it easier to place and retract the stent and can provide relief to those with colon cancer with relieving pain associated with obstructions. I am thinking that with other colon diseases where pain and discomfort enters such as irritable bowel or maybe even Crones disease, or any other disorder of the bowel area this could prove to be an effective therapy. BD

Press Release:

Winston-Salem, N.C., July 9, 2012 — The U.S. Food and Drug Administration (FDA) has granted Cook Medical 510(k) clearance for the Evolution® Colonic Controlled-Release Stent, Cook announced today. The new stent expands Cook's line of Evolution controlled-release stents and is used to palliate uncomfortable symptoms associated with colonic obstructions caused by malignant neoplasms and relieve large-bowel obstructions prior to colectomy procedures. The product's design offers physicians the control and maneuverability required to deliver a stent that conforms to the natural curves of the anatomy.

In a recent multi-center, international registry study of 80 patients, the Evolution Colonic Controlled-Release Stent was evaluated for use in palliation of symptoms and as a bridge to surgery. Resulting clinical success rates were 97.8 percent and 85.7 percent, respectively. At least 85 percent of patients in both groups reported mild or no symptoms of abdominal pain, difficulty defecating or constipation at the first post-procedure report.

There were no adverse events associated with device malfunction and no deaths were considered to be caused by a device complication.¹

The American Cancer Society estimates that more than 103,000 new cases of colon cancer will be reported in 2012 in the U.S. alone.² Some patients with colon cancer may experience colonic obstruction, which can be painful and uncomfortable.

The Evolution colonic stent helps physicians reduce the symptoms associated with obstruction, which can include abdominal pain, vomiting, nausea, difficult defecation, constipation, diarrhea and GI tract bleeding.

The Evolution Colonic Controlled-Release Stent and delivery system include several features designed to provide control and maneuverability to physicians. These features include a stent design that provides enhanced expansion and better wall apposition and a unique delivery system that employs kink-resistant Flexor® technology for pushability and stability.

The delivery system, which is the same across all Evolution stents, provides physicians with a trigger action that deploys — or recaptures — a proportional length of the stent for precise placement. The Evolution colonic stent also adds a highly visible endoscopic marker to define the proximal end of the stent.

“The new Evolution colonic stent reiterates Cook Medical's commitment to pioneering a full line of efficient, effective products to improve the quality of life in patients who suffer discomfort or pain,” said Barry Slowey, global business unit leader for Cook Medical's Endoscopy division. “Now clinicians have the ability to precisely deploy and recapture colonic stents. That can make it easier to place the stent the first time around, potentially reducing the need for repeat procedures, while increasing efficiency in the GI unit.”

The Evolution colonic stent is now available to select physicians across the United States, and will be widely available in the coming months. The Evolution colonic stent adds to the existing line of Evolution stents, which includes fully covered, partially covered, and uncovered esophageal stents, as well as the duodenal stent which received FDA approval in March of 2011.

About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving more than 40 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter and LinkedIn.

¹ Repici A, Ter Borg F, Giovannini M, et al. Treatment of colonic obstruction with the Cook Evolution® Colonic Stent System. Dig Liver Dis. 2012;44(2):9.

² American Cancer Society. Cancer Facts and Figures 2012. Atlanta, GA: American Cancer Society; 2012.