Leading Medical Groups Advise Against Avandia – FDA to Research – Education Needed

I will once more mention a potential change of paradigms here with educating the public.  Each patient who took the drug is unique.  Do we have any information on other drugs they were taking at the same time?  Groups will continue to advise against the use until the full facts are known, and all we know now is there were 14 people with complications, 12 with liver failures.

Again, it goes back to how and where the medication was prescribed and the consumer/physician knowledge of the drug.  Could this have been given to patients, perhaps some in an ER room where credible information can be sketchy and non existent?  Was there some valuable information missing that could have been used?

Personal Health Records along with electronic medical records used in the office could help with some answers.  The reason I am so high on personal health records from Google and Microsoft HealthVault is that they are a “portal” for information.  Let’s face it, when looking at a drug, the potential side effects, you can get lost going all over the web and the PHR along with your records can bring this information all under one roof.  The YouTube videos that offer information are great, but most don’t even know they are there, Pharma videos, and FDA videos included, so if very few know the exist and find them, what have we done here other than fragment some more information into an already over bludgeoned healthcare information system, very confusing and difficult to mine and deal with. 

We can’t keep diagnosing/treating from the hip as there is just too much information available that should not be overlooked when it comes to pharmaceuticals today.  As consumers, it doesn’t do any good to blame someone else if you are dead because it doesn’t make much different at that point, the damage is done.

So once more some nice grants and big Pharma participating in the education process would really be a good thing and start in house with your own management and employees to understand the value and how it works.  If big Pharma could set themselves aside from just straight marketing and invest in their own employees for a good start, think of what an impression this will make on the public. Do I feel it’s ok to trust Google and Microsoft?  Let me put it this way they both protect the enterprise and server times up are 99.9% and shoot they both give away a lot of software for free, so why not, as neither one owns any interest in insurance companies and both are working towards the goal of better health care without a “risk management” sign hanging on the front door.  I post more security breach stories on government and small entities these days and can’t remember the last time Google or Microsoft were an issue.

So back to the point of this entire issue, do you not think a change in paradigms might be in order here to join the team in the effort of curing cancer and other diseases with promoting better education instead of the television commercials we see day in and day out, perhaps a few less of those and more efforts put where education is needed, at the point of care. 

Use the vendors who are working with the Personal Health Records accounts and get connected so the individual has one place to go when they need specific advice instead of having to spend time mining the web, use PHRs in house to understand the concept first, Kaiser is.  The portals make it simple and easy and one source to find all.  image

Big Pharma may have fewer issues like this and happier consumers all over if they all joined in with education at the point of care and less emphasis on straight marketing, after all their employees are human too and might like the same type of concern and help internally.  The education of personal health records and the value they offer is needed everywhere from the consumer, to the hospital, the physician, and so on.  I go in to physician offices where medical assistants have no idea what a personal health record is, and perhaps the physicians as well.  Hospital personnel too, they have no clue, so this could be one huge jump for big Pharma in joining the team with a focus toward safer and better use of the medications they manufacture, so don’t miss the boat, education is the name of the game and it is free, all that is required is a little time.  BD   

WASHINGTON -- The clouds around GlaxoSmithKline PLC's diabetes drug Avandia darkened, with leading medical groups in the U.S. and Europe calling on doctors not to use the former top-selling drug.

GlaxoSmithKline said it hadn't yet looked at the Public Citizen petition. The company said, "We do not believe there is a connection between liver toxicity and this medicine." It said Avandia is safe and effective when used appropriately.

The FDA said it will carefully review the petition. FDA officials have said there is a split within the agency about whether to pull Avandia off the market or allow it to stay but with stronger warnings.

Leading Medical Groups Advise Against Avandia - WSJ.com

Washington University scientists first to sequence genome of cancer patient

10 genetic mutations were found in the patient's tumor and virtually every cell in the tumor sample had nine of the mutations. 

“What's striking about the new research is that the scientists were able to sift through the 3 billion pairs of chemical bases that make up the human genome to pull out the mutations that contributed to the patient's cancer.”

Amazing, that the entire sequencing was processed and more information in this area will lead to finding cures and genetic warning signs for cancer and where the potential lies and again what medication in time will prove to benefit.  BD 

image

Washington University scientists first to sequence genome of cancer patient For the first time, scientists have decoded the complete DNA of a cancer patient and traced her disease - acute myelogenous leukemiaterm - to its genetic roots. A large research team at the Genome Sequencing Center and the Siteman Cancer Center at Washington University School of Medicine in St. Louis sequenced the genome of the patient - a woman in her 50s who ultimately died of her disease - and the genome of her leukemia cells, to identify genetic changes unique to her cancer. The study is reported in the Nov. 6 issue of the journal Nature.

It sets the stage for large scale sequencing of cancer genomes and unraveling the mystery of cancer."

The researchers discovered just 10 genetic mutations in the patient's tumor DNA that appeared to be relevant to her disease; eight of the mutations were rare and occurred in genes that had never been linked to AML. They also showed that virtually every cell in the tumor sample had nine of the mutations, and that the single genetic alteration that occurred less frequently was likely the last to be acquired. The scientists suspect that all the mutations were important to the patient's cancer.

Previous efforts to decode individual human genomes have looked at common points of DNA variation that may be relevant for disease risk. What's striking about the new research is that the scientists were able to sift through the 3 billion pairs of chemical bases that make up the human genome to pull out the mutations that contributed to the patient's cancer.  Of the eight novel mutations discovered, three were found in genes that normally act to suppress tumor growth. One of these mutations is in the PTPRT tyrosine phosphatase gene, which is frequently altered in colon cancer.

Another gene alteration appears to affect the transport of drugs into the cell, and may have contributed to the patient's chemotherapy resistance.

Washington University scientists first to sequence genome of cancer patient | Cancer Forums and News

Fred Baron Dies, Despite Being Given Tysabri

Even folks with money and in high positions have problems getting access to cancer drugs, as you can read below, and this was not an issue of not being able to afford the medication.  When you read items as such, it makes you stop and think how precious life and healthcare really is.  BD 

Fred Baron, the wealthy Texas trial lawyer and prominent Democratic fundraiser linked to the John Edwards mistress scandal, died yesterday at 61, the Associated Press reports.

