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Cookie Dough Shortage Looming – But A Fix is in the Works

That’s right you read the headlines correctly here, E-coli is back in the dough but the good news is that none of the product was released from the factory so imageretooling and testing the dough.  Nestle says the production of the new dough will begin January 25th, so in the meantime there may be a shortage on the dough.  The company says there’s no difference in the taste so if you need cookie dough, grab it now (grin).  BD  

Cookie dough addicts may need to find a temporary fix for their sugar craving: A change to the manufacturing process for Nestle Toll House cookie dough could lead to shortages in some stores.
Nestle USA halted production of the popular dough Wednesday as it converts its facility in Danville, Va., where the dough is manufactured, to one that uses heat-treated flour -- a change the company says will "enhance the safety" of its product.

On Jan. 11, Nestle informed the FDA that two samples of dough the company had taken at the facility tested positive for E. coli. The product never left the factory so a recall was not issued, Nestle said.

Cookie dough shortage feared - chicagotribune.com

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Health Insurance Companies Donate to Haiti – Appears to be Small by Comparison to Others Who Have Contributed

You can take a look here and base your own opinions.  These are the same companies that invest millions in technologies at the blink of an eye, but when it comes time for charity, to me anyway, it looks pretty slim.  Granted all the donations to Haiti are badly needed and appreciation for every dollar sent is there, but again when you look at how and where the current business models run, I just think they could do a little better.  We have many celebrities that on their own have donated a million on their own, companies who are struggling for their own existence, doing more.  I posted this a couple days ago where I commented on companies like Go Daddy, who are small in size by comparison to the insurance behemoths kicking in half a million, well you get the picture there.   

US Banks and Companies Donate to Haiti – Banks Should Give More and Hold Down Bonuses

UnitedHealth Group Inc. of Minnetonka, Minn., donated $100,000

Hartford, Conn.-based Aetna Inc.'s Aetna Foundation is providing $10,000 grants to each of six organizations to help fund their relief efforts.

The CIGNA Foundation, part of Philadelphia-based CIGNA Corp., donated $50,000 to the American Red Cross and said it would match another $50,000 in employee donations.

Let us not forget these are the companies we rely on for help to pay the bills when we are in need.  I included this widget for a quick update on where the situation is in Haiti.  You can read the entire list at the link to the story and I included just a few which are based to grow a bit, depending on what their employees contribute.  I know they all have good people working as employees, and for dollar amounts to increase,and in many instances it rests on the employees’ backs to make the amounts grow based on the algorithms put in place for these charitable programs to grow.   BD 

PORT-AU-PRINCE, Haiti—Several insurance industry companies have pledged donations and other types of assistance following Haiti's worst earthquake in more than 200 years.  The death toll from Tuesday's magnitude 7.0 earthquake, which devastated much of Haiti's capital city of Port-au-Prince, is expected to exceed 100,000, according to reports.

Insurance industry companies pledge funds for Haiti | Business Insurance

Medi-Cal in California Subsidized 50% – 38 States Have Higher Reimbursements Leaving California Subsidizing Other States

What is interesting here is that one of the states cited receiving more is Arizona at 65%, and I just posted that they are trying to kick 300,000 members in that state imageoff the program.  This is basically what is trying to happen here, so are we reforming healthcare?  Arizona just had to sell their Capital buildings to generate revenue so they too are not in a good spot.  

Arizona Medicaid Program Draws Fire – Governor Wants to Roll Back Part of Eligibility Increase – 1 out of 6 Residents are Enrolled But We Have Money for Football

I think in better economic times California may have sat in a better position but not today as all our businesses are also suffering.  I can agree here too with the number of doctors who do not take Medicaid as I hear it a lot, many do not take Medicaid as of today.  The fear is that even less will jump from the roles so where do we go from here?  Are we leaving out part of the equation here?  If more become eligible, who’s going to care for them?  Also in the news today we have Walgreens pulling out of Medicaid prescriptions in Washington due to low reimbursement rates. 

I think we have to do better than this and have true healthcare reform.  With transparency gaining momentum today with budgets, there’s no longer the ability to shift dollars from one area to another without it being known, in other words the sweetheart deals are out there for everyone to see.  We also still have some Medicare issues too with doctors opting out in that arena and many cardiologists will close up their offices with the Medicare cuts coming in, so there’s even a greater shortage coming in to play. 

American College of Cardiology Legal Suit – Judge Determines Federal Courts Can’t Review Medicare Physician Reimbursement Issues

As the governor stated last week, Nebraska got the corn and California is getting the husk.  The money and good times financially California enjoyed for many years has been impacted.  I don’t know why we keep hearing about the economy rebounding, the banks are which the US citizens financed, but where’s the rest of the deal for everyone else?  Frankly I’m tired of reading articles about the rebounding economy when it just is not there and healthcare is at the top of the list.  BD 

WASHINGTON – Paul Phinney is happy to be working as a pediatrician in Sacramento these days, with a historic health care bill on the horizon.

For starters, he says it'll be easier to treat patients if Congress makes it illegal for insurance companies to deny treatment for pre-existing conditions. imageAnd he says it would be good if those companies could no longer place a cap on how much they'll pay for medical services.

The program, known as Medi-Cal, currently serves roughly 6.5 million poor Californians. And that number could increase by 2 million under the pending legislation. Congress wants to use the Medicaid program as a way to cover more of the uninsured poor, reasoning that it's a relatively cheap way to go by relying on existing programs.

