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Intel Sees Potential Growth through Investing in Healthcare

3/28/2009 11:02:00 PM  ,  

I agree, healthcare has a long way to go, but it is work in progress, and it’s not just the hospitals and doctors, it’s also government agencies like the FDA that are in there too.  From a post last year in reference to employees of the FDA not having computers and doing research on paper: 

“Hello Intel...anybody listening...maybe Craig Barrett...could we get some Classmates over there to help out??  BDimage

And then I read this…(from Congress last year)

“Some of our members don’t even use computers,” Olcott said. “They have some discomfort talking about technology.” ...so if this happens at the top levels...I do ask myself...where does this leave me?  They have staff that writes the legislation...so who's really in control here...do we need to lobby the staff instead?  What impact does this have on electronic medical records?  What does this do for HIPAA? ...some questions kicking around in my head..who is in charge?

And this…

Does Intel know about medical errors, well first hand Betty Moore, wife of Intel Co-Founder Gordon Moore was the victim of medical errors herself while in the hospital.  This lead to a big contribution lf 100 million to establish  a Nursing School in northern California. A nurse gave her a shot of insulin that was supposed to go to the patient in the next bed.

It comes down to business intelligence, something the banking business had made a living from.  There are some additional Intel related links below on some of their areas of technology and investments outside of the chip, like the car that drives itself, powered by a couple core 2 duo servers.  BD 

MEDELLIN, Colombia (Reuters) - Intel (INTC.O) is open to making acquisitions with weakening markets making prices more palatable, and sees technology's key growth areas in healthcare and visual media, outgoing chairman Craig Barrett said on Friday.

Barrett, who steps down in May after 35 years at the company, thinks healthcare should follow the lead of financial services companies, offering access to medical records any time or place around the globe.

"There is huge opportunity going forward in the area of health care. Health care is one of the industries which has really not embraced information technology to a large degree."

Intel still open to acquisitions amid slowdown: Barrett | Deals | Reuters

Related Reading:

Intel The Car Company – Could Happen and Perhaps a Good Idea as there’s a lot more to this story and technology

Intel Home Health Monitor PHS 5000 is here

FDA Approves Intel Home-Care Touch Screen Device
Medicine is a Low Tech Business - Clinical Studies still done on paper too!

Intel Capital to take $20M stake in Telligent Systems

Intel buys mobile Linux startup

Intel launches first medical device

Intel invests in genome-sequencing outfit - California

The Autonomous Car…Car Bots Will Save Lives

Family Caregivers Website from Intel

Intel's future tech for robots and health care

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GE Healthcare Penalized for False Advertising Campaign against Bracco Diagnostics

3/28/2009 09:32:00 PM  ,  

Part of the legal ruling requires that GE retrain their sales representatives and post a press release.  This was a 39 day trial.  It was one of the most  comprehensive examinations of false advertising claims in legal history.

The study went as far as the New England Journal of Medicine with the comparison, so here goes a little more journal history to question.  BD

Bracco Diagnostics Inc. (“Bracco”) announced today that the United States District Court in Trenton, New Jersey has ruled in favor of Bracco and against GE Healthcare in one of the most significant false advertising cases to date. Today’s ruling validates Bracco’s position that GE Healthcare and its predecessor companies, including Amersham, engaged in a false and misleading advertising and promotional campaign in an attempt to make false claims that its x-ray contrast agent Visipaque™ was superior to Bracco’s market-leading x-ray contrast agent Isovue®.  image

 

 

 

In its ruling, the Court found GE Healthcare liable for disseminating false messages in its advertising of Visipaque™. The litigation is primarily related to a clinical study that was published in 2003 by the New England Journal of Medicine (the NEPHRIC study) comparing two GE Healthcare products: Visipaque™ and Omnipaque®. While the study only compared these two GE Healthcare products, GE Healthcare misrepresented the study in an attempt to claim that Visipaque™ was safer than other products that were not included in the study, including Bracco’s Isovue®. In addition, independent studies, Bracco studies, and GE Healthcare’s own clinical research demonstrated the inappropriateness of GE Healthcare’s false claims. 

image

As a result of GE Healthcare’s misconduct, the Court permanently enjoined GE Healthcare from making further false claims and ordered them to implement a number of corrective actions, including a press release and advertisements, to ensure that healthcare providers are correctly informed about the false claims. The Court also ordered GE Healthcare to pay Bracco $11.4 million in damages.

News: Court Rules that GE Healthcare Engaged in False Advertising Campaign against Bracco Diagnostics.

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Health insurance to rise in Australia – Same Issues, Different Country but they do have the “Dole”

3/28/2009 08:51:00 PM  ,  

A couple months ago I posted on the serious issues of money also facing hospitals in Australia, so they appear to share the same failing business model we have for healthcare, but they do have the government who provides healthcare as a back up for those who do not have private health insurance.  Also, it appears some of the perhaps similar marketing models are in place with brokering and getting a commission for referrals for new enrollees.  One story said some of the hospitals were having to buy or borrow supplies from the local veterinarians.  BD 

THE timing couldn't be worse for many Australians already struggling to make ends meet. From April 1, about 10 million private health insurance customers will pay as much as 12 per cent more for their premiums.

The Federal Government has approved average increases of six per cent - equating to an extra $160 a year for a family's hospital and extras cover.

Experts say the price hikes will range between four and 12 per cent. 

But what if there was a way to buck the trend and make your premium go down?

One health-insurance comparison service says it can save people $1000 a year on their health insurance.

HelpMeChoose, a free online service, says average Australian families, couples or singles can save money by carefully examining what they want in their policies and excluding non-essential items.  It is a free service to consumers, but HelpMeChoose sometimes receives payment from its six participating health insurers for referrals.