Baron had been diagnosed with multiple myeloma, or bone marrow cancer. His death comes just two weeks after he obtained Biogen’s Tysabri following a public plea by his son, Andrew, who had called the drug “last chance effort for life.”

http://www.pharmalot.com/2008/10/fred-baron-dies-despite-being-given-tysabri/

Massachusetts Desperate Hospitals - MetroWest Medical Center's vital signs are weak

According to the article, there’s still time to save the hospitals and no plans on closing at this point, but it’s the same thing faced all over the US, no money, and 50% of the hospitals in the US border on solvency, and sure hate to see that number rise by any means.image  Growing the business saddled with low reimbursements is not getting the job done.

Unfortunately, there’s a lot of related reading on this matter on the series I did called “Desperate Hospitals” over the last couple months.  BD

FRAMINGHAM — MetroWest Medical Center executives held a meeting with legislators and business leaders yesterday to tell them the institution's two hospitals are losing money and need help remaining viable.

While there are no plans to close the Framingham Union and Leonard Morse campuses, executives said the two facilities lost a combined $4.2 million this quarter, including operating expenses that ended $360,000 in the red.

"This institution is unfortunately under financial duress," said Joseph Mullany, regional president for parent company Vanguard Health Systems.  "The more I grow the business, the more I lose," he said. "So something has to change."

Related Reading:

Desperate Hospitals: Chicago Hospital Hangs For Sale Sign

Desperate Hospitals - Hawaii- What is happening to our Hospital System?

Desperate Hospitals - August 29 (Continued)

Concerns Over Large Not-for-Profit Hospital System

Desperate Hospitals - Grady's financial cure in question

More Desperate Hospitals - Miami, FL and Cape Cod, MA

A hopeful prognosis - Desperate "California" Hospitals

Desperate Hospitals - Century City Doctors Hospital (Los Angeles) begins shutting down, others file Chapter 11 to reorganize

New New Jersey law to pinpoint financially troubled hospitals - "Desperate Hospitals"

Desperate Hospitals? (As Featured today in the WSJ)

The battle of the medical bills where nobody but the insurers win

Hospitals protest new California rules on patient balance billing

Cape Cod hospital gets $10M gift

Bankruptcy Bug Hits Hospitals – Desperate Hospitals

Desperate Hospitals – September 2008

Desperate Hospitals: Hospitals in Hands of Voters - Arkansas

http://www.metrowestdailynews.com/lifestyle/health_and_environment/x2081380321/MetroWest-Medical-Centers-vital-signs-are-weak?view=print

Cardo Medical Announces FDA Clearance Of The Align 360 Total Knee System

The new knee won’t be available until next year; however the web site states that the device will be able to be customized, in other words more of a custom fit instead of a one size that fits all.

Hopefully the new design might offer a little longer lifetime as well.  BD 

 Cardo Medical (OTC Bulletin Board: CKST), a company engaged in the development of orthopedic medical devices, announces the FDA 510k clearance of its Align 360 Total Knee System. The Align 360 Total Knee System is planned for commercial release during the second quarter of 2009. Cardo Medical's innovative Total Knee System is the flagship product within its Align 360 image platform which has already received FDA clearance for its Uni-Compartmental and Patello-Femoral systems. All three systems feature a unique modular approach and common instrumentation system imagewith a revolutionary concept designed to deliver simplified, reproducible surgical outcomes. Cardo Medical's Uni-Compartmental System, which was the first product release within the Align 360 platform, has been used successfully in over 500 surgeries to date.

The Align 360 Knee system is an innovative concept which allows the surgeon discretion in treating stages of degenerative knee conditions including unicompartmental, bicompartmental and tricompartmental disease with a matched instrument and component heritage. . Our novel instruments all share a common foundation and provide simple and easy to use tools for reproducible and accurate results. The components are high performance cutting edge designs to allow patients to achieve superior clinical outcomes.

Related Reading:

DigiMatch(TM) ROBODOC(R) Surgical System Receives U.S. FDA 510(k) Marketing Clearance

Want to Watch a Live Webcast of a Total Knee Replacement?

Cardo Medical Announces FDA Clearance Of The Align 360 Total Knee System

Schwarzenegger Will Propose Major Cuts to Health and Human Services on Top of Education Cuts

Not to fault the governor here totally, he has to work with what the legislature put in place and we all know what a battle that was with hospitals, nursing homes, etc. that were put on hold this year with no payments for 3 months until a budget was created.

Risk management runs healthcare and it appears it also runs state budgets these days too.  BD 

Saying the budget situation is “unprecedented”, high level Schwarzenegger Administration officials said today in a conference call to health and human services advocates that the Governor will propose major cuts to health and human services as part of a package of proposals to address the growing State budget crisis that he wants the Legislature to approve when they meet in special session next week. Administration officials also said that the Governor will also propose ways to increase the State’s revenues, including proposals to help Californians who have lost jobs or face foreclosure but that every budget area will face reductions to control growth in spending. No details on the spending cuts or revenue increases were provided.

Bradshaw said that the State’s revenue loss is “far beyond what we expected” and that the budget shortfall is significantly larger and “dramatic”.

http://www.californiaprogressreport.com/2008/10/schwarzenegger_99.html

Painbuster System from B. Braun – Catheter system to delivery pain relief directly to the wound area

This has been started in the UK and could certainly reduce the amount of pain reliving pills needed post surgery and the entire unit is disposable, so the medication goes to where the pain is instead of having to go to our brains first.  No word yet on when we might see this in the US. 

With emergency situations I could see this technology being very valuable, again it has the potential to eliminate the need for additional painkillers like morphine and others.  BD 

PAIN could be a thing of the past for hospital patients, and more money could be available to improve healthcare facilities across the UK, say manufacturers of a groundbreaking new pain-relief system. The Painbuster System from Sheffield-based B Braun Medical uses a pump and catheter to deliver local anesthetic directly into a wound area, providing rapid and effective pain relief for up to five days. Makers say patients can recover faster from surgery using the tool as they will have significantly-less need for painkillers such as morphine, which can have unpleasant side effects. This will cut the time patients have to spend in hospital after treatment and free up valuable resources.