But doctors say only a third of the state's 60,000 practicing physicians are participating in the program because of low reimbursement rates, and they fear that more physicians will opt out.

"Increasing eligibility for Medi-Cal without increasing reimbursement rates would be catastrophic," said Brennan Cassidy, president of the 35,000-member California Medical Association. "There's no place for those patients to go for primary care because doctors aren't accepting them."

The politics surrounding the issue are getting a little tricky to follow: While Congress is considering swelling the ranks eligible for Medi-Cal, Schwarzenegger wants to limit eligibility as a way to save the state money.

While the federal government pays half the cost in California, the governor noted that it pays 75 percent in Mississippi and 65 percent in Arizona. Altogether, he said, 38 states have higher reimbursement rates than California, which in effect means the Golden State's residents "are subsidizing the Medicaid program" in those other states.

"There's much that's very good in the bill," he said. "And I think that having people go into bankruptcy over health care costs is unconscionable in a country like ours. We can do better than that. All of us want something to happen."

Doctors fear health overhaul may backfire for poor on Medi-Cal - Sacramento Politics - California Politics | Sacramento Bee

Cisco Systems and Molina Healthcare HMO Announce Telemedicine Pilot Program – Long Beach, California

I caught wind of this today earlier with a tweet and picture on Twitter from our Governor.  I wonder how many other states have a governor that uses Twitter?  imageGetting back on track here, this is a pilot program with Molina Healthcare, headquartered in Long Beach, California.  

Cisco Systems has contributed 10 million to the project whereby 15 sites will be able to offer video, audio and medical information via the internet and be close to having an in person visit.  Cisco also has a couple vans that are traveling all over the US and there’s a video below that tells the story on what technology is there both with mobile and other technologies. 

In past posts I have also posted about United Healthcare and their millions they have invested with Cisco for their telehealth project. 

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From the Molina Website:

“Working as an emergency room physician, in 1980, Dr. Molina realized that the needs of the less fortunate were being underserved. He opened a clinic in Long Beach, California where he cared for patients regardless of their ability to pay.

Over the years, Molina Healthcare has expanded this legacy. Our coverage now includes ten states across the country. Over 1.2 million people who depend on government assistance for their healthcare trust the quality and affordability of Molina Healthcare's Medicaid and Medicare plans.”

Cisco and Healthcare Technology – Hospitalist Avatar And Other Technologies On Display 

For the demonstration a physician conducted a visit with a patient over 500 miles away.  BD 

Doctor house calls may be a thing of the past, but these days, doctors and patients can interact with a 21st century twist.

On Friday, Gov. Arnold Schwarzenegger joined networking giant Cisco Systems and Long Beach-based Molina Healthcare Inc. as they announced a telemedicine pilot program which, when fully in place, will allow a patient to be seen by a specialist hundreds of miles away.

Partnered with Molina, two community health centers in San Diego and the state of California, Cisco will help provide health and wellness services to underserved communities throughout the state.

According to John Chambers, Cisco's chairman and chief executive officer, the technology will allow patients, such as the elderly, to be seen in the comfort of their own home, cutting down on the many different locations of doctor visits.

More than 15 sites will be equipped to deliver telemedicine primary and specialty care services using Cisco HealthPresence. All sites are expected to be fully operational within six months of Friday's announcement.

During the demonstration at the news conference, the doctor was able to examine a patient in Sacramento, some 500 miles away. He examined her eyes, a skin lesion and listened to her heart. Her vital signs were sent to the doctor electronically.

A new way to see your doctor - ContraCostaTimes.com

Related Reading:

Verizon Telehealth Service Teams Up with Cisco – Video Consultations Unveiled

The Medical Quack: Cisco's Vision of the Future – Video Showing ...

The Medical Quack: Cisco Investments in Healthcare – Mobile ...

The Medical Quack: Cisco and Healthcare Technology – Hospitalist ...

Cisco’s Vision of the Future – Video Showing Virtual Assistants and Microsoft Surface With Healthcare

This shows some very neat technology.  First of all we have the virtual assistant, which I have talked about before on the blog. 

Microsoft Does Talking Heads – The Virtual Assistant

Cisco and Healthcare Technology – Hospitalist Avatar And Other Technologies On Display

The video is pretty cool starting with the virtual assistant “clearing the glass”. 

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If you have not read up, check the link out below and see how many millions United Healthcare has invested with Cisco.

UnitedHealth To Spend Tens of Million of Dollars with Cisco to Build Nationwide Telehealth Network

image 

I like the use of Surface in here too with the 2 prescriptions on the table and Surface detects an adverse reaction.  This is not too far off and Moore’s law seems to be barking right at the door.  BD 

Cisco's vision of the future - Video - Technology

No Dignity Left with Death in Haiti - Many Will Never If Loved Ones Survived Or Where They Have Been Buried

This from Anderson Cooper at CNN and will make you sad and should make you thankful for where you are by comparison.  They are using bulldozers and burying people in mass graves.  He says the stench is heavy with the temperature over 80 degrees and if left on the streets, disease sets in.  This is just so sad and horrific. 

 

In addition he goes through the prison which was destroyed.  The UN thinks the prisoners rioted after the quake and escaped for the most part.  He talks with the warden of the prison and about the danger of them being back on the streets. 