Health insurance to rise | The Daily Telegraph

Related Reading:

Hospitals across Australia Dealing with Crisis Situation

Hospital 'gets supplies from local vet' – Australia

Premiums up as 750,000 ditch cover - Australia

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Senior Doctors: Drug allegations/convictions in the News

3/28/2009 08:35:00 PM  ,  

It appears tracking of narcotic prescription drugs is on the rise by police officials.  These were 3 different cases in 3 different locations this week.  The 4th article here involves a VA physician who didn’t keep adequate and/or fake records to get patients enrolled  in drug studies, of which we have been hearing quite a bit of in the news today about the accuracy and how they were conducted, as well completely duped records that were made up for the study reports.

What 3 of the doctors have in common is the fact that they are all over 75 years old, two in their 80s that were involved with over prescribing drugs and now are either facing time in jail and/or fines.  The one somewhat startling fact was the physician in Tampa who is 83, was called the top prescriber of narcotics in the state and was pretty much aware that he was being watched.  BD  image

A Colorado doctor accused of illegally prescribing anti-depressants to a Stanford student who later committed suicide has been convicted of practicing medicine in California without a license.

Christian Hageseth, 76, faces up to a year in county jail, San Mateo County Chief Deputy District Attorney Steve Wagstaffe said.

Hageseth had entered a surprise no-contest plea to the felony charge on Feb. 24 in San Mateo County Superior Court.

Hageseth prescribed fluoxetine hydrochloride, a generic form of the anti-depressant Prozac, over the Internet to John McKay, a 19-year-old Stanford student and Menlo Park resident in June 2005. Two months later McKay committed suicide by carbon monoxide poisoning, inhaling car-exhaust fumes at his mother's home.

Palo Alto Online : Doctor convicted in Internet prescriptions case

TAMPA — Dr. John Rew prescribed so many painkillers that he believed police were watching him.

He was right.

On Tuesday, federal marshals arrested the 83-year-old doctor, who last year told the St. Petersburg Times that a Drug Enforcement Administration agent had called him the state's top prescriber of narcotic

http://www.tampabay.com/news/courts/criminal/article986795.ece

NEWPORT NEWS - An 82-year-old Newport News doctor pleaded guilty in federal court Friday to unlawfully distributing drugs, in connection with 700 prescriptions he wrote between January 2007 and March 2008.
Dr. Lawrence S. Cowling, who worked as an independent physician at several medical facilities in Newport News, holds a Drug Enforcement Administration registration allowing him to write prescriptions for methadone and other drugs, a U.S. Attorney's Office press statement said.

http://www.dailypress.com/news/dp-local_doctor_0328mar28,0,1578564.story

ALBANY, N.Y. (AP) - A former upstate New York cancer specialist who failed to keep accurate case histories on patients in drug studies has been sentenced to pay more than $500,000 in fines and restitution and serve five years probation.

Dr. James Holland was fired from the Stratton VA Medical Center in 2003 along with researcher Paul Kornak. He pleaded guilty in 2007 to federal charges he failed to establish and maintain adequate records and allowed patients to be improperly enrolled in the drug experiments.

http://www.wten.com/Global/story.asp?S=10084686

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Four Transplants provided from California Officer who was killed in the line of duty

3/27/2009 07:24:00 PM  ,  

The officer’s liver, kidneys and heart were donated, and all transplants were successfully completed Tuesday and early Wednesday.  Nice reminder for imageall of us to think about being on the donor list.  In California, we have the pink circle right on our driver’s license and it may vary in other states.  If you are not already registered on your driver’s license you can also register on the website.  Sad the officer lost his life in a gun battle doing his job, but wonderful his donations saved 4 other lives.  BD 

(CNN) -- Organs donated by a slain Oakland, California, police officer saved four lives, and his donated tissue will enhance the lives of up to 50 others, the California Transplant Donor Network said Wednesday.

Officer John Hege, 41, was pronounced brain dead on Sunday but was kept on life support pending a decision on organ donation. He was the fourth Oakland officer to die after a gunman fired on police in two weekend incidents.

"Officer Hege was registered on the Donate Life California Organ and Tissue Registry, which his family also supports," the donor network said in a news release. "He chose in death as he did in life to help those in need. His organ donations saved the lives of four adult males from California."

Four receive organs from slain California officer - CNN.com

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Wal-Mart Unveils New Prescription Drug Pilot Program – No Co-Pay for Tier 1

3/27/2009 10:54:00 AM  , ,  

The company is dealing direct and by-passing the 3rd party provider and gets the medications direct from Wal-Mart, so the outside pharmacy benefits manager if left out of the picture, and it appears so is the reporting information, so this may through a bit of a monkey wrench into the reporting process when tracking to see if patients are filling their prescriptions when tracking physician statistics, something that goes on today with using a $4.00 plan.image

When Pay for Performance and $4.00 Generic Prescriptions Hit the Wall

Tier one drug listings are pretty much all generic drugs.  BD

Wal Mart, which has changed the pharmacy industry by introducing their $4 generic drug program in 2006, announced another program that could revolutionize the prescription drug industry in the US. The company along with Caterpillar, a leading construction company, has embarked on this pilot drug program that could offer no co-pays for employees taking Tier-1 generics. 

As a part of this program, some of the select salaried and management employees of Caterpillar as well as its retirees and surviving spouses are allowed to get Tier-1 generic drugs with out filling any co-payment at all Wal-Mart, Sam's Clubs and Neighborhood Market stores from December 31, 2009. Generally, the co-payment for the generic drugs is $5 at other pharmacies.

Wal-Mart Unveils New Prescription Drug Program, Prevents Co-Pay System In US Drug Market

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Genomics Center Opens at El Camino Hospital - California

3/27/2009 10:31:00 AM  ,  

The center will offer 9 tests initially and will grow to 50 by year end.  The article stated there are over 2000 currently available, but the hospital is selectively working to find the tests that will best benefit diagnosis and treatments for their patients.  The number of tests is continuing to grow as the field of genomics is rapidly evolving and new breakthroughs in research are almost in the news every week.  The counseling service will be provided free of charge, after all you want to know what the findings mean and how they end up with a better personalized treatment plan.