“The system is designed to infuse local anesthetic directly into the wound to provide effective pain relief without the need for opiates and the technique itself is quick and easy to use and the system totally disposable after use.”

Healthcare Equipment and Supplies

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GSK's Witty wants more funds for FDA – Why not step up to the plate with some grants and join the General Education process

This actually a pretty good start and I have had my own campaign of sorts going on with getting the FDA up to speed, and they are definitely having to play catch up, as are some other government agencies.  In prior posts I had written that some clinical studies were still being written in long hand and even made a call out to Intel to at least get some inexpensive “Classmate” computers to the agency if cost were an issue with budgets.  image

On the other hand, I would also like to see big Pharma contribute to the education process of the consumer.  They spend plenty on ads on television to sell and of course there is always the charitable sides of big Pharma, so why not start investing in the consumer, us who takes those pills.  I know I harp on this a lot, but big Pharma could certainly look like a shining star if they would contribute to drug safety.  So what does this mean?  Well some nice grants to educate the public on Personal Health Records and the importance of having one set up would be nice, and it’s not just the consumer who needs the education, it’s hospitals, doctors, everyone all the way around.  You have to go where the resources are available to educate the public, and the resources are here, just that very few have realized this. 

Would big Pharma like to make sure the side effects are taken seriously and avoid lawsuits, well personal health records are the bit shot at this, and drug interactions are part of the program.  I don’t think that there is any ER physician around that would not value this information up front, so come to the “Education” table here and join the group.  It is all a team effort and instead of all the questionable marketing that is done on television, help out with making sure the drugs and products produced are safely administered and get some grant money out there where it is needed. 

Technology in healthcare is moving at a very rapid rate and the more education and funds available to educate everyone all the way around, the better results we will have, and perhaps start with the FDA on making sure they have the funds and staff to work as a partner too, so go the next step with partnering for better health care education, as the Personal Health Care records are the gatekeepers to success all the way around, they are more than just records, the integrated information included educates at the same time.  A question I ponder and wonder about, does big Pharma recommend personal health records internally for their employees and what does the FDA do for employees internally? Is this a “do as I say” and not a “do as I do” situation?    Good place to start is always the “internal sale”, and that way you know the value and what’s going on, again we all want safety with our medications and certainly want to avoid any bad interactions. 

There should be immediate on going education at hospitals, pharmacies, physician’s offices, consumer outreach programs helping move this education process and nobody seems to be getting it.  BD 

It must be the day for CEOs to chat. The Financial Times sat down with Andrew Witty chief of GlaxoSmithKline, and his words for the day were flexibility (on pricing) and diversification (into generics and new acquisitions).

The FT practically invited Witty to thrash the FDA for its newly tough stance on new drug approvals, but he demurred, saying that the agency's attitude reflects society's attitude. And that attitude, for now, is anxious. So Pharma needs to focus on delivering more info, he said. And the FDA definitely needs more resources to do its job well.

Related Reading:

Medicine is a Low Tech Business - Clinical Studies still done on paper too!

FDA Reform Planned

FDA Head: We're Boosting I.T.

Study Calling For Medical Device Information To Better Serve Patients And Doctors from the FDA

GSK's Witty wants deals, more funds for FDA - FiercePharma

E-Prescribing Reminder – Effective January 1, Medicare will pay 2% bonus to those who use a “Qualified” program or system

A qualified system is not faxing!  Many offices who are set up with an EMR or EHR are already covered and are either set up and ready to go or have the capabilities.  For those who are not, there’s a permanent link on this page to NEPSI, the free e-prescribing initiative where you can sign up and get started.  If you are still using paper records, you can begin e-prescribing without having an electronic medical records system.  Also, these records can be imported in to Google Health personal health records so the patient will have a full listing of all their medications. 

As we all know, private insurers usually take the stance and follow in the direction of Medicare on issues as such, so if you are not set up and need an avenue to get started, check out the NEPSI initiative here if you want to gain the additional 2% compensation being offered by Medicare starting on the first of the year. BD

The Medicare program in 2009 will provide physicians with a financial incentive to use electronic prescribing in hopes of boosting the efficiency and safety of care. Physicians and other clinicians who adopt and use qualified electronic prescribing systems to transmit prescriptions to pharmacies may earn an incentive payment of 2% of their total Medicare allowed charges during 2009. This incentive is in addition to a 2% incentive payment to those who successfully report measures under the Physician Quality Reporting Initiative. In addition, the Centers for Medicare & Medicaid Services will implement a 1.1% Medicare fee schedule hike in 2009 as required by the Medicare Improvements for Patients and Providers Act of 2008.

Medicare Outlines e-Rx Incentive

CVS/Caremark join the Generic Discount Club – Connect information to Personal Health Record Accounts

$9.99 for 90 days with enrollment with the Health Savings Pass

CVS becomes the latest retail drug chain to jump on the bandwagon, pretty close in comparison, except you need to join the Health Savings Plan. The plan is primarily created for cash patients but anyone can benefit so if you have a $25.00 co-pay for example, pay cash and forget the insurance card. Being this is an annual fee for $10.00 I am assuming this will put you into a data base so perhaps the prescription imageinformation will be captured for the insurers. Other stores when you pay cash do not capture this information imageand send back to insurance companies. I wrote a post about that issue a while back, check under related reading for details on how this works.

The one thing different that I am not sure about is a 30 day prescription so the pharmacist might be able to clarify the information on this situation but I would think a 30 day prescription, as you may not need 90 days might fall into the same category for pricing. You will also get a 10% discount at the Minute Clinics located in some of the stores.

Also the information can be imported into your Personal Health Records, Google Health and Microsoft HealthVault. The link to the PDF showing all the generic drugs offered at the discounted rate has been added to the site, and it took me a few pages to locate the direct link myself, but it is there.

