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Medical Quackadryl - talk to your blogger to see if this right for you...

image This is fun and just down right silly. Cedra is a clinical research organization created something for fun, so why not, now I have my own drug.  If you have nothing better to do for a few moments, have a little fun.  Thanks to the folks at Pharmagossip for submerging my brain and time here:)

And here's my drug....you can go here to create your own.

 

"If you think Medical Quackadryl is right for you, talk to your blogger"....BD 

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CEDRA Clinical Research | Main

A Social Network for Your Doctor, Pharmacist and Insurer

"WellNet will give companies the program for free if they transfer their pharmacy benefits to WellNet" so it can be tracked better, as now if you go and pay cash for a generic $4.00 drug, it's out of the insurance system as far as I know.  I hear this from doctors who get dinged for not prescribing enough generic drugs on their pay for performance incentive pay, as if enough patients use the $4.00 generic cash programs, it stilts the numbers for the over all practice.  The one comment below is also a very good point about employers having information relative to the medications an employee is taking. 

I have already seen something similar to this in places of employment where the employee is liked until they end up sick and contribute to the employer having to deal with higher rates, and then they are not so popular anymore when it comes to counting the beans and dollars and granted the interest is in the information flow, but once more what do we give up for this?  How far in health care do we refine the dollar, to the point where it's almost gone where nobody is paying the bills and to where employees just simply opt out of participating?  I have been doing my own survey of asking people how satisfied they are with our current health system and I have yet to find one positive out of asking around 100 or so people.  BD

WellNet Healthcare, a Bethesda health management company, is launching the beta version of this social network, Point to Point Healthcare, this month. Since 1994, WellNet has built its business collecting detailed data on employees' medical and pharmacy activity so that companies can better evaluate their corporate health plans.

And others have reservations about what information employers will have access to. WellNet said it plans to collect anonymous data allowing employers to see, for instance, how many people are using certain drugs and specialists -- something it already does under its existing systems.  "What if you have a very expensive employee who takes tons of medicine? What does this mean?" Pam Dixon, executive director of the World Privacy Forum, said about efforts similar to WellNet's. "These are very sensitive areas."

A Social Network for Your Doctor, Pharmacist and Insurer - washingtonpost.com

Helicos BioSciences and Personalized Medicine - Featured Interview with Dr. Patrice Milos

Patrice Milos, Vice President and Chief Scientific Officer, Helicos BioSciences image

imageThis week I had the opportunity to talk with Patrice Milos from Helicos BioSciences who has a long background in global research and spent a number of years at Pfizer as Executive Director at Pfizer Global Research and Development prior to working at Helicos. Her focus has been Cardiovascular and Metabolic Disease, Pharmacogenomics, DNA Sequencing, Biomarkers and Molecular Sciences. The interview and conversation offered some very unique views of how genetics and the drug industry are collaborating to make personalized medicine a more prevalent option in the healthcare industry. Before getting started I also wanted to make note of Helicos being in the news this week with their new collaboration efforts with a University in Sweden and more can be read here.

One area we both strongly agreed upon is the use of software, from a data person like myself and with Dr. Milos with her area of research, we both absolutely concur that software is what makes all of this possible. Being that I have readers from all areas of the Internet, this interview is done in the interest of trying to keep things as simple as possible to be able to give all readers some valuable information and insight into what is happening in the world of genomics and personalized medicine.

Helicos BioSciences, a life science company focused on genetic analysis technologies for the research, drug discovery, and diagnostic markets, has announced a scientific collaboration with a genomics research group at Sweden's Uppsala University aimed at gaining new insights into how genome structure plays a key role in the ways genes are regulated within cells. The Uppsala team, will work with Helicos scientists on a research plan designed to utilize Helicos' proprietary True Single Molecule Sequencing (tSMS) technology to investigate changes in the cell nucleus that occur in the presence of growth factors.

Additional press releases can be read here.

And on with the interview:

First of all, How large is the facility and how many technicians and employees work for Helicos?

Helicos has 3 facilities in the Cambridge, Massachusetts area, with approximately 120 employees. One houses the administrative offices and the other two facilities are for research and product development. Helicos opened the doors for business in the year 2003.

What exactly is a gene sequence?

imageGene sequencing is a whole new vision to define enzyme actions. Much of my past work at Pfizer involved research with Lipitor. We are finding that research with RNA is much more complex than anyone imagined. RNA (ribonucleic acid) is responsible for translating the genetic code of DNA into proteins. There really is no simple way to explain the process, but it enables the transcription of genetic information and the production of new proteins to give an interpretation of protein synthesis within a cell. Helicos is the first genetic analyzer to utilize single molecule sequencing. Research and development has been going on for a number of years in this area, but only recently is there more of a public awareness with the recent discoveries and breakthroughs.

Pharmacogenomics is the new term for much of the research in process, is this the same as Personalized Medicine and how does it relate?

Pharmacogenomics is the ability to understand risk. With genomic research we are able to find the right medication for patient treatment plans, and know up front what side effects may be present. Expression analysis allows this to occur, and examines the single gene interactions with drugs. Drugs as well as drug combinations are optimized for each individual's unique genetic makeup and creates a plan which is called "Personalized Medicine", in other words a plan created specially for each patient created to avoid potential dangerous side effects along with determining how effective the medications will be for the individual.

How does the technology help with drug development?

Pharmaceutical companies today must have an interest in the Biotech Industry to survive. I had a very active role at Pfizer as well over the imageyears in getting the movement started in this direction. Biotech ends up being somewhat of a "service" business for the Pharmaceutical industry. We have spoken and worked with many pharmaceutical companies and will continue this effort with research and development. The market is changing rapidly today and without Biotech and genomics, it would be difficult to survive today based on methodologies used in the past.

I spend much of my time speaking and spreading the word of genomics to many universities. Education and enlightening others is the key to the success of personalized medicine. The technology is moving faster today than we ever imagined, and thus the training and education processes need to be in high gear.

What are the focus areas of research for Helicos? Cancer? Others?