The counseling center will be open for both physicians and patients.  The hospital is using the Microsoft Amalga and as discussed with Steve Shihadeh, vice president, Microsoft Health Solutions Group during an interview a while back, the software is geared to incorporate information as such and create the reporting system that will allow this information along with the normal clinical data to work together. 

Cancer treatment is also a focus as OncotypeDx is used to treat women with breast cancer and genomic testing will help determine whether chemotherapy will or will not help and can serve to avoid the process if tests determine it is not a treatment plan that is going to be effective.  BD 

Dr. Caroline Little Cribari of Mountain View's El Camino Hospital says it can take weeks, if not months, of trial and error to find the right medication for a patient with depression.

But with the opening of the Genomic Medicine Institute at El Camino Hospital on Thursday, Cribari and her colleagues will be able to take advantage of cutting-edge technologies that use a person's genetics to develop more effective, personalized treatments. The center will offer genetic testing, counseling and therapy.

Hospital officials say El Camino is the first community hospital in the nation to integrate genomics with standard health care. Specifically, the institute will offer nine different genetic tests through San Francisco-based DNA Direct, which maintains a Web site with information about genetic testing and therapy as well as a counseling call center where experts can advise both physicians and patients.

El Camino's new institute puts all the information in one place, Friedenberg said, and tests are contracted out to a third party so patients receive unbiased advice. Donations have also allowed the center to offer genetic counseling for free, he said.  Many tests are already helpful. For Cribari's patients, a genetic test might tell her that a person has a metabolism that processes a certain type of drug very quickly, she said. A standard dosage might not help the patient, but the test will tell her they might simply need more of the drug because they're processing it too fast.

El Camino Hospital in Mountain View opens genomics center - San Jose Mercury News

Related Reading:

Steve Shihadeh, VP Microsoft Health Solutions Group – The Amalga Software Solution for Aggregating Hospital Information (Interview)

Two More Hospitals Sign for Amalga from Microsoft

Misys Gets Funds for Allscripts Deal

Mixed results when a hospital goes public - California

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HIV risk at Miami VA hospital – Colonoscopy equipment sterilization questioned

3/27/2009 09:34:00 AM  ,  

Back in January, the VA had another issue with sending instruments and other items via delivery service to another facility to sterilize, which to me doesn’t make sense.

Sterilization at a VA Hospital – Should this be outsourced for another VA facility to sterilize tools and equipment used?

I guess it’s a good thing all of these items are coming to light though so they can be corrected.  This situation here in Florida I hope will have not exposed or been a vehicle for anyone becoming infected.  BD 

WASHINGTON -- The Miami Veterans Affairs hospital, which may have exposed thousands of veterans to HIV and hepatitis by using improperly sterilized colonoscopy equipment, gave itself a clean bill of health in January, only to discover problems two months later after a more intensive review, VA officials told U.S. House members in a closed-door briefing Thursday.

The green light came weeks after the Department of Veterans Affairs, in a Dec. 22 alert, warned veterans hospitals nationwide to check for problems associated with colonoscopy equipment. The alert followed similar reported problems at a Tennessee VA clinic that also could have exposed thousands of veterans to hepatitis and HIV.

The Miami problem arose when the tubing, pump and reservoir used in the colonoscopy procedure were rinsed after use but not disinfected as required by the manufacturer. It created a slight chance that back-flow from the pump could carry tiny amounts of virus into the patient.

HIV risk at Miami VA hospital not found until 2nd review - 5-Minute Herald - MiamiHerald.com

Related Reading:

Sterilization at a VA Hospital – Should this be outsourced for another VA facility to sterilize tools and equipment used?

Read More

Microsoft Research Trento Centre: Biology and Computer Science Coming Together

3/27/2009 12:01:00 AM  , ,  

This is the convergence of biology and computer science coming together to with a new computer language.  Algorithmic systems biology used to benefit both worlds with a new breed of scientists.  A couple of their research partners include Salk Institute for Biological Studies and GlaxoSmithKline.  This is very interesting as some of their studies are directed towards the DNA in food and nutrition to activate genes that could possibly prevent disease, so this center is all about the prevention at the core.image

The last line of this article make an interesting point, people and groups have to “grow” into it, in other words it doesn’t work by combining existing groups, a whole new world of research and algorithmic processes.  As I always say, it’ all about software when it comes to research, development and advancing technologies.  BD

In February 2005, Bill Gates, Microsoft chairman, signed an agreement in Prague, along with two ministers of the Italian government, a councilor from the Italian province of Trento, and the rector of the University of Trento, to establish The Microsoft Research – University of Trento Centre for Computational and Systems Biology (CoSBi).image 

The centre, focused on the convergence of the life sciences and computer science, was established with a specific, far-reaching vision: to foster the development of “a new kind of scientist, empowered with novel conceptual and computational tools smoothly connecting models and experiments” to “discover and better understand fundamental biological principles at different levels, from molecular to ecological systems, and thereby construct a brighter future for the quality of our lives and our environment.”

“Our partnership with the University of Trento has been a longstanding and fruitful one, combining forces to further advance the study of computational science, in particular the intersection between life sciences and computer science, and we look forward to further success stories coming out of the lab.”

imageCoSBi Lab, based on the new programming language BlenX, is an effort to develop a complete artificial laboratory that can replicate via computer simulation all the activities usually performed in wet labs. The effort offers features to analyze the outcomes of simulations including main statistical techniques and visualizations of networks of reactions and plots of concentrations.

 

CoSBi Lab comprises five free, downloadable software prototypes:

  • Beta Workbench: a collection of tools explicitly designed to represent biological entities and their interactions.
  • Cyto-Sim: a stochastic simulator of biochemical processes in hierarchical compartments that can be isolated or allowed to communicate via peripheral and integral membrane proteins.
  • Kinfer: a tool for estimating rate constants of biochemical network models from concentration data measured at discrete time points.
  • Snazer: a modular tool designed to aid the processes of visualizing and manipulating reactive models and to share and interpret time-course data.
  • Redi: a reaction-diffusion simulator built to test new diffusion models and algorithms.