A while back I did a short interview at one of the Minute Clinic stores here in California and you can find the details under the related reading section below. BD

Enrollment into the CVS/pharmacy Health Savings Pass is easy and costs only $10 annually, per person. Whether you have limited prescription insurance or no coverage at all, you can sign up today for the CVS/pharmacy Health Savings Pass and start saving immediately.

It’s not an insurance plan, but a prescription savings pass that allows you to save on the medications you and your family need. Plus, you’ll receive 10% off MinuteClinic services* inside select CVS/pharmacy stores.

Here’s how you can save with your Health Savings Pass:

• Pay only $9.99 for a 90-day supply of over 400 generic prescriptions.
• 10% off at MinuteClinic on any regular priced health service or screening*
• Save at one of our more than 6,300 CVS/pharmacy locations nationwide.

CVS Caremark will make prescription histories from its retail and mail order pharmacies, and medical records from its in-store MinuteClinics, available to consumers via a HealthVault account from Microsoft Corp.

The alliance means consumers with a HealthVault account will be able to download into their personal health record prescription histories from CVS and records of visits to a MinuteClinic, which uses an electronic health records system.

Related Reading:

Patients Seek Financial Aid to Buy Medications

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

Google Health Vendors you can connect with and import records – Personal Health Records

Minute Clinic Visit - Huntington Beach, CA

CVS to Offer Records Via HealthVault

http://www.cvs.com/CVSApp/promoContent/promoLandingTemplate.jsp?promoLandingId=1046#1

Cholesterol-lowering drugs may also lower PSA, but stopping cancer risk effect is unknown

According to the study, statins are lowering the PSA levels, but the concern is whether or not this could be hiding or clouding the issues and cancer could be potentially missed in the diagnosis as they are not sure if this is lowering the test numbers or if it is in fact helping in the prevention of prostate cancer growth.   Up and coming genomics testing might be of help here soon in this area.  BD  image

DURHAM, N.C. -- Popular cholesterol-busting drugs -- statins -- appear to lower men's PSA values along with their cholesterol levels, according to researchers in the Duke Prostate Center and the Durham Veterans Affairs Medical Center. But whether the drugs prevent prostate cancer growth or just mask it is not known yet. "Previous studies had shown that men taking statins were less likely to develop advanced forms of prostate cancer but no one had looked at the relationship between the drugs and prostate-specific antigen, or PSA, a biomarker that is correlated with cancer growth and is the most common prostate cancer screening tool," said Stephen Freedland, M.D., a urologist at Duke and senior investigator on the study. "Our study represents a move to understand if and how statins influence prostate biology and whether they are really reducing cancer risk, or simply making PSA a less effective screening tool.

"This is important because we had some men who started with PSA levels that looked to be headed in the direction of a recommended biopsy to look for prostate cancer, but they weren't there quite yet," said Robert Hamilton, M.D., a urologist at the University of Toronto, who served as this study's lead investigator while he was a research fellow at Duke. "In a good proportion of these men, the PSA levels declined sufficiently to a point where physicians might not recommend a biopsy, so it's really important that we understand what's at work here, so we can be sure we're not missing cancers because of deceptively low PSA levels."

Related Reading: 

PCA3 Test May Help Distinguish Aggressive Prostate Cancer

Cholesterol-lowering drugs may also lower PSA, but whether they cut cancer risk is still not known | Cancer Forums and News

Will We Vote Against a Candidate's DNA in 4 years?

This is a very interesting article as we have all read about athletes and looking at their DNA, so instead of medical records in 4 years we might be digging though a candidate’s DNA.  For the snoop and people type of publications this could get real interesting to see an agent pay off a waitress for a coffee cup that someone drank from, only to run it to the local genomics office to get the full details. 

The last comments about CEOs is a bit entertaining as well, will the CEOs of the future need the right DNA to hold those positions?  For that matter DNA might be telling all of us where we might be better placed, but there’s one big competitor here, astrology that might give DNA a run for it’s money.  I mention all of this in jest, but in 4 years I don’t think any of us can offer a real suggestion as to where we will be as one breakthrough today seems to be changing more than one path of history, and we need computers to keep up with it.  If a corporation is not making money would it lie in the fact that the CEO sequences didn’t fit the money gene?  BD  

In the coming era of personal genomics -- when we all can decode our genes cheaply and easily -- political candidates may be pressed to disclose their own DNA, like tax returns or lists of campaign contributors, as voters seek new ways to weigh a leader's medical and mental fitness for public office. The technology is advancing so quickly that the next generation of presidential hopefuls may be judged not just on the content of their character but also on the possibilities revealed in their genes, highlighting the tension between privacy and public life.

While medical records can be locked away, it's not so easy to control access to DNA samples. "It can be picked up from a coffee cup or a hairbrush," says Dr. Annas. "People can take a copy and decode that information and learn things about you that nobody else knows, including you." Only 10 states have laws that make it illegal for DNA to be analyzed without the donor's consent.

"In the future, should we ask CEOs for their genetic profiles? Maybe we should," says Dr. Allen, "if we believe this kind of testing could tell us something that would save shareholders money."

Science Journal - WSJ.com

Resources on the Medical Quack – Added Clinical Trial Update Information

Well I have been busy moving things around again!  Not too bad I think though, just a few changes.  Thanks so much again for everyone who takes time to stop by!

One new item is a widget for Clinical Trial information.  If you happen to be on the site and want a quick look up of the updates, there is widget for this now.  It scrolls so you can do a quick check and link to the full story. 

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And right above this link is the widget for Live OR, so you can do the same and link to the entire post from here. 

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I also moved the translator to the upper right hand side, and when I put the widget on the site I was not sure on whether or not it would be used, but it is!  There are several readers in Germany, a few in Brazil and Spain that use it regularly, so welcome and thanks to my international readers! 