Anderson Cooper 360: Blog Archive - Video: Mass graves in Haiti « - Blogs from CNN.com

Biologic Drugs – Obama Pushing for a Last Minute Change in Final Healthcare Bill To Reduce Patent Coverage

I can see both sides of this with the demand for cheaper drugs and the need for the company who developed them to be protected so they can recoup their expenses.  We have couple other issues involved here too in the fact that producing a drug due to technology may not take as much time as it did before.  The reason for this is technology and modular algorithms in genomics for one example, so 10 year protection is a long time, especially when you have insurance companies that wont pay many of them, bad when it comes to cancer drugs.image

On the other hand there’s been a lot of research and development to get all biotech drugs to where they are today and I mean years in that respect, and now we are seeing more and more of knowledge being shared too as to go back and start from scratch is like impossible.  It would be like Microsoft dumping everything they have developed and starting with brand new code, it’s not going to happen by any shape or form.  Just as software companies share and rely on research from other firms, so does biotech.  They are not starting from scratch and there’s a lot to build on here.  Based on how this is done today, 12 years is way too long for a patent to work with current economical conditions and should be shortened.  Those days are gone!

Look at where we are with the other side of the coin with generics, different from biotech drugs.  We have legal suits all over the place challenging patents to enable generic drugs to get to the market sooner and all kinds of “sweetheart” deals made there too.  Teva is certainly the king of lawsuits in order to get their generic equivalents out there.  Reducing this time frame only makes sense as the “glory” days are gone.

Now we have FTC involved in exploring those “sweetheart” deals too.

Generic Drug Deals – One More Area Being Explored to Help Reduce Cost of Healthcare by the FTC

Everything else in the world is selling for less today and granted pharmaceuticals have a captive audience by all means as we need cures and treatments.  Biotech drugs also face a difficult task with many of the big pharma companies not carrying the expense of R and D as well, they farm it out to start ups for one, so if they fail, no skin off of their back, or money down the drain; however, when trials start looking good, big pharma will rush right back in if there’s a chance to make a buck here.  I write about this stuff all the time here and you can search and find relative posts about this topic. 

The Medical Quack: Here Come the Bio Similar Drugs – Bill in ...

From a patient’s perspective, it makes no difference if the drug I or someone else is taking is biotech in composition or molecular, it’s just what we need for our treatments and cures, so if perhaps pharma and biotech began to perhaps see this how the consumer views it, perhaps we might see a few different opinions arise, as again as we are constantly “scored” by insurance companies and assessed with behavioral algorithms that are harder to fit, well do you think they are going to roll over and pay big bucks here, it’s already a problem as I have seen some treatments declared investigational that have been FDA approved for years, but it’s an avenue to give a “text explanation” for denying coverage or a claim.  Help keep healthcare affordable and go with the flow, the big profit days are growing slimmer all the time.  BD 

President Obama is pushing for a last-minute change in the final health care bill that would shorten the time that expensive biotechnology drugs would be shielded from generic competition, pharmaceutical industry officials said Thursday.

Any White House intervention would be welcome news to generic pharmaceutical companies, as well as to some consumer groups, insurers and big employers, which have complained that the proposed House and Senate bills would not allow for robust competition.

Both the House and Senate bills would for the first time create rules by which so-called biologic drugs, which are made in living cells, would be subject to copycat competition, saving the health care system billions of dollars over 10 years.

To retain incentives for innovation, both the House and Senate bills would provide a brand-name biologic drug with 12 years of protection from competition, even if the drug’s patents expire before that.

Biologic Drugs May Get Less Protection - Prescriptions Blog - NYTimes.com

Arizona Medicaid Program Draws Fire – Governor Wants to Roll Back Part of Eligibility Increase – 1 out of 6 Residents are Enrolled But We Have Money for Football

Once more budget cuts are causing the system in Arizona to not have enough money.  It’s election time though and the Governor is trying to make a statement, politics and healthcare again, same old story, but doesn’t help get healthcare to those who need it.  The proposed change would affect 300,000 people and basically knock them off, sounds like what some insurers are doing, knocking off the non profitable like Aetna announced this year when eliminating over 600,000 of their current insured.  image

One other item of interest though, the Governor called for Arizona like many other states to join in and fight the legality of the Nebraska deal.  Our governor in California said the same and finished with “they got the corn and we got the husk”.  Arizona has been in dire straights with budgets to even having to sell and rent back state government buildings, and earlier this year the big expensive stadium where football is played almost did not afford opening, but gee it is football and someone found some money to do that, so it appears football reins above healthcare in Arizona.  I am from Arizona and spent a few years working in their State Government so nothing much surprises me there.  BD 

Arizona's Medicaid program has become both a budget headache and a political football, with its costly burgeoning enrollment and the possibility that national health care legislation will add even more red ink on the deficit-plagued state's bottom line.

Enrollment in the Arizona Health Care Cost Containment Program has soared in the past decade, thanks to the recession and an earlier voter-mandated lowering of income eligibility thresholds.

Only when its counties were bowing under the burden of providing health care for indigents did Arizona in 1982 become the last state to join Medicaid, which was created in 1965.

Arizona Health Program Drains Cash, Stirs Debate - ABC News

Omnicare, Johnson & Johnson, Risperdal, Whistleblowers and Legal Woes Back in the News Again

This has not been a good day for J and J today.  In addition to the Tylenol recall, another case investigating marketing and kickbacks in now in the courts.  Omnicare is no stranger to kick backs and it was just in November they admitted no wrong doing, but kicked out close to 100 million in money to settle the issue.  What is this any more, nobody admits to any wrong doing and they just keep throwing money at problems and issues that may entail big time wrong doing?  image

How much longer are the deep pockets of pharma and other entities going to hold out?  It could be a while as they all sit on a ton of money, but like everything else in the world, the big pockets seem to be getting smaller, or maybe it’s just the amount that is dug out of the pockets is the tilting point here.  Here’s what was posted in November and there’s an additional video at the link. 