In addition to better understanding of biological systems that could enhance the use of targeted medicines to fight prominent illnesses, systems-biology research on nutrigenomics promises insights into how food can interact with DNA to activate genes that prevent the onset of diseases.

Trento Centre: Award-Winning Research - Microsoft Research

Related Reading:

Microsoft’s Growing Push into Life Sciences

Microsoft Research: Research & Programs for Healthcare

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Generic biotech drugs discussed in Congress – Bio Similars

3/26/2009 11:03:00 PM  ,  

This is really a touchy situation, we want drugs that works and for a price where we can all afford.  One way or another it appears it’s going to come about but when and what the stipulations are remain to be one big gray area.  Merck for one is getting set up with one recent purchase to enter the Bio Similar market.  Right now Merck and Teva are in legal battles over the patent on Singulair, as the validity of the patent is being questioned.  I would guess there’s probably nothing wrong with the patent, but it might be more of an issue of timing.  We are at a time when health care costs are going through the ceiling and the challenge is there because it can be and an agreement to allow a generic to be produced before the original patent time could emerge, again, as Merck may get tired of the legal battle and settle, again this is just something that could occur, due to timing and the demand for affordable drugs.  

“The terms "Biosimilar" or "Follow-on Biologic" refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.”

It’s basically coming down to what we have been fighting in healthcare, who’s going to pay the bill, except in this case, who’s going to pay for the R and D?  Biotech drugs are much more complicated and the time to develop is even more so, ask Genentech for one.  

The problem with biotech is that it is complicated and not understood and that includes Congress as well as the rest of us.  Another blog put it this way:

"The biotech industry deals with an ongoing basic education challenge: that our industry is not well-understood," says Gardner. "The science behind biotech is not well understood—the process of going through basic research to clinical trials to successfully delivering a product to patients worldwide. It's incredibly complicated, it takes a long time, and we have to show that process to elected leaders."

“In 2000, Trull's firm was engaged by a New Jersey biotech called Anthra (which has since been sold and disbanded) that had a compound designed to treat bladder cancer which had been voted against, by a count of 14-0, by an FDA advisory panel. Trull's team determined that not one member of the advisory panel had expertise in the subject matter. They took the issue to a New Jersey member of Congress, who then brought up the issue with the FDA. The federal agency agreed with the criticism, and added a knowledgeable person to the panel. The product was reconsidered and approved for market.

Often, "technology gets ahead of the regulatory pathways," says Trull. "The FDA is always confronted with these kinds of challenges, and this is where lobbying really matters," she adds.”

Here’s one example of a bio-similar that was rejected by the FDA last year:

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This blog above talks about lobbying, but much in part of what is emphasized is education, so if we could lobby without politics and just focus on educating Congress and their aides, things might go a little smoother, after all we would hate to have a huge potential heart disease biotech drug over looked for one that helps cure baldness, but it happens.  I actually used that comparison as spoken recently by Bill Gates. 

The FDA had to find members with experience for their advisory panel, so perhaps we can use some of the same in Congress, some actual scientists as aids to work with and advise them, with a non partisan approach. It appears much of the R and D is leaving our shores for cheaper ground right now and we either have to compensate less here to bring cost down a bit,  or accept what is delivered in technology from outside our borders, and there’s not much in between.  We are not the only country in this scenario, but probably the largest with the most at stake. 

I read an article this week that was titled “China is the next Israel, so where does that leave Israel?”, maybe something we might ponder here as well.  BD

WASHINGTON (AP) — Biotech drugs that now cost thousands of dollars per month would have to compete with lower-cost generic versions after just five years on the market, under a new congressional proposal.

The bipartisan bill introduced Thursday is the latest salvo in a years-long effort to lower the price of biotech drugs, high-tech injectable medications that cost the nation more than $40 billion per year.

The proposal from Sen. Charles Schumer, D-N.Y., and Susan Collins, R-Maine, suggests generic drugmakers are gaining traction for their long-sought goal: a speedy, low-cost pathway to market for generic biotech.

Biotech drugs, such as the blockbuster cancer drug Avastin, currently don't face generic competition because the Food and Drug Administration doesn't have power to approve copies of such medications. Efforts to change that have been held up for nearly a decade by squabbling between the biotech and generic drug industries and their allies on Capitol Hill.

The Pharmaceutical Research and Manufacturers of America warned Thursday that a shortened exclusivity period could discourage companies from investing in drug development, jeopardizing new medicines and "high-quality, science based jobs."

"Developing biologic cures is a complex and difficult undertaking," said a statement from the group. "Congress needs to approach any changes in this arena carefully."

The European Union has been approving generic biotech drugs since 2006, with 11 years of exclusivity for original products.

The Associated Press: Generic biotech effort picks up steam in Congress

Related Reading:

Here Come the Bio Similar Drugs – Bill in Congress to allow Follow Me Provisions for the FDA

Merck Purchases Insmed – Biosimilar Biotech Drug Company
Pfizer Joins the Generic Club
Genzyme gets biosimilar rejection

Biotech Campaigns for Easier Access to Generic Drug Market - Can we put the decision making process back in the hands of the clinicians..and what about biosimilars...

Genzyme gets biosimilar rejection

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Atrial Fibrillation – What will be the future standard of care, Warfarin or the Watchman Device?

3/26/2009 09:40:00 PM  ,  

Just as we are trying to get the genomic test in place for Warfarin, there’s a new device on the horizon. The device, called the Watchman is in clinical trials and the purposes of the device is to have an alternative option to having to take blood thinning medication, and this would be a person who is taking it on a life time treatment program, so not short term here.