Yes, cancer is a big area of focus for Helicos, cancerous tumors in particular of interest. There are many samples, etc. that can be researched and studied. Labs, etc. have tumors that have been removed from individuals that can offer much in the area of research. Any samples we can secure and study are obviously a real plus to unlocking additional information that can be utilized to help in the research of genomic studies, as the more information that can be gained up front, it makes for a better patient treatment plan, or in the pharmaceutical area, it helps in the complicated process of creating a drug that will create a high level of success in combating cancer.

When studies are conducted, are all interpretations going to be equal, in other words the same samples with the same expressions reviewed from different sources, will the conclusions be the same?

That is a very good question and something I speak about often. The field is still very young and new information is gathered daily. As the field of genomics and personalized medicine grows there may be more of this type of activity with several interpretations taking place. It's hard to give a solid answer as to how this will unveil in time, but it is an awareness that is discussed quite frequently. I currently serve on the National Advisory Council for Human Genome Research as well as contributing to editorial boards for journals and have published and presented extensively in the genomics area.

What is the HeliScopeTM Single Molecule Sequencer?image

The best way to describe the HeliScopeTM Single Molecule Sequencer that is it is about the size of a big "freezer". This is the machine that sequences and runs the genomic expressions to deliver the results. It functions by capturing images to observe sequencing-by-synthesis reactions for billions of individual DNA molecules. It produces digital data and produces over 2 Gigabases of sequence data per day. It is a DNA microscope and has a touch screen interface for the end users.

imageTell me a little about the software, how does it work? I hear some of the same familiar words that I am familiar with from the computer code side of things, like expressions, arrays, items that I am familiar with.

It is a web based application that also can be accessed remotely. In other words there's no need to be present at the facility to view results and run reports.

In essence, the software application is the brain and functions much like any other software application in the fact that it has an administrator to design and set parameters to derive and generate the desired data. The control center can also be used to monitor more than one machine.

What is a flow cell?

The flow cells are a part of the process used to grow the DNA, it contains images of the end strands of and later it can be downloaded into a imageflat file. To run a full sequence at present it takes approximately 6 weeks to gain the full study with 5 to 10 runs. This is an area of focus to where we are working to bring this time element down to a shorter duration, in other words, with shortening the processing time, results and data can be evaluated at a faster pace and made available, valuable as an example for clinical trials. Shortening the process time is a primary focus and the demand for this is high. The ongoing development of the software is the key to making this happen.

I read where Helicos is similar to being compared to the "Intel chip", could you elaborate on this a little, what sets Helicos apart from some of the competition, is the advanced R and D research similar to processing chips with making the progression somewhat modular and using a smaller amount of space?

Certainly the process shares the same underlying theories, to be able to secure and attain more information in a smaller space. Using single cell processing is part of what is allowing this area of development to grow.

I depend on my family physician to help guide me with my healthcare, and I am curious as to what is being done to help educate the medical community on how to use and relay this information to me, as a patient, what is being done from the education side of things to help the physicians to take advantage and use this information for better healthcare? Will some of this information end up in my chart?

I spend a great deal of my time with interacting and lecturing at many universities to help bring this to the forefront. You are correct that this is an area needing to be addressed and quickly as the pace of growth continues to be accelerated compared to what we have experienced in the past. One example that has been in the news lately is the use of the drug "Warfarin" also know as by a common brand name Coumadin; about 10% of drugs approved by the FDA include pharmacogenomic information on their labels.

Responses may depend not on a single gene but, rather, on multiple genes. Genomic biomarkers help identify which patients will or will not benefit from certain drugs. Warfarin sensitivity tests have been cleared by the FDA as an aid to identify patients at risk for increased sensitivity to the widely used blood-thinning drug. This information can help avoid serious bleeding events and the event of a potential stroke.

For physicians charting this type of information, one of the first areas that could be explored would encompass drug metabolism information. This is a potential area that a software vendor could begin investigating today in reference to incorporating this information in to an electronic medical record system. All this will need to be provided in a format that will allow the physician to view and evaluate this information quickly in the fast paced world of the family practice physician in particular.

Where does the money come from for research? Is it grants, private donations?

Revenue comes from both areas. Venture capitalists play a huge role today in helping finance the research and development and much of the information we have today would not be possible if it were not for their investments. Grants of course play a very vital role as well, and sometimes it turns into quite a lengthy process, as the bar for applying and receiving grants has risen. I currently sit on a board that reviews and discusses the process, and some of the areas we look at for example deal with having made the right decisions, in plain English, are the right decisions being made to direct the grants in the appropriate direction, which can be complicated at times and requires some very detailed information to be reviewed.

What is the market for the HeliScopeTM Single Molecule Sequencer? Where does the product make it's entry in to the field of research and development?

As mentioned above, Helicos and the Uppsala University have a very important relationship and collaboration, Uppsala has not ordered a HeliScopeTM Single Molecule Sequencer; however a second order has recently been secured from a U.S. cancer center.

In March, we announced our first shipment to Expression Analysis of Durham, North Carolina. The sales was predicated on accuracy of its single molecule sequencing as discussed above. Expression Analysis is a leading provider of genomic services in clinical trials and research and the HeliScopeTM Single Molecule Sequencer fits right into the future plans in being the core element that will enable them to offer genome analysis at or below the $1,000 in the future.

Beyond the services offered by the analysis firms, universities and anyone involved in genomic research is certainly a target market for us to provide the products and software to make it all happen. It's a very fast paced world growing today that is not only impacting the way medicine is practiced, but how we live our lives.

End of interview....

I want to personally thank Dr. Milos for taking time to speak with me today. I certainly learned quite a bit today and have a much better understanding of how the world of genomics is changing and what companies such as Helicos are doing to promote and drive these processes and bring personalized medicine to the forefront. I hope my readers also find this information to be both helpful and informative. BD

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Additional reading and information can be found at the Helicos website.

