11/23/2008 - 11/30/2008 ~ Medical Quack

ZietGeist – a movie that discusses the future

11/28/2008 04:02:00 PM My Commentaries, Other Items of Interest

This is a bit off the wall, and when you have about 2 hours it’s worth giving a watch. I didn’t agree with everything stated here and anyone watching may not either, but you might come away with some knowledge about technology and some thoughts about the future of where the world is going. There are some political messages here and some pretty strong, but some of the technology they discuss here and some past history events might prove interesting to view and hear about.

The movie gives the history of money and how it got started in the US. About half way through after the history, things shift gears and some interesting technologies are presented and some history, healthcare very much included.

After watching this you may want to read up on this recent article called “The End”, which is a very good accounting of some of how the entire Wall Street Collapse began and how it evolved to the final days. Michael Lewis, who wrote Liar’s Poker starts with his beginnings and how his book made him and brought down C.E.O. John Gutfreund and the last lunch the 2 had together and their discussions.

“The era that defined Wall Street is finally, officially over. Michael Lewis, who chronicled its excess in Liar’s Poker, returns to his old haunt to figure out what went wrong.”

http://www.zeitgeistmovie.com/

Technorati Tags: ZeitGeist,Movie,Technology,politics

Thanks to the Happy Hospitalist for posting this on his blog for the rest of us to read.

Prescriptions risk score used to deny health insurance

11/28/2008 02:35:00 PM Medically Related, My Commentaries, Pharma/FDA News

Lawmakers are going to have a difficult time with this one as they are not technically up to date enough as a whole to comprehend how all of this works in my estimation. with understanding the algorithms of finance and the economy, Wall Street showed us that. Sad, but it is true and this is not the only area of privacy where nobody is minding the shop. If you don’t understand it or are not aware of it’s existence, how do you regulate and protect citizens? I’ve been asking this question for a long time as in some instances I can see some of this coming before it gets here, but for heaven sake, let’s worry about the PHRs out there, when risk management is much more of an invasion and is going on now at present.

What is funny is that I get marketing information wanting my participation from some of those exact same marketing groups (not EMR vendors) that feel they have all the answers on electronic medical records and their use, well maybe they do have part of it going here as it would appear to me that it has to benefit their interest, so in that area I’m not interested.

Insurance companies also exchange a ton of information on all of us through the MIB as well, the medical insurance bureau. Now all these organizations of course will offer you a copy of what they have on file, but is this doing anything to protect privacy, I think not. So now we have 2 sources to really nail down a ton of information, drugs and the MIB.

I find it extremely bizarre that we want better and affordable healthcare for all, but yet risk management stands up right in the way of progress here to head off any big human risk that might apply for coverage. The related reading below has additional information on this topic and several items on the MIB. Again, our Congress makes the laws and rules, and yet in so many areas they are not technically up to date enough and so risk management goes on behind the scenes to basically sell and market any part of our information with few or very little restrictions. The business is so profitable for Blue Cross that they have taken millions of dollars to build a Venture Capital company whereby they can invest money in other additional risk management ventures to keep the wheels rolling.

The companies get assessed fines, they pay them and just keep on going as there’s probably a few trillion sitting in the reserve funds if you were to put it all in one pot and yet folks wanting health care can’t get what they need and are scrutinized for eligibility and claim payment, when they need it the most. Somewhat sad when all those trillions of dollars in reserve just sit there, untouchable. BD

BlueCross BlueShield Create New Venture Capital Organization

Did you know there's a market for your prescription data? Insurance companies are buying prescription data collected from companies like Milliman Intelliscript and Ingenix to help them make insurance coverage determinations.

Right now lawmakers are trying to figure out how to oversee a health-industry shift to computerized records and insurers have started testing systems that tap into prescription drug information.

Milliman Intelliscript, part of the Milliman Company, collects data from Pharmacy Benefit Managers (PBMs) that are not covered by the Health Insurance Portability and Accountability Act of 1996. Then insurance companies pay a small fee to obtain the data, which they use to deny or approve claim requests.

http://www.myfoxorlando.com/myfox/pages/News/Detail?contentId=7948495&version=2&locale=EN-US&layoutCode=TSTY&pageId=3.5.1

Related Reading:

Nearly 1 in 6 Online Health Insurance Shoppers Are Uninsurable

Allstate testing “brain fitness” software on older drivers

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

Discrimination and Health Insurance: Big Brother in the Workplace and Beyond

Sorry, folks, but it’s true: You are for sale

Nearly 1 in 6 Online Health Insurance Shoppers Are Uninsurable

What is the MIB - Medical Insurance Bureau - and how does it affect qualifying for insurance?

Governor blasts Blue Cross over confidentiality : California

Health Insurers Show 14 Percent Increase in Use of MIB Data

Blue Cross/Blue Shield of Massachusetts reports $57.6 million profit for the 3rd quarter

Technorati Tags: Health Insurance,Venture Capital,Blue Cross,Blue Shield,Healthcare,Reserve Funds,Profits,Hospitals,Prescriptions,Privacy,Congress

German court rules big boobs are not a medical problem

11/28/2008 12:50:00 PM Medically Related, Other Items of Interest

This is a procedure women here in the US undergo all the time for a reduction, but in Germany the court decided no, but again we may not have all the details here as well, but she had been told my doctors to have them reduced as she was suffering from orthopedic and physical problems. What may have been a monkey wrench though was a prior case with the opposite situation brought to court of needing an enlargement, and I might guess that case was pushing the limits.