Omnicare Agrees to Pay Close to $100 Million To Settle Case with Justice Department – Paying and Receiving Kickbacks From Ivax and Johnson and Johnson

“One of the companies accused in the case of providing kickbacks was Johnson and Johnson in their marketing of Risperdal.  In addition $8 million in kickbacks from drug manufacturer IVAX in exchange for an agreement to purchase $50 million dollars worth of drugs.  With Risperdal coming off of patent that somewhat will make less expensive generics available for seniors.”

Psych drugs are a hot topic anywhere today too so again with technology and tracing back audit trails and perhaps videos and other material used in marketing of days past we have information to trace some of this, what a novel approach, technology helping with transparency. 

I had somebody the other day pose the question about how doctors get all their information relative to healthcare, devices and so on.  With drugs and device companies it’s like any other business, from the sales and marketing departments. One other item worth a short note is that in June of 2008, generic Risperdal hit the shelves, so competition after that time was alive and well.   I keep repeating this past post so many times but gosh it just seems to apply when it comes to dollars being made in healthcare today, those algos and whistleblowers generate a lot of money.  BD

The Two Hot Words in Healthcare today Whistleblowers and Algorithms

BOSTON (AP) — Federal prosecutors in Boston said Friday that health care giant Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia drug.

In a complaint filed Friday in Boston, prosecutors said J&J paid the kickbacks, in the form of special rebates and other payments, to Omnicare, the country's biggest dispenser of prescription drugs in nursing homes. Prosecutors allege Omnicare pharmacists then recommended that nursing home patients with signs of Alzheimer's disease be put on the powerful schizophrenia drug Risperdal.

"Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving," U.S. Attorney Carmen Ortiz said in a statement. "Nursing home doctors should be able to rely on the integrity of the recommendations they receive from pharmacists, and those recommendations should not be a product of money that a drug company is paying to the pharmacy."

Besides Johnson & Johnson, the complaint names two of its subsidiaries as defendants: Ortho-McNeil-Janssen Pharmaceuticals, which makes and sells Risperdal and other drugs, and Johnson & Johnson Health Care Systems, which entered into contracts with Omnicare.

U.S. Attorney: Johnson & Johnson paid kickbacks to boost sales - USATODAY.com

US Navy Hospital Ship “Comfort” Staffing and Moving Out to Haiti For Additional Medical Care

The US Navy Hospital ship is docked in Baltimore and when not in service only carries a very limited crew, thus a bit of a delay to get the ship rolling.  It plans to take imageoff this weekend full staffed with a crew of 900.  People will be airlifted to the ship for care. 

It will take the ship about three and a half days to reach Haiti once it sets sail.  The ship is fully set up to do CAT scans, X-Rays and surgeries.   Doctors without Borders are also setting up inflatable hospitals to help.  I heard on the news last evening some very disturbing accountings that “bodies” are being used to create roadblocks. With things beginning to get a little more anxious and put yourself in the same situation, all news accountings say the Haitians have been extremely patient and cooperative.  CNN also stated one other item that was a bit unsoothing in the fact that bulldozers were being used to move bodies?    Donate and help the cause by all means and that last statement is more than enough to see why help is so badly needed.  BD 

No Hospitals Remain in Port-au-Prince Haiti All Collapsed or Are Abandoned – Inflatable Hospitals Are On the Way

 

BALTIMORE -- The flurry of activity on Pier 11 in Baltimore began Thursday, as the USNS Comfort prepared for its latest mission -- to aid in the relief effort following Tuesday's massive earthquake in Haiti.

The 894-foot-long ship, described as a "floating hospital," holds a trauma facility equipped to treat up to 1,000 patients at a time. Haitian patients are expected to be transported aboard by helicopter.

Inside, the ship holds many of the trappings of a landlocked hospital. Its lime-green halls are filled with gurneys and operating tables. It also carries X-ray machines, neonatal incubators and a CAT scan unit.

Heather Pulliam, the Comfort's assistant lead petty officer for nursing services, said her husband, a Baltimore police officer, gave her some blunt advice on how to deal with the tragedy once she arrives.

"Pretty much, suck it up," said Pulliam.

Navy hospital ship Comfort prepares to aid Haitian quake victims | World News - cleveland.com -

Does Your Tylenol Stink? Maybe It Has Been Recalled As The List Has Grown Today

Once again the product lots have been expanded, so simple rule of thumb is if you open the bottle and it stinks, don’t take the pills.  Nobody has died from any of this, but there are reports of some having nausea related symptoms.  Below is a short recap of what was released in late December on the recall. 

Tylenol Arthritis Formula Recall Expanded to All Product Lots with Red EZ-Open Cap – Johnson and Johnson

The reason for the recall is a chemical that is used to treat shipping pallets and perhaps some of the chemical, vapor, etc. has been captured in the bottles.  This is what appears to be the story here as the bottles contain a “foul” smell.  The chemical has the capability to ruin the medication as well as bring on some nausea, imagevomiting and diarrhea. 