States Say no to pre-emption for Drug Legal Suits

Does this say that the FDA is perhaps not as trusted as we might like the agency to be?  On the other hand is it possible to entrust any agency to this level today, and that might be more to the point.  There are so many areas that need to come to focus and with all the information we have available today, is it possible to entrust an agency 100%, I think not.  BD 

Forty-seven states are weighing in on the legal battle over pre-emption--and predictably enough, they're against it. The pre-emption doctrine would, of course, enshrine FDA approval as the be-all and end-all of drug safety. If the agency has blessed a drug for sale, then drugmakers are covered; nobody could sue drugmakers for damages in state court. Or so the reasoning goes. The states aren't convinced. They're asking the U.S. Supreme Court to uphold a Vermont ruling in Wyeth v. Levine, the case of a professional musician whose arm had to be amputated after she was injected with one of the drugmaker's products. The musician was awarded $6.8 million in damages, and Vermont's high court wasn't convinced by Wyeth's argument that FDA approval should shield it from liability.

States: Say no to pre-emption - FiercePharma

Insurance Covers Data Breach Costs

Data breaches seem to have become more common these days with more information working through the web and now there's insurance that can be purchased, which will even cover any fines according to this article.  BD

A unit of the alliance, Premier Insurance Management Services, Charlotte, N.C., is offering the data privacy and network risk liability insurance in partnership with Media/Professional Insurance, Kansas City, Mo. The insurance covers such expenses as crisis management, public relations and customer notification. It also covers expenses, fines and penalties arising from government and regulatory agency investigations into the handling of personal data.

Insurance Covers Data Breach Costs

Boston Scientific Recalls Neck Artery Stent Products and patent infringement case continues

Stents are being recalled, but not any already implanted, and in a related story the lawsuit between Boston Scientific and Medtronic's also continues with an appeal over patent infringements.  BD

BOSTON -(Dow Jones)- Boston Scientific Corp. (BSX) has recalled products used in procedures to unclog neck arteries due to issues with a stent delivery system, according to the Food and Drug Administration. The agency reported on its Web site Thursday that Boston Scientific has recalled its "NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System". The recall - which does not affects stents that have already been implanted - involves devices manufactured from June 12, 2007 to May 2 this year, the FDA said.

FDA: Boston Scientific Recalls Neck Artery Stent Products

Airborne Coughs Up Millions to Settle Suit

The case that Airborne falsely claimed its products could cure or prevent colds, was settled earlier this year for $23.5 million and now 6.5 imagemillion more dollars have been added to the settlement.  As the article states, the FDA needs to grant approval for such products, but the product has been on the market for years.  Now advertising on the packaging is changing.  If you purchased product between2001 and 2008 you have until Sept. 15 to get a refund for as many as six purchases.  Details are also posted at the website.  BD 

Over the past decade, millions of consumers, including Oprah, have come to swear by Airborne -- fizzy orange tablets containing vitamins, herbs and minerals that its makers for years said keeps cold germs at bay. Gena Crowe of Fairfax says she doesn't get on a plane without it. "If I feel like a sore throat is coming on," she said, "it seems to take it away.

She started selling in 1997, three after Congress voted to allow dietary supplement makers to claim their products have an effect on a body structure or function, such as the immune system. However, they can't claim to cure or treat illnesses without FDA approval.

Airborne Coughs Up Millions to Settle Suit - washingtonpost.com

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FiatLux Imaging - Mobile and Desktop PACS

The software will allow doctors to work with the images on standard PCs or PDAs.  No more having to depend on a web browser if you need imagelocal access.  According to the comments and reviews this one definitely worth a look if you are in radiology.  The continuity and smoothness of performance were slated as being at the top of the ladder.  Of course this will work well with a Tablet PC as well and was created by 3 Microsoft veterans.  Be sure to get a high performing Tablet PC, with 2 or 3 Gs of ram for the best performance.  BD 

 

Imaging is developing the next-generation of medical imaging software with redefined quality, speed, integration and pricing for your entire enterprise from tablets to workstations.At FiatLux Imaging we’re developing solutions that serve a broad range of medical professionals who will benefit from improved medical imaging visualization. Neurosurgeons, cardiologists, orthopedists, oncologists, radiologists, and other physicians will enjoy greater collaboration and improved patient care.

(FiatLux will charge $2,825 for a software license. By contrast, several doctors said traditional software, along with the specialized workstation necessary to run it, can cost as much as $100,000). FiatLux is the brainchild of three Microsoft Corp. veterans - Feider, Quentin Dewolf and John Pella - who started the firm in April 2007

FiatLux Imaging

Seattle Post-Intelligencer via Medgadget

Allscripts User Conference - Electronic Records Update

New rebranding information - Allscripts had renamed many of their current products, read the entire article for additional  information from the conference.  BD 

Allscripts has decided to rebrand their “solutions”!

Maybe it’s unavoidable in a time of consolidations and acquisitions that these companies will reevaluate their portfolios of applications from time to time and try to give them names that will make them easier to describe and sell. But it’s a real pain for existing customers to reprogram your users. No more Touchworks?

In a nutshell, what they’ve done is taken all the products that they’ve developed or acquired and relabeled them with some variety of “Allscripts” moniker.

Canopy and ECIN are now Allscripts Care Management and Allscripts Post Acute Care.

Impact.MD is now Allscripts Document Management.

HealthMatics ED and EmSTAT are part of Allscripts ED.

Touchworks is now Allscripts Enterprise- made up of Allscripts Enterprise EHR and Allscripts Enterprise PM. That’s a mouth full.

eRxNow and Touchscript all fall under Allscripts ePrescribe.

HealthMatics Office, which was made up of HealthMatics EHR and HealthMatics Ntierprise will now be Allscripts Professional- EHR and PM.

So now we’ll start weaning people away from Touchworks and toward Enterprise.

I wonder how Microsoft has gotten by with calling that spreadsheet product “Excel” all these years?

ACE Wrap- Final thoughts from the Allscripts User Conference | Blog | Healthcare Informatics

Microsoft's Sphere display in action - Global Electronic Medical Records?

If you like Surface, you will no doubt love Sphere.  Ok is this the next way to view radiologyimage images or electronic medical records?  Sure could be interesting and hey why not some global e-prescribing while we are at it (grin).  It could certainly make for a very interesting document manager as well. 

Surface started the same way with coming out of the labs area so it will be interesting to see how soon Sphere makes it out there.  BD 

Sphere is a cousin of the Microsoft Surface tabletop computer, already being used in retail and hospitality settings. The underlying hardware for Sphere is sold commercially by Global Imagination of Los Gatos, Calif., but Microsoft researchers made numerous enhancements and developed specialized software. In a broader sense, the project reflects Microsoft's belief that many more surfaces will become computer displays, with embedded microprocessors, in the years to come. That view is championed by Craig Mundie, Microsoft's chief research and strategy officer, one of two executives filling Bill Gates' role at the company.