Also, the insurance company stated her problem was due to being overweight, but with no picture here it’s hard to tell on this one whether or not she was obese or really needing the reduction, but still with being obese and if she was still having issues it makes you wonder. BD

A COURT has ruled that insurance companies do not need to cover the cost of breast reduction surgery. The court ruled ruled that having a large bust is not a medical problem and as such insurers will only have to pay to correct breasts which are deformed. The case was brought by a 38-year-old woman who suffered orthopedic and physical problems due to the weight of her boobs, bild.com reports. She had been advised by doctors to have breast reduction surgery.

German court rules big boobs are not a medical problem | Herald Sun

Technorati Tags: breast reduction,Germany,obese,insurance,healthcare

Doctor tries to blame hand wash for drunk-driving arrest – the hands didn’t have it

11/28/2008 10:47:00 AM Medically Related, Other Items of Interest

Nobody wants a DUI for being under the influence, and especially during the holiday season coming up, but this physician went the limit as far as trying to explain how all that alcohol just happened to get in his system! He said it was the handwash! Good try but no dice here.

There have been stories of people ingesting handwash and getting intoxicated in prison facilities, etc. and some of the product has had to be removed, but good grief, do you also maybe value your stomach? Obliviously this physician had not been ingesting the handwash, but rather felt the over use it it was trying to do him in, perhaps if he feels this is a real issue maybe some good old soap and water might help, anyway, somewhat amusing article on the lengths some folks might go to when exceeding their own limitations. BD

A New Zealand doctor has been convicted of drink-driving, despite blaming an alcohol handwash he used at work. Ian Denholm, 53, had pleaded not guilty to the charge, saying the surgical handwash put him over the legal limit. The orthopedic surgeon has been fined $275 (£180) and had his license suspended for six months by a Wellington court.

The doctor claimed his eczema provided an extraordinary ability to absorb alcohol in the hand wash gel he used to scrub up after operations.

The judge agreed to postpone his license suspension until 23 January as Denholm is the on-call surgeon over the Christmas holiday season.

BBC NEWS | Asia-Pacific | Handwash blamed for drink-driving

Technorati Tags: DUI,Handwash,physician,alcohol

Safety and Effectiveness of Using CyberKnife on Prostate Cancer

11/28/2008 10:06:00 AM Medically Related, Technology

When it comes to cancer today there are many different options to look at and discuss with your physician as to which option, depending on your diagnosis and condition would be the best plan, but as this article states, we really won’t know how effective some of the new technology really is until enough time passes to gather such. Under related reading I listed a few other posts that relate to other prostate cancer treatments that are available or being used perhaps in a clinical trial surrounding.

In looking at the CyberKnife page, there are several additional add on options that can be included, as well as the software required to analyze and create images and reports. It is also used for treatment of other types of cancers. As the article states, the Medicare reimbursement for a physician is $1200 for each patient that undergoes the treatment process and it involves 4 to 5 visits with radiation intensified in the cancerous areas, hopefully leaving otherwise healthy tissue and organs untouched. The treatment time certainly is something that any patient would think about compared to some other alternative treatment plans just simply due to the lesser amount of time needed.

Again, one of the biggest concerns here is the lack of time an information, are patients being cured and time is about the only method that will allow to gain the statistical information needed for studies to be compiled. On the other side of the coin, there’s the questions of whether or not the treatment is being oversold, with advertising on radio, billboards, etc. as mentioned here with billboards flooding the highways in Florida as an example. Just like many procedures out today, there’s always the question of insurance and Medicare coverage, some will cover, others will not as it does run a bit more than other treatments. Just recently in the news the offices at CMS were rallying to try and do some cost management to be able to make decisions on what they would or would not cover, in essence removing this decision process from the advice of the physician treating the patient and only covering the cheapest option, which in turn would be disastrous at it would serve the purpose of putting such technology out of the reach of many patients diagnosed with cancer and needed treatments as such.

Court Blocks White House Push on Medicare Expenses

Similar types of treatment therapy are also being used in the treatment of breast cancer such as the MammoSite , and again the same question arises, is it a cure and the need for more time to pass to gather the needed data. On the other hand not to approve and get some of the new technology out there, would a shame as well. So much of this is still a science in essence and until there is enough time to substantiate the clinical documentation, it will somewhat still be an opinion or guessing game to a degree. In the meantime, who knows what might appear on the horizon tomorrow? BD

When Georgetown University Hospital bought a new high-tech system in 2001 to treat patients with radiation, doctors at first used the computerized, robotic device only for brain and spinal tumors that would be difficult if not impossible to fight any other way. But Georgetown, along with Virginia Hospital Center and others around the country, is now aggressively marketing the $4 million machine, known as the CyberKnife, for early prostate cancer, one of the most common cancers. That trend has sparked an intense debate about whether it represents an important advancement or the latest example of an expensive and potentially profitable new technology proliferating too soon.

The CyberKnife enables men to complete treatment in just four or five sessions by much more accurately delivering about quadruple the usual dose of radiation each time. Doctors inject four tiny gold cylinders into the prostate to create a precise target. The patient lies on his back for each one-hour session as a robotic arm swivels around to shoot dozens of beams from multiple angles.

Safety and Effectiveness of Using CyberKnife on Prostate Cancer Patients Debated

New Online Calculator for Prostate Cancer Patients and Doctors Developed

Despite Doubts, Cancer Therapy Draws Patients - HIFU Prostate Cancer Procedure

Surgery By Numbers - Glowing Cancer Cells

FDA Approves HIFU Clinical Trial For Recurrent Prostate Cancer

New Generation Of Radiation Therapy More Precise - TomoTherapy for Treatment of Prostate Cancer

Doctor and robot a life-saving team - Orange County, CA

Bloodless Prostate Cancer Surgery Performed

Court Blocks White House Push on Medicare Expenses

Technorati Tags: Cancer,Prostate Cancer,Online Tools,PSA,Biopsy,Calculator,Oncology,CyberKnife,healthcare

A new source of generic Wellbutrin available soon

11/28/2008 09:50:00 AM Medically Related, Pharma/FDA News

Teva Pharma has a generic version, but earlier this year there were some consumer complaints, now the FDA has cleared another manufacturer to produce a generic version, Watson Pharmaceuticals. This is for the 150 mg dose. No word yet as to the availability from the article. BD

CORONA, Calif., Nov. 26 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength. Bupropion Hydrochloride Extended-Release Tablets is the generic equivalent to GlaxoSmithKline's Wellbutrin XL(R) product, which is indicated for the treatment of major depressive disorder. Watson intends to launch the product immediately.