Additional information can be found here from the website as relates to the study and it is under review at the FDA. Medical devices that we once thought were Sci-Fi are appearing on the horizon and in use today. The device is inserted via a catheter, like many of the endovascular procedures today, so the procedure is also minimally invasive. So far 110 individuals have the device in place in current studies. BD

How is the WATCHMAN implanted? (from the website)

Using standard techniques, similar to the ones used in commonly performed angioplasty procedures, your doctor will guide the WATCHMAN device into your heart through a flexible tube (catheter) inserted through a vein in your upper leg. Once the catheter is in the correct position, your doctor will take pictures of your heart in order to take appropriate measurements of your left atrial appendage. These measurements will determine which size WATCHMAN device to use. After the device is put into place, additional measurements and pictures will be taken to make sure the device is in the correct position. Once your doctor has confirmed the position, s/he will release the device to leave it permanently implanted in your heart.

With this procedure, you would need to stay in the hospital overnight and recovery will take about 24 hours.

MINNEAPOLIS, March 26 /PRNewswire/ -- Atritech, Inc. a clinical stage medical device company, announced today that it has completed a image$30 million round of financing. Thomas, McNerney & Partners led the round along with a substantial investment from Split Rock Partners and insider investments from Prism Ventures, Tullis-Dickerson and Vector Group. Over the past 3 years, the Company has raised approximately $75 million in capital.

imageimage

With this new funding, the Company will complete the Food and Drug Administration (FDA) review of the PROTECT AF clinical trial results along with the commercial launch of the WATCHMAN(R) LAA Closure Technology in Europe. The PROTECT AF clinical trial evaluates the WATCHMAN device versus the current standard of care, warfarin, in patients with atrial fibrillation.

In August of 2008, Atritech announced the filing of its Pre-Market Approval Application (PMA) to the FDA. The Company will present the PROTECT AF results to the FDA's Circulatory System Devices Panel on April 23, 2009. The WATCHMAN device continues to be implanted in a Continued Access Registry (CAP) while the product is under review at the FDA. To date over 110 devices have been implanted in CAP at approximately 20 sites in the U.S. and Europe.

Atritech's WATCHMAN device is designed to keep harmful sized blood clots from entering a patient's blood stream, potentially causing a stroke. Patients with AF (a heart condition which causes the upper chambers of the heart to beat too rapidly) are at a greater risk of having a stroke. Typically these patients require blood thinning medications to prevent these clots from forming in the heart. Current medical therapy requires frequent monitoring and has diet and other drug interactions causing many patients to stop taking them. The WATCHMAN device may be an effective alternative for patients with AF who may not want to take blood thinning medications for life.

Atritech, Inc. :: Atritech Completes $30 Million Financing

Related Reading:

Plavix – What’s the next step for doctors and patients – possible genetic testing in the near future?
Genetic warfarin test not cost-effective in guiding initial dosing of common blood thinner
Who's going to pay for the Warfarin Test - Personalized Medicine
Genetic Testing Improves Some Warfarin Dosing

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Lance Armstrong’s Surgery comes with a good prognosis

3/26/2009 07:50:00 PM  ,  

I also read he couldn’t resist using Twitter from the hospital to let everyone know he was alive and well.  His website where you can follow his events and learn about healthy living is called LiveStrong and he can also be found on Facebook.  I have been fortunate enough to have a couple of my web quacks posted at the site in the recent past.  The Medical Quack is a fan and we hope to see him back in action soon.  He has literally had internal hardware now.  BD 

"Surgery was tough, but went well," said Dr. Douglas Elenz, an orthopedic surgeon in Austin, Texas, who performed the three-hour procedure two days after Armstrong fractured his collarbone into four pieces during a race in Spain.image

imageThe multiple breaks "made treatment more challenging, but we're confident that the treatment performed today is going to be successful," he said.

Elenz said he used a 4- to 5-inch plate that he attached with 12 inch-long screws to stabilize the fractured bone.

Armstrong, 37, was to be released later in the day.

On a scale of one to 10 rating the difficulty of the operation, Elenz said he would pin it down at eight.

After his wound has healed, Armstrong will begin using an exercise bike to train his lower body, "but we won't let him do a whole lot with his upper extremities," Elenz said.

"After several weeks, we can take his training to the street, but we will need to take that day by day and week by week."

Surgeon declares operation on Lance Armstrong a success - CNN.com

Related Reading:

The Medical Quack is now a Fan of Lance Armstrong and LiveStrong

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New Technology Assesses Breast Cancer Risk – The Breast Pap

3/26/2009 07:32:00 PM  ,  

This is a new FDA approved procedure and device that can help in the early detection of breast cancer.  The two clinics mentioned here have made the test a part of their normal well woman exam.  What’s nice is that there is no special training required for the testing or certification as it appears to be pretty well automated.image

Women as young as 25 can have the test.  The testing is screening and not a diagnostic test, just like you get screened  for high cholesterol screen for potential cardiovascular issues.  It does not replace a mammogram.  The fluid sample is sent to the lab and analyzed for cellular changes.  Not producing fluid with the HALO test is considered a normal result, meaning you are at normal risk, not elevated risk for developing breast cancer.  If an abnormal result is returned, the patient is usually referred to a breast center for further evaluation, again this is screening with the procedure to determine if one is a high risk patient early.  It is a pap tests for the breast.  BD

From the Website:

The HALO Breast Pap Test is the only fully automated, noninvasive NAF collection system specifically designed for use in a busy primary care setting.

The HALO System provides important benefits to clinicians and patients:
For clinicians:

  • Routine NAF screening
  • Objective assessment for documentation
  • Consistent and reproducible image
  • Fully automated
  • User friendly - requires no specialized training or certification
  • Performed by office staff
  • Easily transported from room to room
For patients: image
  • Noninvasive 
  • Simple, 5-minute procedure
  • Can be performed during annual check up
  • Well tolerated by most patients
  • Safe, with no side effects
HALO is not a diagnostic test and it cannot be used to exclude breast cancer. Patients should continue to undergo other clinical breast screening procedures (mammography, clinical breast examination, self breast examination) as determined by and with their physicians.image

Press Release:

Pacific Breast Care, Newport Beach OB/GYN Featured in Presentations at Breast Health Meeting

LAS VEGAS – Two scientific poster presentations by physicians from Pacific Breast Care (Costa Mesa, Calif.) and Newport Beach OB/GYN Medical Group, Inc. (Newport Beach, Calif.) were featured at the recent 19th Annual National Interdisciplinary Breast Center Conference. The conference was the annual meeting of the National Consortium of Breast Centers (NCBC).