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Doctors' Offices Work to Keep Patients During Economic Downturn amidst the continuing Red Tape and administrative overload

Every blogger, myself included has written about the upcoming shortage of physicians, well this is predicated on better healthcare, but as we are seeing from the downturn in the economy, people are not going to the doctor to take care of their health, it is still a “risk management world” out there, and if some folks get healthier along the way, it is viewed as a plus.  So now physicians have one more battle on their hands besides all the administrative nightmares that go with dealing with insurers, and that is to work with patients with discounts and further encourage them to take care of their health, but how do you do that when the pot is running low?  House payments and rent come first.  image

Then there will be the P4P (pay for performance) issues that crop up next with the insurers evaluating the patient care and why Suzy has not had her mammogram and what have they done to encourage it, but the physicians can only lead patients to the water, they can’t make them drink, so again one more downside of the “risk management world” of healthcare today.  Give it a little more time and the reviews will be in with their local managed care office auditing and scrutinizing what each member is doing, if they have not given any thought as to why this is occurring.  The audit process can be interesting too when the local IPA comes up with questions on deceased patients, who of course no longer need a mammogram or a PSA test and the practice has to inform them that the patient is deceased, and the physicians get drilled about patients who are no longer coming there, but have changed to another physician, and again all a waste of administrative time to have to document all of this for the practice.  Do these things happen frequently, they sure do as the insurers don’t always have their records up to date and it is up to the physician to fill them in.  This once more cuts in to the valuable 10-15 minute time slots for consulting with patients too.  BD 

As Americans are cutting back on health care costs, doctors are working to keep their offices full. According to a survey of 75 physician practices, revenues are down 3.5% this year, compared with a rise of 6% last year, Dow Jones Newswires columnist Victoria Knight reports.

Health Blog : Doctors' Offices Work to Keep Patients During Economic Downturn

The Doctor's Office – Deluged with Red Tape and Paperwork

From the IT side of things, I can’t agree more with all the additional administrative functions that appear in today’s medical practice, as a few years ago when I was writing code and creating a medical records program, much of what I was doing was looking for ways to automate some of this, to free the physicians and medical assistants from all the labor intensive paperwork, like getting rid of the Chinese fire drill to the fax machine and putting internet faxing in place.  We have, of course evolved in technology way beyond that stage, but simple image solutions like that made a world of difference to how the office was able to handle the influx of additional administrative work that rolls down the pipe every day.

You do need technology in a practice today to keep things humming and maximize the amount of time spent with patients, if not, you are chasing the eternal paper trail forever.  Most patients don’t see the back side of the administrative functions and for good reason, as the clinicians are there to focus on your healthcare, only when there is an issue with payers, does this really emerge.  I do remember about 5 years ago telling physicians that who ever has the data, managed and organized is going to win this game and this is precisely what we have today, the payers ruling how healthcare works, risk management.  A few years ago they looked at me in disbelief, but it is what it is, but when you write code, you know exactly where things are headed, because you write the stuff that makes this happen and evaluate and look at the software written by other developers to integrate and evaluation.   

After spending time with practices on updating technology and finding better solutions, you do find out quite a bit about the people you work for, so as a practice, make sure you have a very trusted IT individual who is there to work as a partner.  When bringing in computers and and internet, there were always those who wanted to test the water, so I found software, logs, etc. and spyware issues, and many more items on networks, and again this was before we had some of the updated software available today to restrict and maintain access to proper websites, and nobody ever knew how any of that got on their computer or network, as they never visited those sites.  Your IT partners know more about the practice and everyone who works there than you think, thus again it comes back to working with a real team IT person that can work through some of these situations with you.  As a rule of thumb today, I tell everyone “whatever goes on the internet, stays on the internet”, so think twice about what you do at the office, as your computer is at home.  image

But getting back to the administrative nightmares, they do exist and get uglier every day, just choices alone complicate issues not to mention the snags that come in to play.  This truly makes a very good case too for us to work as patients to think about our own personal health records and bring some information to the table to help our physicians with all the information we need today, and on the other hand the physicians need electronic records to sort out all the information to help and diagnose our conditions in that sacred 10-15 minute visit.  All of us can choose to query the web and take multitudes of extra time if we want, but the smart patients and physicians today are quickly using technology to get the job done, otherwise we are still back standing at the fax machine, and waiting, and waiting and waiting…BD 

Did you feel healed the last time you went to the doctor? My bet is no. If you were lucky, maybe you got 10 minutes with the doctor. In not much more time than you might have spent in a fast food drive-thru, the doctor wrote a prescription, ordered a battery of lab tests and sent you off for a thousand dollars worth of imaging studies. Somewhere along the line too many doctors stopped being healers and became prescribers and technicians.

The modern physician pushes the paper around, convincing the insurance clerks to pay. The sad fact is the documentation of your visit and paperwork for referrals likely take your doctor as much time as seeing you.

Still, I know how much harder it has become to get things done compared with when I started practice a decade ago. I have to fight insurance companies more to get the drugs and treatments I think my patients need. I have to refer patients to bigger groups of specialists, and the quality of their service has gone down.

The Doctor's Office - WSJ.com

Edwards Emerges From Her Husband's Shadow

Being this is breast cancer awareness month, nice feature on Elizabeth Edwards and how she not only is battling breast cancer, but the public display of her marriage, which she has pretty much kept under wrap.  Cancer is tough enough to battle as it is, but add on the other side of what happened in the public eye and that makes for a lot of stress and even more uncertainty when you need your life partner the most and they are not there for you, or let’s say in the way we all hope our partners would be.image

There is a video at the site and it somewhat makes one think about what is really important in life, fame, fortune or the true pursuit of happiness and can they all live together.  BD 

She looks a bit fragile," observes Liz Roberts, an Arlington woman in the audience Monday evening. "Maybe vulnerable," says her friend Debbie Nichols. And yet Elizabeth Edwards is here. Inside the Beltway, in front of the cameras, one week before the Election Day she once dreamed would carry her husband into the giant white house just seven blocks away. The "husband," as she refers to him, is not here. This is Elizabeth's gig, her topic, on her terms. There will be no mention of the scandal. No interviews allowed.

From the beginning, to an astonishing -- almost painful -- degree, Elizabeth Edwards has shared her personal life with us. In her book, blogs and endless campaign interviews, she has spoken with striking candor about her own experiences. The death of a teenage son. Giving birth two years later, at age 48, and again at age 50. A diagnosis of breast cancer one month before John Kerry and running mate John Edwards lost the 2004 presidential race. Remission, a second presidential campaign, and a return of the cancer.