Watson Pharmaceuticals, Inc. | Investor Relations | News Release

Technorati Tags: Wellbutrin,generic drugs,Watson Pharma,drugs,GlaxoSmithKline,FDA

With bloggers Is anything Off The Record?

11/28/2008 09:21:00 AM My Commentaries, Other Items of Interest

Good post here about bloggers, you never know where we lurk, but more importantly, what are they going to blog about? Well for the most part good bloggers use common sense, but as in anything out there, there’s always exception to the rule. Personally from this picture, I think photographers represent more of a threat as the old saying goes a picture is worth 1000 words.

There was no way this government official knew the bartender was a blogger, but then again, she lost her job too, so what was accomplished here, a whole of nothing in my opinion. One thing today we are all still getting used to is that the minute we step outside our front door, there’s the potential of someone watching, and that business is getting busier a some of the monetary gains from some of this when published is growing too, so guess the old rule of thumb is to be sure and project the image you want seen as soon as you step outside your front door.

Also, from the blogger’s perspective an old saying of mine is “what goes on the internet, stays on the internet”, so if you blog about something, make sure it’s what you want to be read and seen out there too as it is a reflection of yourself too, as it just takes a couple seconds for someone to “cache” or save the page and republish, even if you remove the original, if someone wants it bad enough, it will happen, especially if there’s an ax to grind or money to be made. BD

There’s a lot of buzz here in the Belgian blogosphere and mainstream media about an incident involving a New York-based blogger, who was fired from her job as a bartender after publishing a post on the bar visit of a Belgian politician. I’m generally hesitant to share ‘local’ stories here because I want to keep it relevant. In this particular case, I think it is.

Worst part, she wrote, was the fact that one of the politician’s advisors admitted to her that the meetings they were there for on taxpayer’s money were in fact cancelled because the UN was meeting in Geneva (which is about 330 miles from Brussels). He reportedly told her they had decided to come to NY anyway despite being aware of the cancellation because the political situation here was ‘calm’ and that he’d ‘never visited the city anyway’.

http://www.techcrunch.com/2008/11/28/when-everyone-is-a-blogger-nothing-you-say-is-off-the-record/

Technorati Tags: blogging,commentary,blogs,common sense

High Definition Surgery from Sony with four new products

11/27/2008 01:06:00 PM Medically Related, Technology

New products from cameras, printers and monitors can now make surgery room high definition from Sony. There’s a short video at the site with a couple examples and the inside of the body certainly looks a lot different. Monmouth Medical Center in New Jersey was the site of a case study. The system has been used to credential new surgeons. The pathology connection allows the surgeon to have a pathologist present.

If a pathologist is not available, televideo can do the connection remotely for one to participate over the web. Many surgeons already take pictures and this now can be expanded easily to video. Won’t be long before everything we do is on video for that matter.

One HD camera is mounted high so that the entire surgery room can be seen and it can be controlled either within the surgery room or remotely. The televideo capabilities also bring in the option of an immediate 2nd opinion. All at the case study agreed that specimen management and information exchange is certainly an expedited process with the system.

Universal Connectivity and Compatibiity
Multiple video input formats enable compatibility to all surgical systems manufacturers: HD-SDI, DVI-D, SDI, YPbPr, RGB, S-Video, or composite Connects to DICOM or non-DICOM networks (interfaces directly with DICOM Worklist server) Captures still and video images in either high definition or standard definition Compatible with any printer and includes built-in drivers for Sony digital color printers

Superb Usability
Three open USB ports for ancillary devices. Portable media for both SD and HD for immediate playback; SD: Burn CD/DVDs or save to USB storage device HD: Burn Blu-ray discs or save to USB storage device HD: Save to CompactFlash for instant playback on Sony PlayStation 3 or PC equipped with CF card reader and Windows® media player

The HD capture system also converts dicom images etc. to Power Point Presentations. We have HD at home, so why not in the surgery room where it really counts. BD

Heading up its new range is the company’s first ever medical HD camera, the MPW-10MD HD, which offers unparalleled image quality for high-precision surgical applications. It is the first model of its kind to use full HD 1/2 CMOS sensors rather than the industry standard 1/3 CCD models.

The company has also unveiled the smallest A4 dye sublimation printer on the market with its UP-DR80MD model, designed specifically for medical applications and particularly suited to endoscopy.

Also launched was the UP-DF750 FilmStation, a versatile multi-format imager for radiography and mammography applications and the LMD-3250MD, a full 32” medical grade LCD monitor designed for endoscopic, surgical reference and educational applications.

http://www.hesmagazine.com/story.asp?sectionCode=196&storyCode=2048799

Technorati Tags: Sony,healthcare,HD,High Definition monitor,camera,sensors,operating room,medical imaging

ProstateCradle.com Launches external Prostate Therapy Device by Enviromax

11/27/2008 12:17:00 PM Medically Related, Other Items of Interest

This is a real product and the price is $49.00 and simple to use, just sit on it. The film is good for a few chuckles as well. The product also boasts some additional benefits, but you can use the links to explore for more information.