More information about the FDA recall can be found at: here  Additional information can also be found here.  Regular Tylenol is still ok and the recall is for the specific “Arthritis” formula.  BD 

NEW YORK -- Johnson & Johnson expanded a recall of over-the-counter medications Friday, the second time it has done so in less than a month because of a moldy smell that has made users sick.
The broadening recall now includes some batches of regular and extra-strength Tylenol children's Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph's aspirin. Caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji were recalled.

A full list of the recalled products is online at www.mcneilproductrecall.com.

Johnson & Johnson expands Tylenol recall - latimes.com

ScrubsGallery.com – January Reader Discount

Again, I thank ScrubsGallery.com for advertising with the Medical Quack. 

This month they are offering a discount on Hello Kitty Scrubs with the special code below.  BD 

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For a limited time, you can get a 15%  with Hello Kitty Scrubs by using the code “helloduck” on your order!

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Next time you need to order scrubs or other healthcare apparel, please check out their website and compare. 

Thanks again to ScrubsGallery.Com for supporting the Medical Quack!!

Whistleblower Off Label Marketing Law Suit – Stents Marketed and Implanted To Treat Blocked Blood Vessels But Were Made To Be Implanted in the Digestive Tract To Treat Cancer

If you read any on stents these days, you will know there are a lot of them around and very specifically made for certain area of the body and treatments, everything is this way today, drugs included with gnomically based and created medications.  Cancer drugs are a perfect example and why tests are being researched and created to find the “cancer of the unknown” which makes every difference in the world as to the selection of drug used for treatment and now we have off label allegations in medical devices too. 

The article states that over one million stents were used “off label” from 2003 to 2006 to open clogged blood vessels in other areas of the body, and the report included deaths and injuries occurred as a result of a malfunction of the device.  When you get into stents, they are very specific and for a very simple example, blood flow varies and you would not want a stent that was made to handle lower levels of blood flow in an area of the body where there is more pressure.  Vascular stents need more durability for a quick explanation. 

Just from writing this blog and conducting some interviews, by osmosis I have a little bit of knowledge here about stents.  I did an interview with Cook Medical and one item I learned about leg therapies is that this type of stent needs special design when placed in a leg, why?  Because it moves and with a heart, well you can tell the difference right there, the heart stays in one place, legs do not, thus extra time and trials for a stent that is going to not move and continue to provide blood flow when the legs are moving.  The stents in the legs were supported with micro wires.  At the bottom of this post are several interviews/articles where I was educated on stents by Cook Medical and worth a read, to include talking with Dr. Bart Muhs, Head of interventional surgery at Yale University.

I also learned that some of the pre-medicated stents also use a cancer drug, that is legal and FDA approved for use with placement of a stent as it helps with rejection with the body, so when you think about it, perhaps due to the fact that the impregnated stent had this drug embedded, it somehow was used off label?  That part is just a guess from me. 

I would guess if they were implanted, autopsies from deaths and inspection of patients who have the stents implanted would be in order to investigate. 

Be the informed patient today and ask questions – know your stent!

  Here’s that same post that has been floating around this blog for 2 years and still appears to be true, algorithms and whistleblowers, 2 big items that generate money in healthcare.  BD

"The New Hot Words in Healthcare Algorithms and Whistleblowers”

A former medical device executive claimed in a potential whistle-blower lawsuit that was unsealed this week that the makers of stents approved to treat digestive tract cancers had illegally marketed them for years to treat blocked blood vessels in other parts of the body.

In the lawsuit, Kevin N. Colquitt, a former regional sales director for Guidant, stated that he had been trained to market the devices, which are known as biliary stents, to doctors for off-label uses not approved by the Food and Drug Administration.

Along with Guidant and Abbott, which acquired Guidant’s stent operations, the other defendants in the lawsuit are Boston Scientific and Cordis, a division of Johnson & Johnson. A spokesman for Abbott disputed the lawsuit’s accusations. Spokesmen for Cordis and Boston Scientific declined to comment on the suit’s specifics.

Suit Says Makers Marketed Stents for Unapproved Uses - NYTimes.com

Related Cook Reading:

Cook Medical Announces FDA Clearance for Advance® 35LP PTA Balloon Dilatation Catheter - PVD

Cook Medical Unveils MicroWires to support Leg Therapy - Peripheral Arterial Disease

Catheter-Related Bloodstream Infections - Interview
Heart valves implanted without having open-heart surgery
Cook Medical Announced the new Strategic Business Unit – Interventional Radiology
Cook Medical Unveils MicroWires to support Leg Therapy - Peripheral Arterial Disease
Interview with Bart E. Muhs, M.D., Yale School of Medicine – Aneurysm Repair Surgery
Catheter-Related Bloodstream Infections – Interview

US Banks and Companies Donate to Haiti – Banks Should Give More and Hold Down Bonuses

In reading this article in Bloomberg, one million seems to be the rounded number, although Jeffries is adding to the till with donating all commissions for a day and volunteered salaries.  Also below is a listing from Reuters from a few more companies, Wells Fargo looks cheap by comparison at $100,000 so maybe this will shame them into contributing a little more when you see companies like Go Daddy chipping in a half a million.

Walmart set up a site to encourage additional contributions.  The cell phone donation works really well and is simple to do.  I hope all the dollars get there.  BD 

Jan. 14 (Bloomberg) -- Jefferies Group Inc., Morgan Stanley and Goldman Sachs Group Inc. each pledged at least $1 million for relief efforts following the Haiti earthquake, among many U.S. and European businesses offering aid to victims.