 

 

Video: Microsoft's Sphere display in action

http://research.microsoft.com/~benko/projects/sphere/

http://www.engadget.com/2008/08/14/more-on-microsofts-sphere-revealed-in-new-video-and-diagrams/

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...

It should be the discretion of individual physicians, not insurance companies or pharmacies, to substitute a branded biologic for a biosimilar, which goes back to putting the physician in the decision making process, not the non clinical analyzers.  While the search for "cheap" continues we will all be taking products with Asian or Indian technologies soon, and not American. 

imageThere are still quite a few biotech companies that go "bust" as well, so there's not always a guarantee until the clinical results are in, and with the use of genomics and smaller focus groups, this process has been sped considerably compared to how it was done in the past.  Candidates can be better defined even before participation begins.  

This is one delicate situation here, do we want to be the leaders and create our own solutions or end up being consumers of what is developed "cheaper" in other nations?  Big question, but then there also comes the balance of funding from grants and venture capitalists as well.  Private funding has made great strides available where grants are either not available or too complicated to qualify and secure. 

Thank goodness someone is making the effort to explain genomics to Congress, and and I hope they can grasp the concept instead of relying on the "cheap" business model that has been driving healthcare decisions for a very long time, and yes we need a happy medium along the line as well.  Robbing Peter to pay Paul went out years ago when it comes to biosimilars, so if not allowed, the higher priced brand names become unreachable for many.  Many create their own generics to compete as well as a way of lower costs, but still maintaining a cost recoverable amount of the market share.  BD 

Geoffrey Allan has been giving Congress a lesson in biotechnology. He's explained protein structures and how they work. He's reviewed how drugs are absorbed into the body.

"We've always supported a pathway," said Genentech spokeswoman Megan Pace. "We just want to make sure patient safety and data protection for innovators will be a part of the bill."

Because biosimilars aren't exact duplicates of the original drugs, they don't violate the original drug's patent, enabling legal distribution before patent expiration. As a result, the Biotechnology Industry Organization, as well as the handful of biotechs that control most of the market, supports a 14-year period to allow companies to recoup their investment and conduct further clinical trials to improve the product.

But the potential market is big. Four of the six FDA-approved drugs for multiple sclerosis are biologics. Treatment can cost a patient more than $30,000 a year, prohibiting many from obtaining drugs, said Shawn O'Neail, an associate vice president at the National MS Society.

Biotech Campaigns for Easier Access to Generic Drug Market - washingtonpost.com

Report Finds Patient Involvement Critical To Overall Care

This is something I mention quite frequently.  Here's a site whereby e-Patients can now compare notes on how to be a good e-Patient.  BD 

imageThe person who has the most at stake when it comes to healthcare decisions-the patient-should be involved in research, advocacy and all segments of the health care system, according to a key finding of a report released by The National Working Group on Evidence-Based Health Care.

Report Finds Patient Involvement Critical To Overall Care 

Departing scientist cites VC funds are short in Arizona

He is the co-founder and chief scientific officer of Navigenics.  BD

Gene tests one day will be as common as blood-pressure checks or cholesterol screens as tools that doctors use to help people fend off serious disease. At least that's the vision of scientists such as Dietrich Stephan. Stephan, who has served as the Translational Genomics Research Institute's deputy director for discovery research and director of the neurogenomics division over the past five years, will leave the Arizona research group for his own company, a San Francisco Bay Area consumer genomics firm called Navigenics.

Departing scientist cites funds

Drugs as good as stents for many heart patients

There was one exception and that was patients with severe chest pain fared better with angioplasty. So the question remains, drugs or angioplasty?

imageOne physician states though that some patients now may be given medications without adequate testing to show angioplasty can safely be delayed, so is the study a help or is it adding more gray area to the decision making process?  BD

People with chronic chest pain who are not in big danger of a heart attack now may have even less reason to rush into an artery-opening angioplasty: There's more evidence drugs should be tried first and often are just as effective. The slim early advantage for angioplasty at relieving pain in these non-emergency cases starts to fade within six months and vanishes after three years, according to a new report from a landmark heart study.

Drugs as good as stents for many heart patients - washingtonpost.com

Patients Fear Their Rapport With Genentech Is in Danger

Right now according to the Wall Street Journal, patients who have enjoyed an open relationship are worried that this could all change under management from Roche.  Is bigger always better?  Recently in the news Genentech is not happy with the offer and may hold out for more.  Anyone that has worked anywhere when mergers and buyouts take place know that everything does not stay the same, but what does and what does not, nobody knows.  BD 

While Roche Holding AG's recent bid for Genentech Inc. cheered investors, it had a more chilling effect on the patient advocates who have developed unusually close ties to the pioneering biotechnology company. Despite contentious battles over the price of the cancer drugs it has developed over the past three decades, Genentech has invited activists to confer on clinical-trial planning, peek at early study data, and sit in on meetings about manufacturing and pricing strategy.

Arthur Levinson, the company's chief executive officer, and other top managers regularly host meetings and lunches with patient groups. Indeed, just days after the Swiss pharmaceutical giant's takeover offer, an advocacy group for colon-cancer patients gathered for a meeting inside the walls of Genentech's South San Francisco campus.

Patients Fear Their Rapport With Genentech Is in Danger - WSJ.com

GINA DNA Law - What happens between now and May 2009?

Maybe this is a dumb question, but what does happen and what can the employers and insurance companies access between now and then?  Is this one of those "gray" areas we will have to deal with?  BD 

Once this law takes effect, it should remove the fear associated with genetic discrimination and benefit clinical research and health care delivery. GINAs health insurance provisions will take effect in May 2009; the employment provisions take effect six months later in November 2009. The Equal Employment Opportunity Commission (EEOC) is expected to release final regulations interpreting the law by May 2009.

Groundbreaking genetic non-discrimination bill signed into law | HemOncToday

IMedica not satisfied with current agreement with Misys Electronic Medical Records and looking to terminate the contract..