There are products somewhat similar for women with breast massage and therapy products. The page from Forbes stated if I did a preview I could possibly get a product for a full review – pass, but thought I would mention this for any other bloggers who read the post. There are all kinds of medical products that come out all the time and I try to do my best here on keeping everyone advised. BD

Most men are expected to have some kind of prostate issue, and the longer they live, the more they are at risk. But that's just part of the story. Doctors recommend prostate massage as preventative and therapeutic. According to Enviromax and prostatecradle.com, prostate massage is one of the oldest and most beneficial therapies, and has been prescribed by medical doctors for centuries.

From the website:

The Prostate Cradle is easy to use: just sit on it!
gentle pressure for a stimulating massage! The
Cradle reaches underneath the pelvic arch to
stimulate the prostate & perineum areas. It works
'hands free' using a normal chair while doing
normal things like reading or using a computer.
The Cradle is discreet, no one can tell when you
are using it, and it even works over clothing.

ProstateCradle.com Launches the First "External Prostate Massager" by Enviromax, a Sensational... - Forbes.com

Hat Tip:

Medlaunches

Technorati Tags: Prostate,massage,healthcare,therapy

Taiwan Firms Companies with hospitals in China – New Paradigms?

11/27/2008 08:59:00 AM Medically Related, Other Items of Interest

Part of the incentive here is that the average cost per day in a hospital in Taiwan is $90, compared to $110 in China, so a bit of room for negotiation and pricing strategies. Also what was extremely different here is the fact that the new hospitals are being created by companies known for their manufactured products, consumer electronics and plastics, in other words not long term healthcare companies by comparison. Does this mean that basically anyone could come out of a manufacturing background and create a healthy hospital system, it sounds like there’s some of this going on at present. The physicians from Taiwan too are anxious to work in the new state of the art hospitals too.

The Chinese government sure seems to be open to granting licenses as well as it is pretty well known that the state run hospitals have not been ranked well at all by comparison with other countries, almost near the bottom of the listings. Due to geographic location, Taiwan is able to fly doctors to China if needed. In short, the US is not the only country investing in healthcare in China, but again the most notable fact here is that the companies creating hospitals are not long established healthcare companies but rather manufacturing companies. Is there something they are bringing to the table that has perhaps been missed or overlooked by others? I always say there is something to be learned from everyone out there and this might be a good example here on using some new paradigms rather than the old died in the wool methodologies we have all relied on.

We have some of this going on here in the US, as an example with Sony creating a high definition operating room, but it’s only a portion of the entire solution and not the entire hospital structure. If nothing else it certainly points to the fact that technology is certainly coming out ahead in molding and moving healthcare in a new direction, the technology that we all need and will depend on, no matter where it’s roots are. BD

For years, foreign health-care providers have moved cautiously in China, mainly offering Western-style medicine to expatriates and rich Chinese. But now some Taiwan companies are taking a radically different tack: selling low-cost quality health care to China's masses.

The move is risky. China's health-care market is fragmented and largely insulated from criticism because the state runs most of it. But the companies have an interesting edge: All are Taiwan manufacturing giants that have been running low-cost factories in China for years.

Taiwan Firms Head for China To Make Money on Hospitals - WSJ.com

High Definition Surgery from Sony with four new products

Technorati Tags: China,hospitals,Sony,Taiwan,manufacturing,technology,investments

Oncology Services Europe enters opens clinical trials in India

11/26/2008 11:42:00 AM Pharma/FDA News, Technology

Other countries outside the US are also expressing and formulating their clinical trial business in India. Of late there have been a multitude of these reportings, it doesn’t appear India will be lacking in the R and D trial business any time soon. BD

The operation will be run by the newly formed Oncology Services India (OSI) and gives the company access to a large number of therapy-naive patients.

OSE hopes the move will establish it as a new international “Oncology Specialist” within the global CRO industry.

http://www.outsourcing-pharma.com/Clinical-Development/Oncology-CRO-enters-India

Technorati Tags: India,Clinical Trials,Oncology

Teva Pharmaceutical raided in European Union antitrust probe

11/26/2008 11:26:00 AM Medically Related, Pharma/FDA News

The entire focus is to see whether or not patent laws have been violated and if less expensive generics were in any way stalled from getting to the market place. It all boils down to intellectual-property rights and patient disputes. Interesting that Teva is settling lawsuits and will be supplying medications before the patents expire. It appears if you pay enough in a court case or fine, the door opens to begin selling the generic versions. Allegra has been one such drug in the news of late with a settlement of this type. BD

Teva Pharmaceutical Industries Ltd., the world's biggest generic-drug maker, France's Les Laboratoires Servier and Slovenia's Krka Group d.d. have been raided by European Union regulators as part of an antitrust investigation. The raids of the three drugmakers on Monday came as the European Commission is scheduled to release a report this Friday in Brussels on possible antitrust abuses in the pharmaceutical industry. The commission began that probe in January after raiding offices of GlaxoSmithKline Plc, AstraZeneca Plc, Sanofi- Aventis SA and several competitors. The EU's review of the pharmaceutical industry is focused on whether research-based companies misuse patent rules and lawsuit settlements to keep less-expensive generics off the market.

Spokesmen for Glaxo, Europe's largest drugmaker, Novartis AG, Sanofi, Merck KGaA, Novo Nordisk A/S, Boehringer Ingelheim, and AstraZeneca said they weren't aware of this week's raids.