One poster described a collaborative relationship between the two medical practices in which women identified with elevated breast cancer risk at Newport Beach OB/GYN are presented with risk-reduction options at Pacific Breast Care.

The relationship was made possible by relatively new technology, an automated device for collecting nipple aspirate fluid (NAF). The device is called the HALO® Breast Pap Test (NeoMatrix, Irvine, Calif.). NAF is a valued biomarker for breast cancer risk in asymptomatic women.

Pacific Breast Care breast surgeon Alice Police, M.D. and Newport Beach OB/GYN’s Patricia Korber, M.D. were co-authors of the poster.

“The NAF device has transformed the way we assess breast cancer risk in women,” said Dr. Korber. “Atypia – that is, abnormal cells – in NAF has long been known to be a reliable marker for risk. But until this technology was available, there was no practical way to collect NAF in a community medical practice. Now, we can collect the fluid easily and non-invasively, in a manner that’s easy for patients. That has enabled us to make this risk screen a part of our regular well-woman exam.”

NAF testing is a useful adjunct to regular breast cancer screening because it can be used in women 25 and older, identifying precancerous changes years before a palpable or imageable lesion might be found. A cancer has been growing for 8 years on average before it can be detected by a mammogram, and 10 years before it can be palpated. The scientific literature shows that women with atypia in their NAF have a 4-5 times greater risk of developing breast cancer than women who do not produce NAF.

The device used at Newport Beach OB/GYN employs warmth, massage and suction, much like a breast pump, to collect NAF. Patients who have atypia in their NAF are then referred to Pacific Breast Care for risk-reduction counseling and follow-up.

“Risk prevention strategies can reduce risk by as much as 86 percent for women who chose chemoprevention medications,” said Dr. Police. “Other strategies that we offer at Pacific Breast Care are also proven to reduce risk significantly. The NAF device has helped identify more women who can benefit from these approaches.”

Besides chemopreventive medications, other risk reduction strategies counseled by Pacific Breast Care include increased surveillance, lifestyle changes, and genetic counseling/testing.

Dr. Korber noted that the approach developed by the two practices is particularly beneficial for women between the ages of 25 and 50. Women in this group tend to have breasts that are too dense for mammograms to be effective. In addition, breast cancer at younger ages is more likely to be fatal, increasing the importance of cancer risk assessment for these women.

In addition to the medical benefits for patients, both practices have used the HALO test to expand their practices.

The second poster featured at NCBC explored the way that atypia findings with the NAF device have changed the “care path,” or treatment protocol, for high-risk patients at Pacific Breast Care.

The poster was by Dr. Police and Linda Frye, M.D., a radiologist at Pacific Breast Care.

Drs. Police and Frye reviewed the cases of 17 patients referred to their practice because of findings of NAF atypia. All 17 were put under increased surveillance with mammography, ultrasound or MRI. Five of the patients had positive imaging studies soon after the atypia findings. The other twelve will continue to be monitored closely by Pacific Breast Care.

“Our review of patients with atypia underlined the importance of testing NAF,” said Dr. Frye. “Some of these patients had put off mammography. Atypia findings motivated them to get mammograms or other imaging studies. These patients will be followed more closely by our practice. If any cancers develop, they can be detected early, when they are more successfully treated. The strategies we suggest may be able to prevent cancer altogether.”

The NCBC meeting was held March 15-18 in Las Vegas.

About Newport Beach OB/GYN Medical Group, Inc.

The clinical staff of Newport Beach OB/GYN Medical Group serve as primary care providers for annual "well-woman" exams, obstetrical care and delivery, and other female-related conditions. The practice also offers a range of aesthetic services. For more information, call the Newport Beach office at 949-642-5775, the Huntington Beach office at 714-274-0414, or visit www.nb-obgyn.com.

About Pacific Breast Care

Pacific Breast Care provides the only comprehensive breast health services available in Orange County, Calif. The practice is focused equally on prevention, detection, and treatment. In addition to offering diagnostic and surgical procedures, the facility operates a high-risk clinic that offers genetic testing and counseling and prevention strategies based on family history, clinical background, and lifestyle. For more information, call 877-277-8271 or visit http://pacificbreastcare.com.

Pacific Breast Care, Newport Beach OB/GYN Featured in Presentations at Breast Health Meeting

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Cerebral Aneurism surgery Can be performed with Catheters

3/26/2009 06:51:00 PM  , ,  

We have all read about catheter surgery for the heart and now it is moving up to neurosurgery as well.  This is amazing how technology with surgical methodologies is going.  This surgery more than likely saved the patient from a fatal stroke.  Most of the time, aneurisms have no symptoms and are found usually when a patient is consulting for other health problems. 

A few months ago I had the opportunity to talk about this minimally invasive type of surgery with endovascular surgeon from Yale University, again this was related to the heart, but the basic procedures of not cutting open an incision and using a catheter is somewhat the same in principle. 

Interview with Bart E. Muhs, M.D., Yale School of Medicine – Aneurysm Repair Surgery

She was actually lucky as she had symptoms.  The patient spent one night in hospital and went home the next day with a band aid on her leg and returned to work in a day.  BD 

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Norma Wooley checked into Loyola University Hospital on a recent Monday morning for brain surgery to repair a life-threatening aneurism (also: aneurysm).  She went home on Tuesday, cured of the slurred speech, drooping face and worst headache of her life.