Dispute among the EMR/EHR vendors, and Misys in in the process of merging with Allscripts, so perhaps too much at once?  2 small sales of the rebranded software in the amount of time might give anyone's sales and marketing departments a little discontent.  BD 

Raleigh, N.C.-based Misys Healthcare Systems has announced receipt of a letter terminating a year-old agreement to market the physician software of iMedica Corp., Carrollton, Texas. Seeking to target smaller practices, Misys in August 2007 licensed iMedicas software and rebranded it as Misys MyWay. Available in remotely hosted and standalone versions, the vendor has announced only two sales of Misys MyWay. Pacific Ocean Pediatrics, a three-physician practice in Santa Monica, Calif., signed a contract in late 2007. In April, Daughters of Charity Health System began offering the software at a subsidized rate to Bay Area, Los Angeles and San Jose area physicians.

Misys’ Small Practice Apps in Limbo

Software that saves lives - Business Intelligence - one Neurologist discovers the secret...

Great article on a neurosurgeon taking the lead here with getting the hospital to embrace.  I don't know how any company of any size functions today without Business Intelligence software.  I still see it all the time though, working staff twice as hard, paying many extra man and woman hours for what a software program can do better in a fraction of the amount of time, but those same folks are still doing everything via Word Documents and spreadsheets.    Many hospitals now have invested in Business Intelligence software and this story is unique as the vendor working with the surgeon to tweak and give him the desired results.  The CEO of the hospital should love this guy.  Further reading on related articles here: 

http://ducknetweb.blogspot.com/2008/06/microsoft-releases-microsoft-dynamics.html

http://ducknetweb.blogspot.com/2008/05/nuance-radcube-new-business.html

Does Wall Street use business intelligence for healthcare analysis?  Yes...

Do Venture Capitalists like business intelligence software companies...Yes...BD

The statistics were telling: 15% to 20% of neurosurgery patients developed infections in the drains that neurosurgeons implanted to draw away fluids, a complication that not only threatened lives, but also led to hundreds of thousands of dollars in treatment costs annually.

That may not be surprising, but his choice of IT tools is: Stålhammar picked business intelligence software to improve patient outcomes and ultimately save lives.Stålhammar used QlikTech International AB's QlikView to analyze multiple databases containing patient information against established medical measurements and likely outcomes. This tool has helped the hospital reduce its rate of medical complications, sparing patients any additional pain and problems and eliminating the need for many costly tests and treatments.

Stålhammar worked with the hospital IT staff to develop the tool, turning to Johan Rylander, a solutions consultant at QlikTech, for support. Although Stålhammar's use of QlikView isn't typical, pulling together the application wasn't particularly tricky, Rylander says.

"All the data sources were already defined. Dr. Stålhammar already knew what he needed, and I helped him to translate his ideas," explains Rylander.

Software that saves lives - Network World

Clinical Trials Firm Buys Trials Clinical Trials Vendor

Some new integrated features will include voice response and Web-based patient recruitment services, electronic data capture and clinical data management software along with a full reporting system.  Voice response can make the reporting system easier for patients to respond and I am guessing the recruiting portion more or less speaks for itself with additional information available and perhaps some new ways of finding and locating potential participants. 

We have software to manage just about everything we do today and this looks like the business of clinical trials is getting a bit more organized along the way as their numbers continue to grow.  BD 

PAREXEL International Corp. has closed its acquisition of ClinPhone plc, a vendor of technology to manage clinical trials. The acquisition was valued at approximately $180 million. Waltham, Mass.-based PAREXEL is a contract research organization serving the pharmaceutical, biotechnology and medical device industries. United Kingdom-based ClinPhone, with U.S. headquarters in East Windsor, N.J., now is part of PAREXELs Perceptive Informatics technology subsidiary.

Trials Firm Buys Trials Vendor

Abbott and AstraZeneca Expand Relationship to Include Co-Promotion of CRESTOR(R)

As marketing intensity increases, there are some strange bedfellows emerging and who knows what could be the next affiliation we may read about?  Ask your Abbott representative about Crestor.  BD 

Under the terms of the agreement, Abbott will obtain the non-exclusive right to promote CRESTOR alongside AstraZeneca in the United imageStates, excluding Puerto Rico. Specific financial terms were not disclosed. CRESTOR is a once-daily prescription statin medication indicated for use as an adjunct to diet in the treatment of various lipid disorders including primary hyperlipidemia, mixed dyslipidemia and isolated hypertriglyceridemia, and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is available in a 5-, 10-, 20-, and 40-mg dose.

Abbott and AstraZeneca Expand Relationship to Include Co-Promotion of CRESTOR(R) - FierceBiotech

California Healthcare Foundation - Grants available to adopt HL7 Lab standards...

If you are a non profit hospital or healthcare association, well worth looking at as this can help pave the way to interoperability with electronic medical records.  BD

The California Healthcare Foundation in Oakland will offer grants to providers in the state to implement the new EHR-Lab Interoperability and Connectivity Specification, a national standard for the delivery of lab results from clinics to physicians. The foundation has committed $300,000 for the program and will award 20 grants of up to $15,000 each over 12 months. The foundation supported initial development of the standard, called ELINCS, before standards development organization Health Level Seven assumed continued development and maintenance.

California provider organizations eligible for a grant include hospitals, group practices, independent physician associations, community clinics, health plans and laboratories. The foundation has published a six-page request for proposals, available at chcf.org. Proposals are due Aug. 28

Grants Offered to Adopt Lab Standard

Hospital - Revenue is up, profits are down

Words of reality quoted by this hospital CEO, "There are too many variables involved until we go line item by line item", and that is certainly one big challenge as well.  Many hospitals have active fund drives in place as well as other sources of creating additional revenue compensation, such as clinical trials, grants, etc.  We have corn and beans on this list here too:)  How difficult has the process become?  BD

Mercer County Hospital reported gross patient revenue of $17,898,000 in 2008. "That's almost $1 million more than last year," said Mercer County Hospital CEO Tim Putnam, "and we didn't raise any rates. From a volume standpoint we did really well." Putnam added, "From an 'ability to collect' standpoint we are nowhere near where we need to be. Our net revenues are nearly $200,000 less than last year because of bad debt and contractual adjustments." The hospital is reporting a loss of $499,743 for the year.