Edwards Emerges From Her Husband's Shadow - washingtonpost.com

A card-swipe for medical tests

New technology in development, a card that you would swipe just as is done with credit cards.  As listed below the card could give instant information relative to PSA testing, Herpes, and markers with personalized medicine.  The results would be within a few minutes instead of days or even weeks as we have with some test today.

The technology is using the same principles use on a PC today with hard drives and MP3 players, so someday we could look at a multi purpose MP3 player/medical test device?   

It also has environmental implications as well to find bacterial in water for a simple example.  The card when finished could hold up to 1900 samples for testing.  Amazing technology in the works, and here I am just hoping to have my medical information on a card I could swipe, and this goes much further than just data!  BD 

University of Utah scientists successfully created a sensitive prototype device that could test for dozens or even hundreds of diseases simultaneously by acting like a credit card-swipe machine to scan a card loaded with microscopic blood, saliva or urine samples.

The prototype works on the same principle – giant magnetoresistance or GMR – that is used to read data on computer hard drives or listen to tunes on portable digital music players.

"Think how fast your PC reads data on a hard drive, and imagine using the same technology to monitor your health," says Marc Porter, a Utah Science, Technology and Research (USTAR) professor of chemistry, chemical engineering and bioengineering.

imageThe prototype card-swipe device consists of a GMR "read head" and sample stick. Right now, the device is about the size of a PC. But Granger says that when it is developed commercially, the GMR sensor device will look like a credit card reader. 

-- Current tests for prostate specific antigen (PSA) – an indicator for possible prostate cancer – only look for "free" PSA but not for other forms. A card-like sample stick with multiple "addresses," each with an antibody that binds to a different kind of PSA, would be able to test a blood sample for multiple forms of PSA and for their relative abundances, and thus be more reliable in predicting prostate cancer, Porter says.
-- "The same approach can be used to screen patients for other cancers or heart disease," Granger says.
-- A rapid, card-reader test for genital or oral herpes could help reduce the number of Caesarean sections. If obstetricians suspect maternal herpes, they sometimes do C-sections to avoid transmission to the newborn, Porter says. A conclusive, rapid test for herpes can tell doctors if a C-section is really necessary.
-- Porter envisions GMR sensors as tools for personalized medicine, in which "you want to establish everybody's baseline with various health markers" – tests for various diseases and disease susceptibilities. Then, people would monitor health changes by periodic re-testing in a doctor's office, pharmacy or perhaps at home.
-- GMR sensors could provide rapid detection of porcine parvovirus, a respiratory infection that kills pigs; feline calicivirus, which does the same to cats; and bacteria that cause Johne's (pronounced yo-knees) disease, a fatal wasting disorder in dairy cows that costs $1.5 billion annually in the United States.

http://www.physorg.com/news144565304.html

The C Diff Cure, an effective (but yucky) procedure

When you read this is sounds pretty dramatic, but the procedure is working.  Family feces donors are needed.  This is another hospital acquired infection that is growing almost as fast as MRSA and one to be aware of.  The process involves a stool transplant and is running about a 95% cure rate, so when faced with the choices of living with it, or giving this a try, I would think the procedure is now seen in an imageentirely different light.

The process involves injecting  the liquid through the tube and into the stomach.  The donor’s material is mixed with water and filtered to take out the organic matter, leaving a dark brown liquid that contained billions of bacteria.  The process does not sound that bad, it’s more or less the ingredients that make this an odd treatment, and it’s not as difficult as finding an organ donor by any means.  BD 

Dr. Johannes Aas was stumped. The patient in his Duluth, Minn., clinic was not responding to antibiotics, and now the stubborn infection in his intestines threatened to kill him. Then Aas found a similar case written up in a 1950s Norwegian medical journal. The cure? Replace all the bacteria in the patient's gut with a tiny dose of someone else's stool.

The cure that Aas discovered that day worked almost instantly, but other doctors scoffed. Well, they are not scoffing anymore. With the proliferation of dangerous superbugs that are resistant to antibiotics, the unusual treatment is gaining respect from researchers across the country.

Often, a dose of a different antibiotic will suppress the infection. But sometimes C. difficile just keeps coming back.
"I was so, so, so sick," said Keri Primbs, 34, of California, who was treated for a C. difficile infection in Duluth in 2006. "I had diarrhea 20 times a day." The infection lasted on and off for a year. She and her husband "nicknamed it the beast." "We just need that little brown bag," said Dr. Timothy Rubin, a gastroenterologist who works with Aas. He meant the stool sample from Jolliffe's husband, which was being processed in the lab. It was mixed with water and filtered to take out the organic matter, leaving a dark brown liquid that contained billions of bacteria.

Aas says he doesn't know exactly why the stool transplant works. He presumes that the infusion of donated flora resets the bacterial balance in the gut and somehow keeps the C. difficile in check. Whatever the mechanism, it works 95 percent of the time.

Related Reading: 

Meet Clostridium Difficile, The Next MRSA Superbug You Need To Worry About

Maggots for MRSA and C Diff - Hospital Acquired Infections

Hospital incidence of one disease soars: study - C Diff

A nasty bug, an effective (but yucky) cure

At Home Bi-Polar Genomics Test

Your DNA will be tested for GRK3 and two of its genetic variations and yes you receive a “spit kit” for your deposit.  The site also states the test is only available for those individuals showing symptoms, so if you are not in that category, the test is not for you.  I would also think that it would be a good idea though to consult with your doctor first and work as a team rather than just placing a mail order for the interpretation. 

Probably more important to find out is if serotonin-based drug treatment would be genetically acceptable for use.  If the economy doesn’t shape up soon, we might all be thinking about a test (grin).  I did a another post and someone asked me about the test, so here it is if thisimage proves to be helpful.  As it states below they suggest the test if one was considering anti-depressants, and it won’t tell you if you will develop bi-polar, that part I guess is still a surprise.  BD 

From the website: 

Psynome™ – tests for two mutations in the GRK3 gene that are associated with bipolar disorder. Patients who have either of these two mutations, are Caucasian, of Northern European ancestry and have a family history of bipolar disorder, are three times more likely to have bipolar disorder. The price for the Psynome test alone is $399. 