Wooley had a cerebral aneurism, a weak spot in a blood vessel that balloons out and fills with blood. About six million Americans -- 1 in 50 people -- have brain aneurisms that could rupture. Each year, aneurisms burst in about 25,000 people, and most die or suffer permanent disabilities, according to the Brain Aneurysm Foundation.
Dr. John Whapham, assistant professor in the Departments of Neurology and Neurological Surgery, Loyola University Chicago Stritch School of Medicine, used a less-invasive technique that's becoming increasingly common in brain surgery; he inserted a catheter (thin tube) in an artery in Wooley's leg and guided it up to her brain. The catheter released tiny platinum coils into the bulging aneurism, effectively sealing it off.

Life Threatening Aneurism - Surgery Monday, Home Tuesday With A Band Aid

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Dr. Howard Koh nominated for Assistant Secretary of Health

3/26/2009 01:08:00 PM  ,  

One more from the “smart store”, and it is good to see doctors finally being involved to a degree where they can be heard and make a difference. Hopefully both he and his brother, will be approved by the Senate and taxes are paid.  BD  

President Obama this evening nominated Dr. Howard Koh, an associate dean at the Harvard School of Public Health and former Massachusetts public health commissioner, to a top health position in his administration.

As an assistant secretary for health, Koh would be responsible for establishing the nation's public health agenda if confirmed by the Senate.  He is one of the few doctors with certifications from four specialty boards of medicine: internal medicine, hematology, medical oncology, and dermatology

He is the second member of his family to be nominated to a top Obama administration post this week: On Monday, his brother, Yale Law School Dean Harold Koh, was picked to be the State Department's legal adviser, a post that also requires Senate approval.

Howard Koh served as the public health commissioner in Massachusetts from 1997 to 2003, first being appointed by Governor William Weld and continuing in the office through the Paul Cellucci and Jane Swift administrations before resigning in the early days of the Mitt Romney administration.

Former Mass. health commissioner nominated to federal post - White Coat Notes - Boston.com

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US Drug Sales are Flat – India Experiencing a 13.3% growth

3/26/2009 12:53:00 PM  ,  

A comparison to the growth in the pharmaceutical business, we are basically flat here, while overseas in India the market continues on a steady growth pattern.  Also, in the US it is becoming much more difficult for sales and marketing representatives to get appointments to see physicians, they are busy like everyone else and have more information and constraints piling up every day, so the time they have to share is limited.  Only 16% of their time is spent directed to medical care today according to recent reports, and the rest is spent on administrative tasks and waiting for imageinformation, labs, etc.  BD

* 2008 U.S. drug sales up 1.3 pct

* Sales growth reflects continuing slowdown

* Cheaper generics, weak economy, hurt branded drugs (Adds quotes from IMS Health analyst, updates shares)

NEW YORK, March 19 (Reuters) - Sales of prescription drugs in the United States rose an anemic 1.3 percent in 2008 to $291 billion in a continuing slowdown, as patients opted for cheaper generic versions or chose to go without treatment due to the economic downturn.

UPDATE 2-U.S. drug sales show anemic growth in '08 | Markets | Markets News | Reuters

NEW DELHI: India’s drug retail industry continued its healthy growth recording 13.3% higher sales in February over the same month last year. Domestic pharma firm Cipla continues to hold the top position in sales, as per data compiled by research firm ORG IMS.
Growth in February marks the fourth straight month of higher drug sales in the country after the drug retail market contracted for the first time in many years by 1.2% in October 2008. This had surprised industry analysts as demand for medicines is need-based and considered immune to economic slowdown which has hit most sectors.

http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare--Biotech/Pharmaceuticals/Pharma-industry-posts-133-growth-sales/articleshow/4310689.cms

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This is a Cloud? What a Portable Data Center Looks like…

3/26/2009 12:41:00 PM  , ,  

I hope I have not spoiled anyone’s vision on what “cloud computing” may look like, but this is what the portable data centers look like, not really a cloud at all, but some pretty interesting pictures, thanks to ZDNet.  It is amazing how all this data is crammed into such a small area.  Not all cloud data is destined for portable centers I might guess, but here’s the future on portable data centers.  BD 

It takes mucho computes and terabytes to create the 3D models used in Microsoft’s Virtual Earth online mapping service. So how do they cram 5,000 cores and 10,000 terabytes - 10 petabytes - of storage into 3 40 ft. shipping containers?

Containerized data centers
Sun pioneered containerized data centers with their 2006 water-cooled Project Blackbox. But the Microsoft model is air-cooled and in production today in Boulder, CO.

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Inside a Microsoft data center | Storage Bits | ZDNet.com

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While You are investigating us, we don’t want to violate ethics and will find another keynote speaker

3/26/2009 12:20:00 PM  ,  

This is worth reading, and probably a good decision for whatever the reason might be for both sides due to the ongoing investigation.  BD 

Tufts University has withdrawn an invitation for a top aide to US Senator Charles E. Grassley to give the keynote speech at a conference on conflicts of interest in medicine and research, leading one conference organizer to pull out and question the university's commitment to academic freedom.

The medical school provided two different answers as to why Thacker was disinvited.

Spokeswoman Christine Fennelly first said in an e-mail that when Grassley declined the invitation, "it was decided to refocus the symposium on a smaller scale, where the panelists would be faculty from Tufts University and affiliated faculty from Tufts Medical Center."

Later, when told that Krimsky's e-mails explicitly said the speaking offer was rescinded, she said the invitation to Grassley's aide had been withdrawn. "Indeed . . . the administration felt it prudent to not engage someone from the Senator's office while we respond to the Senator's inquiry," she wrote.

Kozeny, Grassley's press secretary, said, "These issues merit more discussion and less circling the wagons. It's too bad a reform perspective has been removed from the program."

Ethics event spawns a tussle at Tufts - The Boston Globe

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Twitter Stream on the Medical Quack Blog – Latest Tweets or “Quacks” in my Case on Twitter

3/26/2009 12:05:00 PM  ,  

I have added one more added resource, the Twitter Stream to the site.  It is located on the far right hand side, scroll down to view.  While on the Medical Quack blog site, you can also see what’s going on with my Tweets.  As you have probably figured out I send all my posts on the blog to Twitter; however when I have some time I do engage in some Tweet conversations and the latest will be shown.  I like the Stream as I was able to customize it to the colors and theme of the blog as well.

