FDA Approves Bayer Colon Cancer Drug Stivarga to be Co-Marketed by Onyx Pharmaceuticals

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Stivarga in clinical trials was shown to extend lives a little bit over 6 months.  It is the second drug  approved within the last couple of months for colorectal cancer.  Patients in the trail also showed a delay in tumor growth.  It does carry a black box warning that it can cause toxic liver problems and other common side effects include weakness or fatigue, loss of appetite, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia).  The drug works by blocking enzymes that promote cancer growth.  BD

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WASHINGTON--The U.S. Food and Drug Administration on Thursday approved a new drug developed by Bayer AG (BAYRY, BAYN.XE) to treat colon cancer that hasn't responded to treatment with currently available therapies.

The drug, which will be sold with the brand name Stivarga, will be co-marketed in the U.S. by Onyx Pharmaceuticals Inc. (ONXX). The company will receive a 20% royalty on global net sales of the product, also known by its generic name regorafenib.

Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. It is meant to treat patients with colorectal cancer that has progressed after treatment with other drugs and spread to other parts of the body.

http://www.nasdaq.com/article/fda-approves-bayer-ag-colon-cancer-drug-stivarga-20120927-00764

Common Parasites Carried by Cats Reduces Inhibitions–In the Cat Host and Also With Humans If Exposed to Cat Feces by Increasing Dopamine..

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This is an interesting journal publication and not sure if I’m in on this one as far as believing it but the video is kind of funny.  Clean out the litter box for your cat and get exposed and go out and have a good time:)  It has to do with increasing dopamine in the brain and hormones and it does the same for the cat too.  Sounds like this is an interesting parasite and what are the downsides here?  If the host is a rat then it loses is sense of fear from cats and thus gets eaten.  As I understand it the parasite needs to have a cat or a mouse around to host it so it sounds like as a human you need to be re-exposed as in cleaning out the litter boxes?  Watch the video and see what you think, I just think it is a bit strange.  BD



Pop culture rhetoric doesn't shine favorably on cat people, but new science might change some of those negative perceptions. 

Research into a parasite commonly carried by cats (or found in raw steak) shows it increases extroversion and makes humans less conscientious overall.

The parasite, called toxoplasma gondii, "manipulates the behavior of its animal host by increasing the concentration of dopamine and by changing levels of certain hormones," said a study in the European Journal of Personality.

http://news.discovery.com/animals/cat-parasite-improves-social-life-gotta-see-video-120926.html#mkcpgn=rssnws1

Maryland Insurance Contract Negotiations in Maryland At a Standstill as CareFirst BlueCross Blue Shield Objects to Private Insurers Paying a Higher Percentage on Hospital Bills Versus Medicare Discounted Rates

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When you think of Maryland and hospitals one that stands out of course is Johns Hopkins and would be included in the Maryland Hospital Association negotiations on rates.  Maryland is the only state that sets hospital prices for all payers to include Medicare.   Medicare rates though have to stay in balance with the the percentage in the rest of the country though to enable this practice to continue; however the state is nearing the breaking point and is looking for private insurers to help keep this balance with higher rates. 

So the solution here is to give Medicare and Medicaid discounts to keep HHS happy with costs there and raise it around 7 percent for commercial payers over 3 years.  Commercial carriers also pay far less of the hospital bills than does Medicare so a smaller exposure there.  It’s the same old story as far as the mix of commercial payers to Medicare and almost every hospital in the US is aware of how this works when all they need to do is look at their budgets.  As of now everyone has come to a stop.  In other states some Blue Cross groups have bowed out of covering some medical centers where they say the price is too high, like here in southern California where the city’s Blue Cross plan states UCLA and Cedars Sinai charge too much. 

Los Angeles City Blue Cross Employee Health Plan Kicks Out Cedars-Sinai and UCLA Medical Center in New Contract Says They are Too Expensive-Subsidiary Watch

HHS steps in and asks for cost controls all over the system and I’m sure there’s a lot of that going on already but they are kind of out of touch too as we had this story earlier this week with accusing hospitals of “gaming” the system, which I said is kind of a witch hunt as we are dealing with raw hard numbers now and it kind looked silly and then later another news announcement came out where the government said they are partially at fault..again folks who don’t know math and code and still look for a head to hang some of this on.  Outside of the obvious abuse cases which are criminal and should be investigated and prosecuted we have hospitals that have paid a lot of money on how to code properly and use consultants to help them do so and HHS doesn’t sound like they were ready for it.

HHS and DOJ Send Letters to Hospital Trade Associations Warning of Gaming Billing System Via Use of Electronic Medical Records–Hospitals Just Learned How to Bill Better & Hired Consultants–Case of Being Algo Duped With Numbers?