The hospital's fund drive is at $667,143 in cash plus 22,135 bushels of corn and beans (mostly corn).

The Times Record Online :: Aledo, Illinois - News

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Should States have the final say On Genetic Testing?

This is indeed one controversial subject.  What is potentially behind all of this is that we don't have physicians linked in here.  When you stop and give this some thought, who do you want discussing your healthcare with you, your family practice doctor most of us would probably say, but what if your physician doesn't have the knowledge, where do you go then?  It comes down to a matter of trust.  Sure, you can go to the web and do your research and when this occurs, where does the trust and confidence go?  Good question. 

Do we have an government that is in tune with where the technology is going, well I don't believe so, or perhaps not blanketed enough to where they can understand the potential implications here.  Why require a prescription from a doctor who may not know the full story?  On the other hand, is this an action to stall the progression until both the medical community and consumers are educated to where the information given will be helpful?  One thing odd I find that is if one is arrested, you DNA is up for grabs pretty much, so again if technology is being used to solve crimes, why do we back peddle it for the interests of better healthcare?  Are we pro-active or re-active? 

Everybody is in control here, yet nobody is in control.  Part of the issue is the overall community not being well read.  I try to encourage people to take 10 minutes a day to read, other folks in other countries do this and even learn how to speak English via the Internet, so what's up with society here in the US, do we not like to read? In the world we live in today, ignorance is no longer bliss by any means.  BD

On June 9 California sent letters to 13 genetic-testing companies ordering them to "cease and desist performing genetic testing without licensure or physician order." Some of the companies have since stopped offering direct-to-consumer tests to Californians, while others insist that they are already in compliance with the law and continue to operate in the state. New York State similarly warned companies this spring that they need licenses to accept DNA samples from the state's residents.

California State Actions Point To Need For Federal Leadership On Genetic Testing

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The unfriendly skies of the US healthcare system

When I read numbers and studies such as this, it is no wonder we are lagging behind other countries in healthcare.  First of all, if it is not affordable and accessible, the consumer will not go, especially in the area of chronic diseases and especially in preventative medicine.  We have a very unfriendly medical system in existence today, and this does not mean the doctors and medical staff that care for us, it's rather the system that they and us, as consumers have to work within.  As time marches on, the system continues to even get to be more "unfriendly" as the parameters and stipulations of healthcare, and who's going to pay the bill, is getting so complicated.  image

You know I have to say myself I could be right in the group too as with the added pressure today of the business world, much gets put on the back burner, which in years past did not.  It amazes me how we keep looking for bandaids for a big gaping wound that needs attention today.   As we have seen, denial doesn't work as it's not going away any time soon, the the whole theory of better preventative healthcare is not looking very good these days.  Sure there are rules and regulations, but I ask this, have the rules and regulations become so complicated and economically based that it is now having the opposite effect? 

It somewhat comes down to this, "there are more important things in life than oneself having to be right all the time, but, (BIG BUT) for goodness sakes, do the right thing".  It appears there is so much focus on economics of healthcare and many egos that are flying around in reference to who's the king of the hill with their ideas, that we have lost our focus on what is really important, "doing the right thing".  The answer lies in teamwork and not necessarily individual efforts as we are all in this together.  BD  

Nearly a quarter of Americans have reduced the number of times they see their doctor because they want to save money in these tough economic times, according to a survey released Tuesday by the country's state insurance regulators.

Eleven percent of those surveyed also said they had cut back the number of prescription drugs they take or the dosage of those medications to make the prescription last longer.

22% of Americans surveyed cut visits to doctor

OralDNA to Distribute Periodontal Disease Genetic Test in US - DNA at the Dentist's Office

image Dentists now are coming in to the fold of DNA genomics tests.  This test is very specific to assess risk for periodontal disease, so as a younger patient, as chances are as we age if we are at risk we may already have this, this could be a good indicator for the dentist to have in the knowledge bank to be aware that you could possibly be a strong candidate for developing the disease. 

As biotech continues to grow in many areas, who's going to want have your DNA, it is still a choice by the end consumer, but as you can see our DNA someday could be stockpiled in more than one place.  BD

NEW YORK (GenomeWeb News) OralDNA Labs has licensed the rights to sell an Interleukin Genetics test that assesses the risk imagefor  periodontal disease, Interleukin said Wednesday. Under the agreement, the oral diagnostics company has acquired a non-exclusive license allowing it to market, sell, and distribute Interleukin Genetics PST Genetic Test to dental practices in the US.

GenomeWeb News: OralDNA to Distribute Interleukin's Periodontal Disease Genetic Test in US

Edible 'Sensor' Could Alert You to E. Coli - Silk in my Spinach?

Hey is there silk in my spinach?  We know we all like to wear it, but will we be eating it sometime in the near future?  A couple scientists have already created optical components, like lenses and sensors, out of protein from silk.  It is biodegradable.  Many of these stories sound like science fiction and myself I used to consider them the same, but with today's technology, you just don't know what may roll out next. image

The Defense Department's Advanced Research Projects Agency has an investment in this technology as well.  So perhaps down the road our vegetables may have a warning sensor, letting us know if the vegetables we all love are safe from bacteria.  This research is going on at Tufts.  BD 

Silk from the humble silkworm has been used by humans for thousands of years, mostly to create textiles, but it appears that this remarkable material is on the verge of entering a dramatic new role. It may some day save your life.

If the sensor detects E. coli, for example, the film would change colors to whatever color reflects the presence of the bacteria. If it's red, the film would turn red, as in a litmus test.

ABC News: Edible 'Sensor' Could Alert You to E. Coli

Cancer Physician Invents Test For New Drugs That Cut Off Tumor's Blood Supply - Huntington Beach, California...Personalized Medicine

Tumor Cell Profiling...the tests show if your cancer cells were killed by exposure to one or more of the 20 or so different anti-cancer drugs that might otherwise have been considered as possible treatments for your type of cancer.  A test that can help determine which cancer drugs would appear to be the best treatment plan.  He has an office and lab and is currently providing tests in this area.