Thanks again too all the readers here and tell a friend, it’s appreciated!

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If you want to check in and see who’s reading what here, you can also use the Live Feed link, also from FeedJit, as older posts again become visible and it could be a topic you might be interested in, link a the bottom of the site as well as at the the bottom of the Live Feed.  It gets addictive though, or at least is does for me.  BD 

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3M Selected In Louisville enters the PHR Health Records business with the “bank” for Consumers

3/26/2009 11:45:00 AM  ,  

One more entry into the field of personal health records through the Louisville Health Information Exchange.  In essence from it appears this will offer consumers in the Louisville area another choice on what they can do and how they can access their health records, share, etc.  The article doesn’t mention medications from drug stores as some of the other PHRs offer.  I do like the website though at 3M, very good work with flash, like a keyboard to look up the services and products they offer.    BD 

SALT LAKE CITY--(BUSINESS WIRE)--The Louisville Health Information Exchange (LouHIE) has selected 3M Health Information Systems to provide the electronic health record banking system and interoperability solution to enable health information exchange across the greater Louisville area. 3M and its partner, InterComponentWare, Inc. (ICW), will design, build, and pilot an integrated health information network that will offer free health record banking services to all 1.2 million citizens in the greater Louisville community. The parties will be negotiating a definitive agreement.

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“LouHIE will work closely with Kentucky state officials working on statewide health information exchange,” said Steve Beshear, Governor of the Commonwealth of Kentucky. “The state is excited about the opportunity to collaborate with LouHIE, 3M, ICW, and the Louisville area leaders in creating Kentucky’s e-health research laboratory for the nation.” Louisville Mayor Jerry Abramson added, “Louisville has been working on an electronic health data network for three years now—and we can be a national model for how to implement the system.”

When implemented, the LouHIE initiative will enable consumers to store and manage their patient data in a private and secure personal health record bank. Each bank account will contain an electronic copy of an individual’s health records, consolidated from the various clinics, hospitals, and physician practices where the individual received care. Each individual will control his/her health record bank information and will be able to choose to make the complete record available to providers at healthcare facilities in the greater Louisville area or access their own record via the internet. The LouHIE project is expected to be a model for other cities, regions, and states that want to create health information exchanges (HIEs) based on a centralized health record bank.

3M Selected to Build Louisville Health Information Exchange

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Germ-Zapping Keyboard – for use in Hospitals to help prevent the spread of MRSA, C Diff, and other bacterial infections

3/26/2009 10:33:00 AM  ,  

This is a start up company that hopes to bring this product to market this year.  The report stated this was the easiest fund raiser he has ever experienced and when you see the product, it’s a no brainer.

The user can push a button to have the keyboard retract, and that motion exposes the keyboard to the lamp that will disinfect the keyboard for the next user.  Also, after a period of no activity, the device will auto clean as well and the cleaning cycle can be interrupted at any time if access is needed immediately.   Hopefully the item will be in the affordable price range as this looks to have huge potential in preventing infection spread throughout the hospital, and for that matter in a larger medical practice where many are sharing computers and keyboard.  Recently I posted about a vacuum cleaner from Oreck that was using a similar technology to disinfect with lamp technologies.  Recently there was the doctor who also discovered that taking the paper gown and stuffing it into his glove was also contributing toward the spread of MRSA, and then of course there’s the most important item of just washing our hands. 

There’s nose spray too that can kill MRSA as one in every 20 individuals in a hospital according to a recent study carries MRSA.  Johnson and Johnson is also waiting for their new drug that can fight MRSA to be approved by the FDA.  With MRSA and C Diff there’s a lot of research and new technology in the works and some of it available today to help eliminate the further spread of hospital acquired infections.  The related reading below has several links on prior posts relative to both MRSA and C Diff.  In  my opinion, the keyboard appears to be a real winner in the fight against infections at the hospitals.  BD 

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How the Vioguard keyboard works: (from the website)

Vioguard's system safely floods the keyboard and pointing device with a powerful germicidal UV lamp, eliminating the need for manual disinfection. An infrared proximity sensor activates a motorized drawer, which presents a disinfected keyboard to the user.

Once the user is finished, they can activate the disinfection cycle by pressing a button on the keyboard drawer - or, after a predetermined period of inactivity, the system will automatically initiate a disinfection cycle. LED indicators are used to let the user know when the keyboard is ready for use. The disinfection cycle can be interrupted anytime to ensure the device is available as needed.

 

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The concept is simple: a computer keyboard that self-sanitizes by zapping potentially deadly germs with ultraviolet light. The technology could help prevent the spread of nasty bacterial invaders like MRSA in hospitals and other institutions with shared computer facilities. That’s the idea behind Vioguard, a Bothell, WA, company co-founded by startup specialist Larry Ranta and his nephew, Craig Ranta, a former hardware engineering director at Microsoft. Larry is Vioguard’s president and CEO, while Craig is the chief technology officer.

He seems to have hit on something big with Vioguard. Hospitals are especially motivated to rid their environments of deadly bacteria like MRSA and “C. Diff,” which are seeing fast-growing incidence. About 30 to 40 cases of C. Diff bacteria—which causes horrible and sometimes fatal cases of diarrhea—were reported per 100,000 people discharged from hospitals in 2001, and that figure tripled to about 100 cases per 100,000 discharges in 2005, according to data from the Centers for Disease Control and Prevention.

Data is elusive on these kinds of bugs, because hospitals hate to admit any guilt and invite legal liability, but this is undoubtedly a growth market. (Pfizer’s anti-MRSA antibiotic, linezolid (Zyvox), topped $1 billion in worldwide sales last year.)

Vioguard CEO Larry Ranta Takes Germ-Zapping Keyboard Into Growing Hospital Market | Xconomy

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