JPMorgan Chase & Co., Bank of America Corp., American Express Co., Visa Inc. Amgen Inc., United Parcel Service Inc. Lowe’s Cos., Wells Fargo & Co., Eli Lilly and Co., Walt Disney Co., Western Union Co., France’s Credit Agricole SA and Britain’s Tesco Plc were among others that announced donations.

Go Daddy Group, a Scottsdale, Arizona, concern that provides Web site design and registration, sent a $500,000 check to Hope for Haiti, a nonprofit organization that supports education and health care in the country.

Jefferies will donate all net commissions tomorrow, and volunteered salaries, plus $1 million. In October 2001, it raised $6 million for Sept. 11 relief; $3 million for victims of the Asia tsunami in 2005, and later that year, $2.5 million following Hurricane Katrina.

Jefferies, Ackman, Morgan Stanley Pledge Haiti Aid (Update2) - Bloomberg.com

Target Corp will donate $500,000 to the American Red Cross to assist with disaster recovery in Haiti.
- Procter & Gamble Co said it will provide at least 2 million packets of PUR Purifier of Water through our Children's Safe Drinking Water partners. It said Duracell has already provided $200,000 worth of batteries and flashlights for donation.
- National Bank of Canada will contribute up to C$250,000 to the Canadian Red Cross. National Bank MasterCard cardholders can exchange reward points, free of charge, for a cash donation to the Canadian Red Cross by calling 514-847-8280 or 1-800-341-8083.
- The New York Yankees will donate $500,000 in support of rescue and relief efforts.

http://www.reuters.com/article/americasCrisis/idUSSGE60D0IB

Partners in Health Hospital Beginning to Treat Patients in the Town of Hinche in Haiti

Partners in Health in Boston also was set up in Haiti, and their facility is not in Port-au-Prince where all the major damage took place, so citizens are starting to make their way to outlying facilities.   You can read more on the website about their past and present efforts in Haiti.  You may be familiar with Partners in Health as imagewell though their Health IT models and other offerings.

Partners in Care is also one of the non profit agencies where you can send a donation.  Partners in Health has been active in Haiti for over 20 years and operates a full service hospital with over 120 doctors in Hinche.  BD 

From the rubble of the devastated Haitian capital Port-au-Prince, the injured are making their way slowly to outlying hospitals and clinics run by Partners in Health, according to a spokesman with the Boston-based international health agency.

"People have started to arrive," Partners in Health spokesman Andrew Marx said this afternoon from the agency's Boston headquarters. "Some of them are getting there on their own. There has been more than a trickle of people coming in."

At the Partners in Health hospital in the town of Hinche, workers loaded a truck with medical supplies and prepared to make the two-and-a-half-hour journey to Port-au-Prince. The need, they learned from a colleague in the capital city, is acute.  What is less certain, he said, is the safety of workers' relatives. "Many of them have not been able to determine the whereabouts and well-being of their family members," Marx said, "and obviously that's a huge concern." The Partners in Health model -- established in Haiti and later expanded to Peru, Russia, several African nations, and the United States -- depends on developing a local workforce.

Injured begin to arrive at Partners in Health hospitals in Haiti - White Coat Notes - Boston.com

Pfizer To Continue MAINTAIN Patient Assistance Program for an Additional Year – Medications Free for the Unemployed

Pfizer was gracious enough to make this offer last year and it continues on for one more year so if you are unemployed, find out about the program if you need help with medications.  Also this year they are adding on many of the Wyeth medications on the market too, so it gets a little better this year.  image

Pfizer to Offer Free Drugs for Up to a Year for those who have lost Jobs and Insurance – Save that Pink Slip

There are over 70 in the list, but many already have generic equivalents, so I would guess those who do not have a generic equivalent might be the hottest on the list and perhaps the first in demand.   The article says you will need to show proof with a “pink slip” to show that you have in fact lost your job too.  BD 

As everyone commented last year, Viagra is included.  If you don’t think that is a big deal, read this and see the cost.

The Medical Quack: What Does Viagra Cost?

Pfizer also thinks you should know where your pills come from, interesting commercial.  BD 

NEW YORK--(BUSINESS WIRE)--Pfizer today announced it will extend its MAINTAIN (Medicines Assistance for Those who Are in Need) patient assistance program for an additional year, through December 31, 2010. In addition to the more than 70 Pfizer primary care medicines currently available through MAINTAIN, Pfizer will extend the benefits of MAINTAIN to many legacy Wyeth medicines.

Pfizer launched MAINTAIN in May to help unemployed and uninsured Americans stay on their Pfizer medicines. The program, an employee-driven initiative, is part of Pfizer Helpful Answers®, Pfizer’s family of patient assistance programs that helps uninsured and underinsured Americans get Pfizer medicines for free or at a savings. Seventy-five percent of people who have applied to Pfizer’s MAINTAIN program have been enrolled.

Coupled with testimonials from MAINTAIN members and other interactive features, Pfizer released the MAINTAIN widget, an online tool that guides users through a short series of questions that determine whether they may be eligible for MAINTAIN or for another Pfizer patient assistance program.

Press Releases | Pfizer: the world's largest research-based pharmaceutical company

FDA Approves Stem Cell Therapy to Treat Lou Gehrig’s Disease

TCA Cellular Therapy in Covington will be conducting the trial, which will use a patient’s own stem cells.  As mentioned, this is the 2nd FDA approved trial for the disease using stem cells.  BD

COVINGTON, La.--(BUSINESS WIRE)--TCA Cellular Therapy, LLC (TCA-CT) announced today that the U.S. Food and Drug Administration (FDA) has approved imageits adult stem cell protocol to conduct Phase I clinical trials to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease).