So for now everything is at a stand still.  Hospitals had to get better at billing and revenue cycling, as have you seen how many have gone out of business or gone bankrupt?  These contracts and rates are a bear for sure so what’s the next move on this one?  Do they with draw from Johns Hopkins and a few others they may determine charge to much?  One really needs to see the number split to talk further though to see what the spread is on Medicare/Medicaid to private insurers.  If insurers were at a small number and way below half it might not be that big but again need numbers to figure it out.  BD

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Negotiations to avert a breakdown in Maryland’s unique system of regulating hospital prices have deteriorated into a stalemate between the state’s largest insurer and the Maryland Hospital Association. CareFirst BlueCross BlueShield CEO Chet Burrell, speaking out for the first time about the talks, blames hospitals for their proposal to shift hundreds of millions in costs to CareFirst and other private insurers in an attempt to control rising Medicare spending.

Maryland is the only state that sets hospital prices for all payers, including the federal Medicare program for seniors and the disabled. It’s allowed to do so only so long as Medicare costs per hospital admission rise no faster over time in Maryland than in the rest of the country. Because Maryland is close to breaking this speed limit for its Medicare “waiver,” medical providers and federal and state policymakers have been talking all summer about a redesign.

But the federal agency especially wants to rein in hospital Medicare spending. To address its concerns the hospital association has proposed giving Medicare and Medicaid sharp discounts while raising hospital rates for commercial insurers by 7 percent over three years — beyond normal health care inflation.

Once phased in, the plan would increase charges for companies such as CareFirst and their customers by about $350 million a year and boost their price for a typical hospital admission by $900.

http://capsules.kaiserhealthnews.org/index.php/2012/09/md-blues-chief-blasts-plan-to-shift-hospital-costs-to-insurers/?utm_campaign=dw_tweets&utm_medium=Argyle%2BSocial&utm_source=twitter&utm_term=2012-09-27-09-36-47

Sears and Darden Restaurants Will Begin Offering Employees Cash to Buy Their Own Health Plans Through Online “Private” Exchanges With Contracted Insurance Companies

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So here’s the first step of employer insurance going away.  Both of these companies are self insured so what a way to kick a lot of the administration out of human resources and save money.  Companies have used similar plans for years to where a dollar amount is give and employees choose from a number of plans with their budget allowed and if more is desired it is available but it comes out of the employee’s pocket to make up the difference with health insurance plans.  Sears and Darden restaurants are trying this out to become effective the first of the year. 

The employees will choose their selections through an “exchange” not to be confused with the “exchanges” that states are setting up.  It sounds like the difference here is that it will be done online versus how it has been run in the past and the companies will still have their contracted insurers listed as choices.  Back to the self insured side these are “group” plans so again it is a bit confusing here, but that’s what insurance plans do these days, confuse us.  UnitedHealthcare, Cigna and Health Care Service Corp., which operates Blue Cross and Blue Shield plans will be the choices and a couple others to bring this up to 5.  Interesting to see a subsidiary of Blue Cross in here instead of a direct contract. 

This is kind of a hybrid plan it seems to set up for actual exchanges maybe later on as time moves on.  Again this is not a new concept as companies have had multiple contracts with carriers for years and offered choices.  I had a plan like this 15 years ago with United Healthcare, so I wonder who’s brain child was this..one good guess:)  Now with both employers having been self insured how exactly does this work?  Is the employee now going to deal direct with the insurers they select or will the HR Departments still run the administration of the contracts, or better yet will they hire yet another insurance company to come in an administer for the HR department and could it be one of the companies on the selection list?  Big corporations have been doing that for years with bringing in an insurer to administer the company health insurance plans. 

Will competition help keep the prices down, I doubt it.  The big carriers are still going to go after the government contracts and you see United and Blue Cross duking those out all over the place and appealing decisions and so forth and with the Tri-Care Contract, United Healthcare sued to get that one, so does that always work.

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

State of Louisiana Rejects United Healthcare’s Protest Over Awarding Blue Cross/Blue Shield Contract To Manage State Employee Health Insurance–Battle of the Insurance Algorithms Continues..

With the Tri-Care contract it will end up probably putting the one Blue Cross subsidiary out of business.

Tri-West Won’t Challenge Tri-Care Military Contract Loss To United Health - Legal Decisions & Contract Awards Allow Machines To Move Money for Profit As Company Will Likely Close Down-Subsidiary Watch

Sears also created a new subsidiary this year called Metascale  and they target customers with revenue over a billions such as healthcare to sell data services too.  Sears has been an open user of the Hadoop platform for a while now and sells it as well as server space so with all their data capabilities and what they have in resources they have to be cashing in at least making $1 billion a year on selling data as I compare them to Walgreens making just short of $800 million selling data in 2010.  Selling data too is one big reason corporate profits are up for a lot of companies. 