Teva raided in EU antitrust probe | Business News | Jerusalem Post

Hat Tip: Pharmagossip

Technorati Tags: Pharma,Teva,Europe,generic drugs,anti trust,lawsuits,intellectual property

Siemens Introduces New Standard Of Care For Breast Ultrasound

11/26/2008 11:08:00 AM Medically Related, Pharma/FDA News, Technology

The software, Virtual Touch Tissue Quantification, is the first and only application to provide a numerical value related to tissue stiffness at a precise anatomical location. It is not yet available or approved by the FDA for use in the US, but is pending a 501 (k) approval. The unit has been used in a hospital in the UK now for a year. The evaluation of the stiffness of tissue adds one more dimension to the process, so more algorithms available for a better and more accurate diagnosis. BD

From the website:

The ACUSON S2000 ABVS is ideal for virtually any clinical environment — from dedicated breast centers to radiology departments, women’s health clinics to private practices.

The ACUSON S2000 ABVS features:

A dedicated breast scanner that provides full-field volume imaging for streamlined workflow
Views of the anatomical coronal plane and others, not available with conventional ultrasound
ABVS Workplace supports intuitive volume image analysis, manipulation, and comprehensive BI-RADS® reporting capabilities

Siemens Healthcare (http://www.siemens.com/healthcare) highlights the ACUSON S2000(TM) Automated Breast Volume Scanner (ABVS)(1),the world's first multi-use, automated volume breast ultrasound system, at the 94th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) from November 30 to December 5 at McCormick Place (Booth #922, East Building/Lakeside Center, Hall D) in Chicago. Siemens also demonstrates how Tissue Strain Analytics(2), a new dimension of diagnostic information, and intelligent knowledge-based workflow solutions, empower physicians to leverage ever-increasing imaging information density to achieve greater diagnostic confidence and decreased study time.

Siemens Introduces New Standard Of Care For Breast Ultrasound

Technorati Tags: Siemens,Breast Ultrasound,Radiology,healthcare,breast scan,FDA

2 Biotech Companies Face Potential Delisting on Nasdaq

11/26/2008 11:02:00 AM Medically Related, Pharma/FDA News

Current economic conditions are taking their toll on the biotech industry. Both companies are involved in research and development for cancer drugs and treatments. BD

Exact Sciences Corp., a Marlborough company trying to use genomics to develop cancer-screening technology, said today that its common stock will be transferred from the Nasdaq Global Market to the Nasdaq Capital Market, effective Friday.

The company said that the Nasdaq Listing Qualifications Panel is analyzing the company's plans for demonstrating compliance with the stock exchange's listing requirements and that "the panel may still determine to delist the company at any point in time."

http://www.boston.com/business/ticker/2008/11/exact_sciences_11.html

Avalon Pharmaceuticals, Inc. (Nasdaq:AVRX), today announced that on November 20, 2008 it received a Deficiency Notice from The NASDAQ Stock Market, LLC notifying the Company that it is not in compliance with NASDAQ Marketplace Rule 4450(a)(3) because the Company's stockholders' equity, as reported in the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2008, did not meet the minimum of $10 million required for continued listing on The NASDAQ Global Market. This notification has no immediate effect on the NASDAQ listing or trading of the Company's common stock.

http://www.medicalnewstoday.com/articles/130973.php

Technorati Tags: Nasdaq,genomics,cancer drugs

Doro Launches HandleEasy 330 & 326i GSM Wireless Handsets in the U.S.

11/26/2008 08:03:00 AM Other Items of Interest, Technology, Windows Mobile

This looks like a real winner here, big screen, big keys! The phones will be available at Centennial Wireless stores in the US, but they are not all over the country, pretty much in the Midwest and Southeast. Store locations here. The phone is already available in several other countries outside the US.

It also can do text messaging too, so maybe some more baby boomers and seniors may enter in the world of text messaging! It also has an ear hook to help those with hearing aids to hear more. This is a simplified phone for those who may not want or need the whistles and bells of a more complicated phone. BD

Doro, the IDEA award-winning phone design company from Sweden, announces the availability in the U.S. of mobile phones designed by experts in ergonomics and in communications technology to meet the needs of consumers seeking design simplicity and functionality in mobile handsets. Two Doro HandleEasy models available in the U.S., the HandleEasy 330gsm and the HandleEasy 326i gsm, are GSM-compatible, include large easy-to-view display screens and keypads, features that baby boomers and active seniors use most, and none of the complicated features that often go unused.

Doro Launches HandleEasy 330 & 326i GSM Handsets in the U.S. - Cell Phone Digest

Technorati Tags: cellphone,wireless,Doro,seniors,baby boomers

FDA Delays Johnson and Johnson Antibiotic Over Clinical Trial Data

11/26/2008 06:48:00 AM Other Items of Interest, Pharma/FDA News

This one is very interesting so say the least, and it sounds like a software issue of sorts, not enough audit tables or was the data corrupted? Being a geek those are the questions that come to my mind when I hear the word “integrity” , but it may not be the issue at all. Who does the audits since it appears to be contracted? How data rich are they with business intelligence as relates to trials? Clinical trial data is a pretty complex and complicated reporting system these days. BD

The agency sent Johnson & Johnson and its partner, Basilea, a so-called complete response letter that mentions a bunch of problems, or what Basilea calls “specific deficiencies of study conduct.” In other words, the FDA wants additional audits of clinical trial sites for Ceftobiprole, a broad-based spectrum antibiotic to treat the deadly MRSA superbug.

What went wrong? There was a failure to ensure proper monitoring of the studies. And so the FDA wants info on clinical quality assurance programs and also asked for a new audit plan that addresses failures in monitoring by unnamed contract research organizations. In a statement, Basilea says the FDA is unable to review the clinical data until “issues of data integrity have been resolved.”

http://www.pharmalot.com/2008/11/fda-delays-jj-antibiotic-over-clinical-trial-data/

WebHealthCentre Telemedicine– Free Consults and Radiology interpretations from India

11/26/2008 02:12:00 AM Medically Related, Other Items of Interest, Technology

The portal is by patients in 16 countries, including India, the U.S., Canada, and the U.K. The services are free. There is advertising on the site but not more than any normal website contains these days.