Psynome2™ – tests for mutations in the Promoter L allele gene that predicts patient response to serotonin-based drugs, the most commonly prescribed drug therapies today. No other DNA test exists today to identify an individuals positive or negative response to SSRIs. The serotonin transporter gene is associated with response to SSRI antidepressants, as well as, several other traits including vulnerability to stress induced major depression. Patients with one of two genotype mutations that are Caucasian and suffering from depression, are twice as likely to benefit from treatment with an SSRI type of antidepressant. The price for the Psynome2 test alone is $399.

The identification of each new gene, added to the current list of patented genes, will continue to improve the specificity, sensitivity and diagnostic accuracy and lead to a greater understanding of these diseases. Future genetic discoveries and collaborative relationships will allow Psynomics to expand the range of its tests to include other mental disorders.
The company will not test individuals who have no symptoms but want to know their likelihood of developing bipolar disorder.
  • It does not tell you if you will develop bipolar disorder in the future.
  • It does not tell you if your children will develop a mood disorder
    • You Should Consider Testing If:
      • You have had problems with depression, mania or irritability and want to know if you have a genetic predisposition to bipolar disorder and whether you should seek treatment.
      • You are currently being treated for depression or bipolar disorder and you and your doctor want state-of-the-art DNA testing to help confirm your diagnosis and choose the best treatment.
      • You are being treated for depression and your doctor would like to test you for possible bipolar disorder
      • You and your doctor would like to know how you will likely respond to serotonin-based drug treatments.
      • You are being treated, but want a second opinion regarding your diagnosis and treatment.
      • You are being treated with, or are considering treatment with, antidepressants.
      • You would like to learn more about the possible role of genes for mood disorder in your illness and in your family.

      https://psynomics.com/products.php

      I’ll take one used Defibrillator Please…

      A new study is being done on re-using medical devices.  A while back I had a physician make the comment on heart defibrillators not being re-used, but he would know more on that topic than I would.  Will we be someday making a decision on whether or not we want a “new” device or “pre-owned”?  Obviously it depends on what the devices, so I wouldn’t think that a used knee or hip would be any good, but there certainly are other devices if they could be properly sterilized that could be of use.  The companies listed below were some that were to be included in the study to see if some of their devices were in fact re-usable.  BD 

      NEW YORK, NY, Oct 29, 2008 (MARKET WIRE via COMTEX) -- With the high cost of disposing medical waste, hospitals have begun to reduce the amount of biohazardous waste by turning to reusable medical devices and instruments, though they still generated approximately 7,200 tons of waste each day in 2007. A new report from Kalorama Information, "Reusable Medical Devices and Instruments," values this market at $4 billion and estimates significant growth of 12.9% annually through 2012. For a long time the trend was to use low cost disposables for convenience.

    • Aesculap
    • Arthrocare
    • Cardinal Health
    • Conmed
    • Genesee Biomedical
    • Integra Life Sciences
    • Jarit
    • Kapp Surgical
    • Karl Storz
    • Kinamed Inc.
    • Mediflex
    • Medtronic/Xomed
    • Stryker
    • Surgical Specialties
    • Vision Sciences
    • Wallach Surgical Device
    • Long-Term Savings Found in Reuse of Medical Devices - MarketWatch

      Brainsway gets FDA nod for device trial – Another Device for Transcranial Magnetic Stimulation

      image This certainly seems to be the month of the “brain devices”.  Just last week the FDA approved one magnetic device to zap your brain and now we have another company from Israel to begin trials in Israel and 2 other areas.  The device approved for last week is only for severe cases of depression, but this unit looks like it it imageset up to take on a lot more, Bi-Polar and Obesity.  Obesity is a big problem in the world and even more so in the US, perhaps we might be just a few years away from a few zaps to help out.

      (TMS) is what the treatment plan is called, so it would appear we might be hearing this word a lot more in the future.   The Brainsway machine looks a little more heavy duty too than the one from Neurostar. 

      From the website: 

      Deep TMS uses a unique, patented coil design to produce directed electromagnetic fields that can induce imageexcitation or inhibition of neurons deep inside the brain.

      The patient is seated on a chair, with his head resting comfortably on a head support. The patient is fitted with ear plugs to attenuate the sound if the TMS pulses. The H Coil is put onto the patient's head at the location appropriate for motor stimulation of the hand. EMG recording electrodes are connected to the hand muscle, and motor evoked potentials are recorded, for determination of the desired TMS intensity.

      the head at the optimal location for treatment. The treatment is composed of a session of trains of TMS pulses, typically delivered for a period of 10-20 minutes. In accepted treatment protocols, the same treatment is applied on consecutive days over several weeks. The treatment has no significant side effects. The most prominent sensation felt by the patient during treatment is a small vibration of the coil elements over the head.

      With all the new devices coming out recently, perhaps out dependence for medications in some areas could stand to decrease.  All the TMS devices still leave me with visions of “One Flew over the Cuckoo’s Nest” though, but my own thoughts there.  It does make you wonder where we will all be in a few years from now, as you can already order your do it at home Bi-Polar test for $399, so who knows, get your kit, take the results in and get zapped, but by that time you will have your complete genomics sequencing already completed and more than likely be carrying the gene for it anyway (grin).   BD 

      Brainsway gets FDA nod for device trial The company plans to begin a multi-center trial of its deep Transcanial Magnetic  Stimulation device soon. Globes' correspondent26 Oct 08 12:14 Brainsway Ltd. (TASE:BRIN) has obtained US Food and Drug Administration (FDA) approval for its Investigational Device Exemptions (IDE) application for a clinical trial of its deep Transcanial Magnetic Stimulation device for the treatment of depression. The company plans to obtain institutional review board (IRB) approval from medical centers in the US, Europe, and Israel for the multi-center trial, which it expects to begin soon. Brainsway has developed a method for treating neurological and cognitive disorders by magnetic stimulation of the brain, with differing disorders treated by focusing on specific sites in the brain.