At a time like this with companies getting most data for nothing and huge profits for free with mining data it’s time for an excise tax as we keep paying more, premiums go up, NIH can’t get enough funds for valued research, FDA need money to get drugs and devices approved faster, and so on.  So new choices here and combined with big profits from data mining and selling, that’s how many of these companies are filling the pot of gold as we stand by and watch hospitals close and family practice doctors starting to become extinct.  It all about the business models and algorithms that are so complex that even the likes of Jamie Dimon can’t tell you how JP Morgan works, so this change represents some type of business model that will allow for greater profits and maybe we just can’t see it yet until it rolls out as we always have those unintentional consequences today with most business plans and their math.  BD

 

One More Good Reason to Tax the Data Sellers– Create Additional Funding for the NIH and FDA From Sources That Otherwise Are Too Greedy to Share & Contribute

The chat on CNBC video is interesting too in the fact that you have 2 financial experts talking about this and they both come right out and say they don’t understand their current plans, so right from the horse’s mouth about choice empowering employees…sounds to me like it’s more to deal with in this already overloaded data world.   BD

Sears and Darden restaurants offering cash to buy their own health plans. the company says it's not to save money. yeah, right. but do give workers more control. i always like that when they put it in there as a more controlled kind of thing. that's not the purpose of an employer, to give you more control. so you know at some level this is about saving money for the company. so what that means is over the long term health care costs are going to shift to employees. this is happening in a lot of big companies. they're considering -- here's what our yahoo.com poll says

http://video.cnbc.com/gallery/?video=3000118807&play=1#eyJ2aWQiOiIzMDAwMTE4ODIwIiwiZW5jVmlkIjoia1VDUmJTY3lHRlZCeFBoeHQzUFJtQT09IiwidlRhYiI6InRyYW5zY3JpcHQiLCJ2UGFnZSI6IiIsImdOYXYiOlsiwqBMYXRlc3QgVmlkZW8iXSwiZ1NlY3QiOiJBTEwiLCJnUGFnZSI6IjEiLCJzeW0iOiIiLCJzZWFyY2giOiIifQ==

FDA Approves S-ICD Defibrillator for Patients At Risk of Cardiac Arrest - First Subcutaneous Device That Works With No Wire Leads Placed or Attached to the Heart With a Less Invasive Procedure

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This sounds like very good news as you read in the news about wires needing to be replaced.  Here’s a couple of articles from the last 2 years and it has not been limited to one manufacturer at all.  I think be now we have all read the many news articles that have been out there and the risk involved with going back in to have the wires replaced as it takes a special doctor with experience in doing this as over time the wires become covered with our human tissue that grows. 

FDA Recalls St. Jude’s Riata Defibrillator Leads–Estimated 79,000 Patients in the US Implanted with the Device/Leads

Medtronic to Recall External Defibrillators

When you have one of these devices and you get a recall notice, it could mean surgery to replace the wires so this really looks to be a huge improvement from Boston Scientific.  They bought the company in California who make the device, Cameron Health and in May of 2010 it has already received the European CE stamp of approval.  The procedure takes about an hour to implant.  There’s a video at the website that shows an animation of how it is placed under the skin.

New Defibrillator Has No Wires Leading to the Heart – Clinical Trial in the US, Device has Europe CE Mark

We had to wait here in the US for the clinical trial to finish so the FDA was being safe with all the talk today about safe devices.  The company also provides a Patient ID card to carry with you and to show to airport security  as the device could trigger alarms.  One thing to note here, look at the cost of getting the device approved…Boston Scientific is paying an additional $150 million for the FDA approval…no wonder devices can be slow to be approved when you look at the cost.  In addition it was mentioned that Boston Scientific will be making payments back to Cameron Health, based on the sales as they only paid $150 million for the company so this appears to be a purchase of Cameron with contingency stipulations, again the cost and the small San Clemente company probably was nowhere near being able to afford the FDA submission and cost.  BD

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(RTTNews) - Boston Scientific Corp. (BSX:Quote) announced that the U.S. Food and Drug Administration has approved its S-ICD System, the first and only commercially available subcutaneous implantable defibrillator or S-ICD for the treatment of patients at risk for sudden cardiac arrest or SCA.

The company said that the S-ICD System sits entirely just below the skin without the need for thin, insulated wires -- known as electrodes or 'leads' -- to be placed into the heart. This leaves the heart and blood vessels untouched, offering patients an alternative to transvenous implantable cardioverter defibrillators (ICDs), which require leads to be placed in the heart itself.

The S-ICD System is designed to provide the same protection from sudden cardiac arrest as transvenous ICDs. The system has two main components: (1) the pulse generator, which powers the system, monitors heart activity, and delivers a shock if needed, and (2) the electrode, which enables the device to sense the cardiac rhythm and deliver shocks when necessary. Both components are implanted just under the skin—the generator at the side of the chest, and the electrode beside the breastbone. Unlike transvenous ICDs, the heart and blood vessels remain untouched.

http://www.rttnews.com/1974435/boston-scientific-says-fda-approves-subcutaneous-heart-defibrillator.aspx?type=qf