This is the second FDA-approved protocol for the treatment of ALS using stem cells in the country; and the first using adult stem cells from the same patient. The aim of the Phase I study will assess safety.  

“I hope that our trial, along with the combined efforts of scientists and patients, will pave the way to breaking the chains of this devastating disease,” stated Gabriel Lasala, M.D., president and CEO of TCA Cellular Therapy.

About the Trial

Under the scientific guidance of cellular biologist, Jose J. Minguell, Ph.D., the adult stem cells will be taken from the patient’s bone marrow in a simple outpatient procedure. The cells will then be processed in TCA-CT’s GMP laboratory and administered to the patient by spinal tap in one of TCA-CT’s facilities.

Recruitment for trial patients will commence in the next few weeks. The company anticipates moving into Phase II within a year.

About TCA Cellular Therapy

TCA Cellular Therapy, a privately-held company located in Covington, Louisiana, has assembled a team of neurologists, neurosurgeons, cell biologists, and pathologists to study some of the most debilitating neurological diseases including ALS and Spinal Cord Injuries.

FDA Gives TCA Cellular Therapy Green Light to Proceed with First ALS Adult Stem Cell Trial Using Patient’s Own Stem Cells | Business Wire

Quest Diagnostics Offers New DNA Test to Aid in Detection of Colorectal Cancer

Quest is the first lab to offer the laboratory test based on the Septin9 marker.  The test is called the “ColoVantage” test and is not considered a screening test but patients may consider the test as it is less evasive than some of the current tests. 

In other related Quest news, one of their employees participated on the TV show “The Biggest Loser” so he’s serving to set an example for other in the company for losing weight.  BD 

A new blood test that identifies changes in DNA associated with colorectal cancer is now available in the U.S. through Quest Diagnostics Incorporated (NYSE: DGX). The test is designed to aid the detection of colorectal cancer, the third leading cause of cancer-related deaths.
The new test is based on DNA methylation of the Septin9 gene, a proprietary biomarker associated with colorectal cancer that was identified by Epigenomics AG, a cancer molecular diagnostics company. Quest Diagnostics is the first commercial laboratory in the U.S. to offer a laboratory-developed test based on the Septin9 biomarker.

The new test is based on DNA methylation of the Septin9 gene, a proprietary biomarker associated with colorectal cancer that was identified by Epigenomics AG, a cancer molecular diagnostics company. Quest Diagnostics is the first commercial laboratory in the U.S. to offer a laboratory-developed test based on the Septin9 biomarker.
"Early detection rates are dismally low, largely because many patients find existing tests and procedures invasive or unpleasant," said Jon R. Cohen, M.D. senior vice president and chief medical officer, Quest Diagnostics. "Our ColoVantage™ test, which is based on Septin9, has yet to be clinically validated as a screening test. Rather, it may promote further evaluation in patients who have resisted testing in the past or as an adjunct to existing procedures."

StreetInsider.com - Quest Diagnostics (DGX) Brings Colorectal Cancer DNA Change Blood Test to U.S. Market

Amish and Other Religious Groups Exempt from Health Insurance Provisions in Both House and Senate Bills

As healthcare reform moves on, will religion become an issue?  There are a few groups in Massachusetts that are exempt.  This is one more reason why penalties won’t work.  We also have provisions for the IRS to potentially police the health insurance area through tax returns.  image

As the article states the exemptions call on some very specific language and groups have to be non-profit as well.  The Amish and Mennonite groups are small by comparison to the population of the entire country but it will be interesting to see now with the way the economy is, to see if these exceptions fly without voices from others wanting the same, you know, kind of like what Nebraska received.   As our Governor said in California, they got the corn and we got the husk. 

Opting Out – Mennonites and Amish Face rising hospital bills

Now they have genetics research going on within the communities to help save their children who have high rates of some rare genetic diseases.  It is far fetched to even think the communities would travel abroad for help.  Dr. Morton has moved in to the community to help. 

THEY HAVE GENE SEQUENCING MACHINES – so the citizens are contributing to research and development with the study of some genetic diseases and family history items that seem to occur only in their communities.  BD

Right now with the focus on transparency, it’s not easy to roll anything under the carpet and hope it won’t be noticed anymore.  Technology and data methodologies of communication make certain that doesn’t happen any more as well as uncovering more of this that has already occurred in the past.  BD 

Since the 1930’s, the Amish have been exempt from paying Social Security taxes. The Watertown Daily Times, which is from a region of northern New York that many Amish families call home, notes that under Congress’s health care bills, the Amish would also get an exemption from the mandate to have “acceptable” health insurance or pay a tax penalty if you don’t.

Federal health care reform will require most Northern New Yorkers — but not all, it turns out — to carry health insurance or risk a fine.
Hundreds of Amish families in the region are likely to be free from that requirement.
The Amish, as well as some other religious sects, are covered by a “religious conscience” exemption, which allows people with religious objections to insurance to opt out of the mandate. It is in both the House and Senate versions of the bill, making its appearance in the final version routine unless there are last-minute objections.