To have the test done, first of all you need a biopsy to delivery the cells for the study.  Fees for a complete 20 to 25 drug Functional Tumor Cell Profiling analysis will be in the neighborhood of $5,000.  The procedure is covered by Medicare and some insurers as well.  BD 

image Today's online edition of the  Journal of Internal Medicinereports discovery of the first practical laboratory test to guide the use of new-generation drugs that kill cancer cells by cutting off their blood supply. The new test, called the Microvessel Vascular (MVV) assay, was developed by Larry Weisenthal, MD, PhD., a medical oncologist who operates a cancer testing laboratory in Huntington Beach, California. The test works by measuring drug effects upon endothelial cells which make up blood vessels. Its use could prolong lives, save money, and spare patients exposure to harmful side-effects of ineffective chemotherapy treatments.

According to Dr. Weisenthal, therapeutic levels of ethanol in the bloodstream theoretically could be achieved simply by drinking wine or another alcoholic beverages in prescribed doses concurrent with receiving angiogenesis-inhibiting drugs. The concept might please some patients and alarm others but Dr. Weisenthal finds support in actual case studies reported in the medical literature. However, he warns that further clinical studies are required.

Dr. Weisenthal says that he would like to see the test become available to patients worldwide through service agreements with larger laboratory companies or with a biotechnology company which might develop a testing kit for sale to hospitals and laboratories. He also would like to license the test to pharmaceutical companies for use in new drug development.

Cancer Physician Invents Test For New Drugs That Cut Off Tumor's Blood Supply

http://www.weisenthalcancer.com/index.htm

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CVS Goes for Longs - Another Step in Drugstore Consolidation

image One reason stated is convenience, more on every corner, like the gas stations.  To take advantage of some of the other low cost benefits, there may be a longer driving distance.  A while back I had a conversation with someone from CVS, and there are shoppers who visit every store, one for a prescription drug or item on sale, and one for something else, in other words drop your prescription off at WalMart, go shop at CVS for the advertised specials, come back and pick up your prescription.  There' still money to be made in non prescription items, like a new patio set for the deck.  BD 

Also the larger the chain, the larger potential bargaining power with the Pharmaceutical companies on pricing.  BD 

CVS Caremarks acquisition of Longs Drug Stores, a pharmacy chain that's big in California, Hawaii and Nevada, is the latest example of the push by chain drugstores for scale.

Health Blog : CVS Goes for Longs, Another Step in Drugstore Consolidation

FDA Grants Approval To Evera Medical's FulFil Lip IDE Application

imageIf you are in the market looking for a Lip Implant, the FDA has just cleared a solution.  The procedures uses saline so it is safe for the body.  Video at the site to see how the procedure is done.  BD 

 

Evera Medical announced that the U.S. Food and Drug Administration has granted conditional approval of the Company's investigational device exemption (IDE) application for its FulFil Lip cosmetic imageaugmentation implant. This approval allows Evera Medical to assess the safety and effectiveness of the FulFil Lip implant in patients undergoing aesthetic lip enhancement. Enrollment into the study, named EIFFEL (Evera Implant --  FulFil -- For Enhancement of the Lip), is expected to begin within 30 days.

FDA Grants Approval To Evera Medical's FulFil Lip IDE Application

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Pharma sales to physicians: emotions beat evidence

image Some things in sales don't change no matter what field you are in and Pharma is no different, sales are made by building relationships, in other words, people do business with people they like, so the peer articles maybe could be just a little off target.  I spent over 20 years in outside sales in another field, and that is exactly how it is done.  BD

So much for peer-reviewed journal articles. According to the results of the national Physician Engagement study by PeopleMetrics Rx, "emotional components such as friendship with the reps are the strongest indicators of fully engaged physicians." In this context, the phrase "fully engaged" is one that means "very likely to prescribe." The study included Pharma companies AstraZeneca, Bristol-Myers Squibb, Janssen, Eli Lilly and Pfizer and included 500 psychiatrists and primary care physicians who regularly prescribe atypical antipsychotic medications.

Pharma sales to physicians: emotions beat evidence - FiercePharma

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Attending any Medical Conventions - Try the Sheraton Hotel to experience some new technology, Surface from Microsoft

This can be handy if you don't have one of your favorite devices handy to locate places to east, movies, etc.  So far there are 5 locations that are set up.  BD  image

WHITE PLAINS, N.Y. and REDMOND, Wash. — Aug. 13, 2008 — Sheraton Hotels & Resorts and Microsoft Corp. today introduced an entirely new hotel guest experience with its debut of Microsoft Surface, Microsoft’s first commercially available surface computer. Featuring easy-to-use technology and a natural way of accessing information, Surface units will be placed in the lobbies of select Sheraton hotels in Boston, Chicago, New York, San Francisco and Seattle. Microsoft Surface breaks down the traditional barriers between people and technology, providing simple and instant access to information and entertainment. Sheraton will be the first hotel to offer Microsoft Surface, creating a new Sheraton brand experience that will bring interaction, connectivity and a social setting to the lobby, providing guests with an entirely new way to explore local tourist highlights and enhance their hotel stay. 

Microsoft Surface is a 30-inch display in a tablelike form factor that several guests can use simultaneously. The intuitive user interface works without a traditional mouse or keyboard, allowing people to interact with content and information in a more natural and familiar way, by using their hands and gestures. Sheraton will unveil Surface today at five hotels: Sheraton Boston Hotel, Sheraton Chicago Hotel & Towers, Sheraton New York Hotel & Towers, Sheraton Gateway San Francisco Airport Hotel and Sheraton Seattle Hotel.

 

http://www.microsoft.com/Presspass/press/2008/aug08/08-13SheratonMSSurfacePR.mspx?rss_fdn=Press%20Releases

Schering-Plough Expands Its Presence in China

The company has had a presence in China since 1994.  BD 

KENILWORTH, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that it has expanded its presence in China and established Shanghai Schering-Plough Pharmaceutical Co. Ltd., as a wholly owned operation based in Shanghai through the acquisition of the shares of its former joint venture partners. "The actions announced today are part of Schering-Plough's long-term global geographic expansion strategy," said Fred Hassan, chairman and chief executive officer, Schering-Plough Corporation. "Investing in the Asia-Pacific Region, and especially China, represents another step in our journey to transform Schering-Plough into a global high-performance health care company. With a long-term presence in China, Schering-Plough now takes a significant step forward in its strategic development to further build growth and strength in this important market.