Their services are for both patients and physicians and you need to register to begin to use any services other than the normal health care education items.

Telemedicine and teleradiology are both free, but there’s one big long page of all the disclaimers. So, I looked at the page and yes you can set up a health record account and upload images for a free interpretation. That item surprised me.

You are given a consultation number and don’t even need an email address, although they suggest one and state that they will respond to email questions as well, but it might take a bit longer to get back with you.

Again, the free radiology interpretations were a bit of a surprise to me to see this offered free to a patient, as this was the profile I created and don’t know exactly how the physician and student services are provided. I would guess the imaging would also be free for a physician too. All you do is upload the image.

They may also add electronic medical records (EMR) facilities through the site and are planning to offer to set up similar healthcare portals for pharmaceutical and healthcare companies worldwide.

The site is averaging over 3 million hits a month. BD

From the website:

About Teleradiology Solutions Ltd.

Teleradiology Solutions was founded in 2002 by two Yale trained physicians, Dr. Arjun Kalyanpur and Dr. Sunita Maheshwari. It was initially set up to provide hospitals in the United States with night shift radiology solutions. However it grew rapidly and now provides teleradiology to hospitals in Singapore and India with other countries on the anvil.
Teleradiology Solutions (US) is accredited by the US Joint Commission of Accreditation of Healthcare Organizations (JCAHO). It is also the first organization outside Singapore to be accredited by the Ministry of Health, Singapore.
The company provides teleradiology services to hospitals around the globe, which includes interpretation of all non-invasive imaging studies, namely CT, MRI, ultrasound, nuclear medicine studies and digitized Xrays. The company provides subspecialty consultations in cardiovascular and oncologic imaging to hospitals in India as well, and has joint research partnerships with major technology vendors such as GE, to explore new techniques in 3D imaging analysis.

WebHealthCentre.com brings to you Online Consultation facilities from some of the region’s leading medical institutions and consultants. Here you can send in your detailed medical queries pertaining to various aspects of your health and these questions will be answered by the Consultants in the various specialities. This service is provided FREE of charge and can be utilized by Doctors and patients alike.

There are at present over 20 major medical specialities for which Consultation is available at WebHealthCentre.com. Each speciality has a specially prepared detailed form encouraging you to provide as many details as possible. This is to ensure a more accurate reply.
Newer specialities, institutions and consultants from different regions are constantly being added.

You may also send in your investigation reports like X-ray films or E.C.G. strips as attachments to admin@webhealthcenter.com mentioning your consultation number.

Indian IT services company, Tata Consultancy Services (TCS), plans to commercialize its WebHealthCentre, an online portal for medical consultations, healthcare information, and telemedicine. The WebHealthCentre site (http://www.webhealthcentre.com/) was set up by TCS in 2000, as part of fulfilling its corporate social responsibility. The site was started to offer patients in rural areas access to specialist doctors. "We realized that there was a gap for this kind of service even abroad, as we got more queries from abroad than from India," said Debashis Ghosh, vice president and head of TCS' life sciences and healthcare practice, in a telephone interview on Tuesday.

Tata Plans to Commercialize Healthcare Portal (PC World) by PC World: Yahoo! Tech

Technorati Tags: telemedicine,teleradiology,India,Healthcare portal

FDA May Need Major Restructuring – Catch up with Technology

11/26/2008 01:11:00 AM Medically Related, Pharma/FDA News

Some issues are a result of still being paper driven as timely reports and real time information are not available, but they are not the only government agency in this scenario, only one of the most critical though. Also, some members of Congress don’t use computers either and felt uncomfortable about talking about technology, so that adds to the confusion and a few more stuck in the past with understanding where technology needs to be today and what is required with technology to regulate. It was reported that some key employees were still writing out reports in longhand too.

A short time back I added some suggestions using technology and copied below. The FDA does need some technology help to cover all the bases they have today as there is no way in the world they can physically have enough people to cover the world; it’s not like it was a couple years ago by any means with the number of imported food and drug items increased, and they are feeling the same pinch as many others, except in their case it’s top priority work for all of us and time for some heavy duty Business Intelligence. BD

FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us," said William K. Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health but also to the industries it regulates."

Although the FDA has started opening offices overseas to try to better police safety standards at the source, experts say much more needs to be done. For starters, the agency needs to sharply boost inspections abroad, develop strict new regulatory standards, and update and integrate its computer systems, which are woefully antiquated and disjointed, Nielsen and others said.

"It's still largely a paper-driven agency," Nielsen said. "The agency has great information pigeonholed all over the place, but it cannot be applied in real time, which is what you need today."

One of my ideas from a prior post:

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

I don’t think in view of the current events, there was a lot of choice here for the FDA, and we do need to know that the quality of both our food and pharmaceutical products is good.

One thing in particular that springs to mind for me here here is perhaps some use of business intelligence for monitoring. This is not a cure all for the entire process, but technology can aid and offer some nice assistance here. A reporting function would need to be set up to automatically report back to a central agency on criteria established for each drug or food product. At the receiving end, anything out of tolerance would be immediately sent to an alert. Now granted, this should be done locally from every plant, but when you can’t physically have agents in place at every factory all the time, this could offer some real relief and help.

With today’s speed of data transmissions, a server farm could be set up to monitor this type of activity and before an over seas factory began to export to the US, this would be a prerequisite to be established. Each lot before packaged would send the chemical content back to the central gathering agency and report in, with both the US agency and the local factory itself having the information at hand.