      Related Reading:

      NIH Suspends Emory Grant Amid Questions Over Pharma Payments

      FDA Clears Neurostar® TMS Therapy For The Treatment Of Depression

      Home Bipolar Disorder Test Causes Stirs

      Brainsway gets FDA nod for device trial

      The BrainScope Company

      A short while back I had said algorithms were one of the two hottest terms today in healthcare and this product is no exception as algorithms using thousands of patient data records are used to define brain dysfunction.image

      The software contains a database of brainwave recordings, which serves as the basis for developing profiles involving deviation from normal values against which a patient’s electrical brain activity can be compared.  The zoon product is still awaiting approval from the FDA, but in short it will be a portable device to help medical professionals determine if and where brain damage has occurred.  The device could have use with sports as far as being able to determine brain damage immediately from the playing field up on injury. 

      The technology used is somewhat old and  controversial, qEEG (quantitative electroencephalogram). There are currently 4 university hospitals working with the device and the armed forces also have express an interest in the product as well, so now it’s up to the FDA. Michael Singer was recently hired from Revolution as the CEO.  BD

      The BrainScope Company, Inc. is developing a new generation of hand-held, simple-to-use, non-invasive instruments that, unlike existing technologies, can aid medical professionals and other trained users in quickly, accurately and objectively assessing brain function at the initial point of care, allowing patients suffering from brain dysfunctions to be promptly guided to appropriate treatment.

      Everest Biomedical successfully developed two products with Bx elements that have already been proven on the market – the AUDIOscreener® infant brain monitor, which was sold to VIASYS Healthcare (now part of Cardinal Health), and SNAP II®, an intra-operative surgical monitor that was acquired by Stryker Corporation.

      BrainScope’s first product ZOOM, now pending FDA clearance, is an advanced 8-channel brain electrical activity data collection system with post-hoc statistical analysis. The ZOOM system uses accepted methods of data selection, analysis, and feature extraction, including discriminant functions for probability of abnormality and other valuable information.

      BrainScope’s first product ZOOM, now pending FDA clearance, is an advanced 8-channel brain electrical activity data collection system with post-hoc statistical analysis. The ZOOM system uses accepted methods of data selection, analysis, and feature extraction, including discriminant functions for probability of abnormality and other valuable information.

      The BrainScope Company, Inc. // Biography

      CLARO Receives FDA-Clearance for Treatment of Acne

      You even get a choice of colors, Blue, Hot Pint or Black.  The product uses Intense Pulsed Light delivers a series of light pulses in 6 seconds that safely penetrate the skin to eliminate the bacteria that cause acne, an acne zapper.  It is small enough to carry in your purse if needed.  It will cost $275.00 and you will need a prescription from your physician as well.  The timing element of 6 seconds seems to make it the fastest treatment I have seen on the market, and there are many today. 

      COSTA MESA, Calif., Oct 29, 2008 /PRNewswire via COMTEX/ -- Handheld Device is First to Use IPL to Clear Acne Blemishes CLRS  imageTechnology today announced the CLARO acne-clearing device received marketing clearance by the US Food & Drug Administration (FDA) for treatment of mild to moderate inflammatory acne. CLARO, the first hand-held device to use Intense Pulsed Light (IPL) for treatment of acne, will be available by prescription January 2009 from medical professionals, including dermatologists, family practitioners and pediatricians. "CLARO represents a new option for women and men of all ages who suffer from inflammatory acne," said Richard Oberreiter, CEO and Founder, CLRS Technology. "Unlike other at-home devices on the market for acne treatment, CLARO uses clinically proven Intense Pulsed Light (IPL) technology, combining heat and light to clear acne fast.

      image

      This sure beats the solution these folks found (grin).  BD 

      Got Acne Problems - Go Buy a Condom

      CLARO Receives FDA-Clearance for Treatment of Acne - MarketWatch

      Google Health Online Services – Connections Beyond Medications – Personal Health Records

      The other day I posted about some of the vendors Google Health connects with and today I’ll add a few more. These online services go beyond prescriptions and labs, and some are in fact, other subscription forms of personal health records. As mentioned before, as we now have Health 2.0 in action, the software is being written differently from the ground up. Unlike the medical records systems that were created for doctors years ago, the connections and software of today is located on the web and not necessarily on the desktop, although some programs have a desktop applications that works with the one on the web, pretty much just to make the systems easier to open and imageuse.

      There is no way everybody would use everyone of the vendors on the list, as it would more than likely make you crazy, so again it comes back around to us being the “informed patient” when it comes to our healthcare. If you need vaccines, then you might want to look up the vendor that specializes in that area. LiveStrong, another vendor offers information and tools about general healthcare and occasionally even picks up something from the Medical Quack as well.

      imageAnother interesting vendor is Trialx.org. Their up and coming service will allow you t connect with investigators from your Google Health Records and find available trial programs for a quick and easy match, along with setting up a full line of communication between you and the investigators, all done easily from Google Health and the service is also available in HealthVault as well.

      If you are having problems getting your records in to Google Health, there is also a service called Unival that will for a fee help you get everything you need in your records.

      If you have not set up a PHR yet, now might the be the time to give this some thought. The patient has options to share any records with any physician, hospital, etc. they desire so it is up to you who will be able to see and utilize which record you enable.

      Why sit around manually and enter all the information yourself when credible data can be done via a data transfer and formatted for you. The old records of the past didn’t give us this option, but now with Health 2.0, that option is there and working. There is a permanent link on this site to get started at any time. BD

      These websites offer personal health services. When you link a website to your profile, you may authorize that website to read your Google Health profile or to automatically send and update information in your profile (such as medical records or prescription histories). You decide which permissions to grant when you sign up with each website. Google doesn't own or endorse these websites and isn't responsible for their content or performance. The Google Health privacy policy does not pertain to other web sites, so check each service's privacy policy and share information only with sites you trust.

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      Related Reading:

      Google Health Vendors you can connect with and import records – Personal Health Records

      Drugmakers Seek to Cut Red Tape to Speed Cancer Trials

      Getting Organized With Online Medical Records – Personal Health Records

      Google Health: Explore health services