Schering-Plough Expands Its Presence in China, Enters Next Stage of Development - FierceBiotech

Study finds 140,000 bad reactions to antibiotics at the ER Room

With allergies to selected antibiotics, this is an area where personalized medicine can be of help, find out the tendencies before beginning a treatment plan.  BD 

WASHINGTON - Bad reactions to antibiotics, mostly allergic ones, send people to U.S. emergency rooms more than 140,000 times each year, government researchers reported on Wednesday. The findings offer another reason for doctors to limit their use of the drugs, which are overused in the United States, the team at the U.S. Centers for Disease Control and Prevention said.

Study finds 140,000 bad reactions to antibiotics - Health care- msnbc.com

Changes Brewing on Capitol Hill for Health Insurance

This is the first I have seen of this type of proposal, your health insurance being included on your tax return.  Gee...will the IRS do the collecting?  There's more to the story but from one stance here, it's a change from paying premiums to the insurance companies.  BD 

The bill, known as the Healthy Americans Act, would require everyone to buy health insurance. But instead of sending a check to the insurance company, the premium for basic coverage would be tacked onto your federal income tax. You would choose from health plans offered by private insurers in your state or region. If you wanted to buy a plan that covered more than the basics, you'd pay extra.

Health Blog : Changes Brewing on Capitol Hill for Health Insurance

Mad Cow Rules Hit Sperm Banks' Patrons - you can't always get what you want...

It states that the odds of getting mad cow disease from sperm are few and far between, but I guess the the FDA is recommending against imageimporting sperm from any donor who has lived in the United Kingdom or France for more than three months, or elsewhere in Europe for more than five years, since 1980.  Perhaps she might have some luck finding a Viking baby donor from here in the United States. 

Nordic frozen semen appears it might be going up in price based on supply and demand here in the US.  BD

The sperm bank had run out of vials from Peterson's donor and could not replace them, because of restrictions health officials have instituted to protect Americans against the human form of mad cow disease. Since May 2005, the United States has effectively barred sperm banks from importing from Europe for fear it might spread the brain-ravaging pathogen that causes the affliction.

Before the restrictions went into effect, two sperm banks -- California Cryobank in Los Angeles and Cryos International in New York City -- imported sperm from Denmark. The Nordic donors were popular because of their blue eyes and blond hair, and their tendency to be tall and have advanced degrees.

Mad Cow Rules Hit Sperm Banks' Patrons - washingtonpost.com

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Sanofi-Aventis Sues Apotex Over Taxotere US Patents

The patent is stated not to expire until 2010 and this will put a 30 hold at the FDA to grant approval.  This one should prove interesting to follow and see where the infringement occurs.  BD

LONDON -(Dow Jones)- Sanofi-Aventis SA (SNY) has launched a legal action against Canadian generic drugmaker Apotex Inc.,  which is planning to sell a low-cost version of cancer drug Taxotere in the U.S., a spokesman for the French pharmaceutical company said Tuesday. In a lawsuit filed Aug. 8, Sanofi-Aventis claimed that Apotex has infringed two U.S. patents of the drug, which in 2007 reported sales of EUR1.87 billion and is Sanofi-Aventis' fourth best-selling product.

 Taxotere is used to treat breast, lung and prostate cancer.

UPDATE: Sanofi-Aventis Sues Apotex Over Taxotere US Patents

Beat Diabetes - Not!

This was too good to pass up!  BD

image 

http://pharmagossip.blogspot.com/2008/08/diabetes-fail.html

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Kaiser and Stanford get $3.89M to study heart disease with linked medical records - California

If you belong to Kaiser in northern California, Stanford Medical will now be able to see your medical records for the purpose of studying imageheart disease.  It doesn't say if the records will be anonimized or not.  Stanford will have access to 3.3 million records to study what is working and what is not for heart disease.  Treatment plans, including prescription drugs and devices, such as stents and defibrillators, will all be scrutinized along with open heart surgery cases.  BD   

The new center will be called The American Heart Association - Pharmaceutical Roundtable Outcomes Research Center. The heart association has also provided funds to create similar heart disease research centers at Duke University and at UCLA. The Kaiser and Stanford researchers will use Kaisers patient-care data in their studies, linking for the first time medical databases for all of Kaiser Permanente's 3.3 million Northern California members.

Kaiser and Stanford get $3.89M to study heart disease - East Bay Business Times:

BIO Chief on the Wisdom of Giving Money to Democrats and a few other matters

Discussed here is the recent law in Massachusetts relative to gifts, etc. just recently passed.  Being the CEO of BIO, the biotech industry trade group, of course there's an interest in not having funds diminished, but also addresses the interest of the public.  With all the recent Pharma/biotech mergers, buyouts, etc. is this the same old game in place with the exception of Biotech now more or less ruling the roost where the drug companies had full reign at one time?

Investments and funds to keep research and development are important and vital to keep the system going and alive.  As the field continues to grow and clinical trials with smaller groups make information more readily available, faster than the methodologies have allowed in the past, it will be interesting to see how this evolves.  With DNA testing, which I am assuming every test, no matter where it is done, should be the same or very similar to one done at another facility given the same set of circumstances, how is the competition going to factor here.   Will all genomics tests be equal?  It's too early in the game to go there yet, but it will go there at some point in time.

In the meantime, Biotech continues to lobby our Congressmen.  The FDA is mentioned here with needed the best scientists around, and nobody can question that decision for one minute, but deep in the heart of Congress where decisions are made, we still have many who are still behind the times as recent members of Congress have stated openly themselves, so how this all plays out remains to be seen.  There's no secrecy anymore and transparency is the name of the game.

"What goes on the Internet, stays on the Internet". BD 

That's the view of Jim Greenwood, CEO of BIO, the biotech industry trade group. Unfortunately, he told us during a recent chat at Health Blog HQ, bad policy comes more easily than good policy.

Health Blog : BIO Chief on the Wisdom of Giving Money to Democrats