Again, this comes back to adding some new software and algorithms to the process, but computers could provide this information in a couple of seconds. Audit trails would also be there to allow for checking back on submissions. A bank of sophisticated server farms could do the work. This would also tend to build product credibility as well if everyone knows up front that the chemical content was being reported before the end packaging occurs. Again, not to replace an actual physical inspection all together, but, it would also stand to make those inspections much more information rich and valuable and create safe consumable products.

We do so much today by remote transmissions with information reporting, why not put in in place and use it where it is vital. This could also be done globally too, with each country receiving reports on products they import from other countries. It would sure beat some of the guesswork we see out there today, not to mention illnesses and death from products that are tainted or contaminated. With the global economy changing every day, it makes sense to know what we are getting and it is impossible to physically monitor all the systems without using some modern day technology.

A secondary thought here too is to ensure that all products carry a label showing the city, country, etc. of where the product was manufactured so we don’t incur the long time delays in figuring out which lot went where, no more blind shipping documents as they exist today. Wonder why this process has not been considered yet? BD

Ailing FDA May Need Major Restructuring - washingtonpost.com

Related Reading:

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

Business Intelligence for the FDA on the way

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

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

Sneaky Attempt to Impose Medicaid Regulation

Bureaucracy Has Delayed Plans For Three FDA Offices In China, HHS Secretary Leavitt Says

Mayo & Johns Hopkins CEOs Want Buffer Between Congress & Medicare

FDA Budget Swells as Administration Bows to Congress

Technorati Tags: Personalized Medicine,Healthcare,Leavitt,CMS,FDA,technology,medical records,integration,Congress,Pharma

GangaGen cultures $5.4M to treat bacterial infections

11/25/2008 09:30:00 PM Medically Related, Pharma/FDA News

More investing to develop drugs to help in the battle with staph and MRSA infections. All R and D is located in in India. BD

Biotech firm GangaGen, based in Palo Alto, Calif., brought in $5.4 million in fifth-round funding from ATEL Ventures, Otsuka Pharmaceuticals and ICF Ltd. to develop treatments for bacterial infections. The company specializes in antibiotic-resistant strains of bacteria, like Staphylococcus, in the medical, veterinary and agricultural areas. It currently has a preventative prophylactic and a topical treatment for wounds and burns in the works.

From the website:

GangaGen's unique business strategy is to maximize efficiency through cost-effective R & D operations in Bangalore, India, pursuing the treatment of commercially significant infections that require the most straightforward and least expensive clinical trials, some with strategic partners.Most importantly, GangaGen has developed proprietary technology for the production of phage products that address the perceived concerns about phage therapy, by killing the bacterial pathogen without bursting open the bacterial host, namely, Lysis-Deficient Phages.

GangaGen cultures $5.4M to treat bacterial infections » VentureBeat

Senators Seek Study on Best Practices – Health IT

11/25/2008 09:23:00 PM Medically Related, Other Items of Interest

Desmond Tutu was doing the same thing this week for developing countries with his call to action. BD

” Partridge, president and chief executive of Vital Wave Consulting (Palo Alto, Calif.), says interoperability so far has failed in the U.S. because multitudes of competing interests have not fully embraced such principles. “The developing world can learn a lot from [the mistakes of] the developed world,” Partridge says.”

Senators Kent Conrad (D-ND) and Sheldon Whitehouse (D-RI) have requested the Government Accountability Office study best practices used by hospitals, states and other nations to reduce health care costs and improve quality. GAO is an investigatory agency of Congress. Conrad is chair of the Senate Budget Committee. Sheldon, a strong advocate of federal action to accelerate health information technology adoption, is a committee member.

The senators ask that the GAO study include an identification of best practices and the extent to which they can be adopted on a wide scale. "In preparation for congressional action on health reform, it would be helpful to understand how these best practices, whether from the states, integrated delivery systems or other countries, can be applied to the system as a whole," the letter states.

Senators Seek Study on Best Practices

Personalized medicine will rely on IT – It’s all about Software

11/25/2008 08:54:00 PM Medically Related, Microsoft/Windows News, Technology

Let’s put it another way, it can’t exist without IT. Again it all comes back to running algorithms to obtain desired results. As I have mentioned before, Algorithms is one of the hottest words right now in healthcare as we all make decisions from queried results.

A while back I had the opportunity to interview Dr. Patrice Milos, Chief Science Office for Helicos, who is one of the manufacturers of the machines that complete the sequencing of our DNA. Up front she and I were absolutely both in agreement – it’s all about software. She was also very kind in her comments as well as she stated she was somewhat excited with talking with a tech person that understood algorithms too! She lectures all over the country to bring the same message to universities as well with pharmacogenomics. BD

“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.”

We still have a long way to go in healthcare all the way around and with the current state of the economy, mergers, buyouts, etc are going on every day and week with software companies.

One other item it mentions is from the clinical side of the puzzle. Business models in healthcare do parallel those of the retail business in many ways. In retail, everything takes place at the point of sale, or better known as the POS. Healthcare has a similar model in that everything takes place at the point of care, and I guess you could call it the POS for healthcare or POC.

I have been having this discussion of late with the availability of alerts with clinical trials being integrated into EMR/EHR systems and personalized medicine is no different. The information needs to be made available on screen and easy for the physician to work with, otherwise it gets buried. So how many screens and alerts can be worked with, well that is a good question and preferences need to be allowed for each clinician to set up what works best for him or her.

I’ll go one step further this this and once again mention the Common User Interface, which by structure is dynamic and has the ability to add new elements in a format that is simple and easy for the physicians and staff to work with. You can read more in related reading about the software interface which is free to download from Code Plex and code donated from Microsoft and soon to be available in Linux and the dynamics contain some nice Silverlight visuals.