The language is very limiting. Christian Scientists, for example, would not be eligible for the exemption because they are not conscientiously opposed to having health insurance. “Some [Christian Scientists] have health insurance, and most probably have life insurance,” says the FAQ page of the official CS church website. “Every Christian Scientist makes his or her own financial and health decisions.” It’s limited essentially to the Amish and Old Order Mennonites

Amish and Other Religious Groups Exempted from the Individual Mandate - Blog - OpenCongress

No Hospitals Remain in Port-au-Prince Haiti All Collapsed or Are Abandoned – Inflatable Hospitals Are On the Way

According to this article, their hospital care had no real emergency services as we would expect here in the US.  I was watching the news and everybody is outside as they are afraid to re-enter structures as they are still experiencing after shocks.  I live here in California and unfortunately I know earthquakes and aftershocks and they have it so much worse in Haiti. 

In another related article, Doctors without Borders is ready to set the inflatable hospitals and they have done this in several disaster areas.   image

“Doctors Without Borders has been employing them for years, including an impressive inflatable nine-tent, 120-bed center in Pakistan following a 7.6 magnitude earthquake there in 2005. The hospital post-and-beam frames can be made from the same fabric in inflatable lifeboats. Nylon interior and exterior walls leave space for air to create an insulating effect. The Cleveland Plain Dealer created an infographic showing one kind of inflatable hospital.”

Even the Red Cross building collapsed so they were also improvising.  Malaria is also a big concern here and with open sewers and lack of water, disease stands to be a huge problem as each day moves on. 

Even before the 7.0 earthquake that is believed to have killed thousands of people and crushed countless buildings, the medical infrastructure in Haiti was already almost nonexistent.

While the primary focus of the next 72 hours is rescue and saving lives, officials say, aid workers are facing countless critical medical needs for the millions who have been affected by the widespread destruction.

What are the immediate medical concerns facing rescue workers?
Today we learned from Doctors Without Borders that there are no hospitals remaining in Port-au-Prince. All hospitals are either collapsed or abandoned, including the three run by the aid group.

According to Doctors Without Borders, there are enormous lines of people outside of these closed facilities, many with severe injuries, including fractured bones and crushed skulls waiting for treatment. But there's no medical treatment happening because the area has absolutely no facilities. Even before, the hospitals that existed had almost nothing that we would consider an intensive care unit. And Haiti has no system of frontline responders to rescue and revive people in emergencies.

Further down the road, Haitians will also likely suffer from secondary infections. With hospitals and clinics destroyed, people seeking help for broken bones and other survivable injuries will not be able to get help and will develop complications.

Bazell: Earthquake worsens health nightmare - Haiti earthquake- msnbc.com

Walgreen Pilot Program – Consultation with the Pharmacist Who Sends Meeting Details to Primary MD

There’s no mention on how the information gets back to the Primary MD, and with many not being on electronic records, I’m guessing either a phone conversation or fax will be the method.  This is being conducted in a limited area.  image

People with Type 2 diabetes will have an opportunity for personal consultations with Walgreen Co. pharmacists and nurse practitioners under a pilot program set to be announced Wednesday.  This is free for the patient for now; however if it works well patients may end up paying a fee if it goes national in agreement with their health insurance plan.  This is all about compliance here and taking your medications.   This has been one big focus because if it’s not devices, they are working on some other angle to drive patients to take their medications, that is when they can afford them. 

In other Walgreen news they are protesting the state Medicaid payments.  I seem to remember that Ingenix has a contract with the state to help catch fraud and we all know what happens when algorithmic scoring takes place, maybe this had something to do with reimbursement rates here too.  We know they are the king of healthcare algorithms.  BD 

State of Washington award contract to Ingenix, subsidiary of United Healthcare for Medicaid Fraud control

Enrollees in the program, operating in Indianapolis, Oklahoma City, Phoenix and Albuquerque, N.M., will be able to discuss medications, weight and other issues in a one-on-one consultation with a Walgreen employee. After each consultation, pharmacists will contact the patient's primary physician with details from the meeting, Walgreen said. Participants also will meet about four times a year for sessions on issues like nutrition and glucose monitoring.

Walgreen to Test Diabetes Services - WSJ.com

Human Like Algorithms Need to be Developed For Artificial Pancreas – Johnson and Johnson To Develop

Once again we return to the software issues, the algorithms, and who thinks these don’t shape the world today.  Good choice with Johnson and Johnson to develop and work on the project.  The device would have 2 working parts, but the tricky part is the human side, in other words to have the functionality of no human intervention, but rather functioning independently and releasing insulin as needed.  image

Not too long ago I did an interview with a company that provides a web based application to share and brainstorm without divulging Intelligent Property called E-Zassi, so who knows, this may be one of the tools Johnson and Johnson might use to find their software partner(s).  People like Medtronic uses software as such to find their matches as well.  BD 

E-Zassi Introduces Online US FDA Regulatory Calculator – Medical Device Assessment

The Juvenile Diabetes Research Foundation said it had chosen Johnson & Johnson unit Animas to develop and test the new system.

"This is going to be a research and development first step, toward creating an artificial pancreas," Dr. Henry Anhalt, director of medical affairs for Animas, told Reuters in a telephone interview.

image

Animas, which makes insulin pumps, will work with the foundation to create a wireless system combining continuous glucose monitoring devices, insulin pumps, and sophisticated software to free diabetics from the chore of constantly checking their blood and giving themselves insulin.

The goal would be a device that can check the blood throughout the day and deliver insulin as needed without the need for the patient or a parent to intervene.  "There is no one algorithm that is currently available that can deal with all contingencies in a patient," said Anholt, a pediatric endocrinologist.

Nonprofit, company team up for 'artificial pancreas' | Reuters