Microsoft’s Growing Push into Life Sciences

So back on subject here, having the genetic information on certain genes present can make a big difference as to whether or not the patient could withstand taking Warfarin for a simple example, and we still don’t know yet if Medicare will pay for the test, but one simple example on how personalized medicine can make a difference based on DNA information. The face of DNA sequencing and genomics is quickly changing too with the price coming down and a vendor in northern California promising “wholesale” sequencing with the interpretations done elsewhere. The link below has some additional information at the physician and clinical level on personalized medicine. BD

Genetic Counseling Foundation - References and information for Genomics in Healthcare

The complexity of the personalized medicine ecosystem makes the use of information technology critical, according to Kenneth Buetow, director of the National Cancer Institute’s Center of Biomedical Informatics and Information Technology.
However, IT has been slow to develop in the biomedical enterprise, Buetow writes in a recent report, adding that systems are rarely connected among the laboratories of one institution, much less different institutions.
Buetow’s comments are in one of the papers in the second report on personalized medicine from the Department of Health and Human Services. The report also summarizes the HHS summit on the topic in October.

In another papers, investment experts write that “HIT vendors have a unique opportunity to provide the dynamic, point-of-care decision support necessary to support the broad adoption of personalized medicine.”

http://www.govhealthit.com/online/news/350693-1.html

Related Reading:

Single Cell Gene Sequencing from Helicos – How it works

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

How Hot is Genomics and the Sequencing Machines?

Helicos Ships Sequencer to Stanford University

Expression Analysis to Award GWAS Resequencing, Analysis Services on Helicos Platform

EHRs need Standard Templates – So Let’s Look at the Common User Interface Project, a lot of the work is already in progress and partially completed

Health care has managed to avoid the information-technology revolution, but it won't for much longer

How electronic records reach your doctor – Integrated through the Hospitals

EHR Adoption Remains Off in the Distance – Getting way to complicated

Microsoft Technology Centers – Software Solutions with Assistance and Guidance

Common User Interface – Update and walk through video

Cerner Incorporates Genomics Into Electronic Medical Records

Scripps, Navigenics, Affymetrix and Microsoft team on groundbreaking health study – Personalized Medicine

Technorati Tags: genomics,personalized medicine,DNA,healthcare,sequencing,Microsoft,Helicos,technology,Health IT,Biotech,medical records,EMR,EHR,pharmacogenomics

Are electronic and personal health records inevitable? – Sure they are but we need education and mentors to make it work!

11/25/2008 01:26:00 PM Medically Related, Microsoft/Windows News, My Commentaries, Other Items of Interest, Technology

ZDNet just wrote about Dr. Kolodner and his recent report which is good, but we need more than reports. I have been doing a whole lot here reporting on reports! Can we move forward as I think we have won the battle that PHRs are worth their weight here and get the show moving?

You know I try and do my best here to motivate and have my records set up and tell others, but gosh I could sure use some help?

I would really like to hear about others and their experiences too instead of someone else just posting about another report they read, wouldn’t you? We know they are valuable so let’s get some interesting stuff out here besides more reports, it’s getting very boring. I try to provide a mix here of both “Oh Gosh” posts and informative information too, so the PHRs could move from the informative area into the “Oh Gosh” category easily! Let’s get some mentors going here.

I check my web logs and I see folks from Microsoft, Google, NIH, the VA, Homeland Security, the US House, US Senate, Department of Homeland Security, Department of Defense, MIT, Berkeley, Stanford, NASA, many hospitals, physicians, students, many universities, journalists, bloggers,etc. hanging out here, so some input would really be great, as it’s getting old with me talking about mine and my 84 year old mother’s online records. Anyone from any walk of life with their input can serve to be a mentor for others.

Second of all, let’s get the education process in the works.

The Wall Street Journal and Reuters were both kind enough to republish my small rant on how we are so lacking in educating our citizens here and I thank them for the attention hopefully this will bring about. What good is it to put beneficial programs out there related to healthcare without some education in the process, and this is needed from all areas from the CEOs down to the janitors, after all PHRs are for everyone, not just something to continuously talk about and continue to quote reports over and over.

Any CEOs out there have one yet? Any physicians use one yet? Any students? I would really like to have some mentors and see a true endorsement of educating our citizens, something we need to target and make time for. Great that Medicare has the pilot program starting in January in Arizona and Utah for PHRs, but where’s the support, I have not read about any yet? Is this just something we through out there without any education or any ability to supply them with any mentors of those already using a PHR? What gives here?

PHRs can help reduce medical errors, if both patients and physicians understand them. They are “cool” so as any type of administrator you don’t need to worry or feel that you are “uncool” by creating and using one and I hope that paradigm is not lurking out there, but I wouldn’t be against it.

Google Health and Microsoft HealthVault are free so all it costs is your time. The related reading contains many of my prior posts on PHRs for more information to find out who’s incorporating the software vendors, who’s integrating and just some real benefits. With Google Health and HealthVault, if you decide not to keep it, then delete it, nothing lost and everyone might learn something in the process and stop writing about reports about PHRs, it’s getting very boring, so perhaps time for a little learning and action. BD

Kolodner is the national coordinator, health information technology, at the U.S. Department of Health and Human Services, and his background makes him a good man to have in that job.

That’s because much of his hands-on experience involves VistA, the VA’s public record health system. He seems to understand the benefits of open source and open standards.

Kolodner has written that this year represents a “tipping point” for the adoption of Electronic Health Records (EHRs) by doctors and hospitals and Personal Health Records (PHRs) by individuals.

http://healthcare.zdnet.com/?p=1542

Related Reading: (from prior posts and there are a lot here to read up on and see who’s integrating and promoting their use too)