Rite-Aid and OptumHealth (Subsidiary of UnitedHealthcare) Offering Face to Face Virtual Clinic Consults with Optum Doctors and Nurses Inside Stores in Michigan–Cost $45.00

The service is provided via American Well, which has been around for quite a while and their efforts were first used in connection with Blue Cross in Hawaii a couple years ago.  When using the service you get to see an OptumHealth (UnitedHealth care) doctor or nurse for your consultation.  There’s a disclaimer on the Rite-Aid page that states they are “independent providers”.  The nurses and doctors will also be able to refill prescriptions and give out educational information, along with of course grabbing that data and adding it to a data base somewhere in the data bases maintained by the company.  It’s not all a bad thing for care, but as we know prescription data is sold on the market like crazy so you get this at any pharmacy any more as a consumer.  I don’t know what value it holds for Rite-Aid but Walgreens said their data selling business is worth just under $800 million, lot of money.  Prescription costs are not included in the visit and are separate. 

The website says during the promotion period with getting started you get a nurse consult for free and the doctor charge is $45 for a 10 minute visit, so when you log on, clock’s running so be prepared as you can pay more if the visit takes more time. 

Now Clinic

You will need to submit your own claims as that part is not connected but I can guess it kicks out the summary you need to submit your claims and have your credit card ready to pay or an ATM card.  BD

“Services provided via NowClinic online care are not submitted by NowClinic or the provider to your health coverage plan, Medicare, or any state Medicaid program for reimbursement or any other third-party payor. When you use NowClinic online care, you are responsible for all fees for services provided.^”

CAMP HILL, Pa., Sep 15, 2011 (BUSINESS WIRE) -- --Rite Aid and OptumHealth First to Provide "Virtual" Clinics in a Retail Pharmacy Setting

Rite Aid and OptumHealth are bringing the latest in quality, convenient online health care to Rite Aid customers in the greater Detroit area with the introduction of NowClinic(SM) Online Care services, now available inside select Rite Aid pharmacies. NowClinic offers Rite Aid customers real-time access to convenient medical care, information and resources from doctors and OptumHealth nurses. Rite Aid and OptumHealth are the first to provide a virtual clinic in a retail pharmacy setting.

Through private, face-to-face consultations using the Internet, Rite Aid customers can see and speak directly to doctors who are able to discuss symptoms, provide guidance, diagnose and prescribe certain medications when appropriate. Customers can also interact with OptumHealth nurses, who are able to address a range of health care needs such as basic health care education, information on common acute issues and assistance in identifying appropriate provider options for care. A customer record is automatically captured at the end of each interaction and is available for immediate sharing with a customer's primary care provider, maintaining continuity of care.

Customers can also access NowClinic Online Care 24/7 by visiting www.myNowClinic.com/RiteAid , which is especially convenient when customers are not able to visit a doctor's office or for when offices or their local Rite Aid are not open. Currently, conversations with nurses are complementary and a 10-minute consultation with a doctor is $45.

http://www.marketwatch.com/story/rite-aid-and-optumhealth-introduce-nowclinicsm-online-care-services-in-detroit-2011-09-15

Technorati Tags: Rite-Aid,OptumHealth,American Well,video conference,consultation,virtual clinic,nurses,doctors,patients,providers,HealthIT,UnitedHealthcare

Dr Oz and the FDA Differ on Apple Juice Arsenic Content–Show Ratings Did Not Disappoint

Whatever!  Has anyone died from this yet?  I don’t think so and again the news said it buried Anderson Cooper today in ratings.  I like his show and he’s very good at entertaining and bringing good news to light and also I might venture to say that ratings are very much in here to keep the show up at the top.  He’s done a little bit of everything including talking to the dead:)  Last week he gave one of our Los Angeles Newscasters a stress test so he must never rest.  The FDA does describe the difference between natural arsenic and that which is poison and says it is safe, stay tuned as I’m sure there will be more on this one.  BD 

LA-ABC News Anchor Gets a Stress Test from Dr. Oz–And As the Show Moves to Channel 7

Apple Juice Arsenic

Apple Juice

WEDNESDAY – SEPTEMBER 14, 2011  Dr. Oz Investigative report on arsenic in apple juice reveals high levels in the juice you drink. Aging too fast on the inside. The 6 super foods to slow aging and prevent disease. Marjorie Johnson puts Dr. Oz's super foods to the test.

http://calgary.ctv.ca/servlet/an/local/CTVNews/20110914/fda-apple-juice-oz-110914/20110914/?hub=CalgaryHome

Technorati Tags: Dr Oz,belly fat,nutrition,waist measurement,healthcare,11 weeks,dietary supplements,fitness carbs,ABC News,Los Angeles,apple juice

Pfizer Sales Department To Employ Software as a Service Contract for More Analytics Use to Up Production–Gonna Learn Math

Who is not using some kind of analytics today.  I was tweeting earlier that I had 4 press releases today talking about their second to none, outstanding, cost effective and cost effective solutions.  They all sound the same to me anymore, and maybe that’s because a few years back I used to write that kind of stuff, so all in nature and what they do are very similar.  Pharma reps will now be able to be equipped with that stats that they need to drive home how many patients are suffering from the conditions that the drug they are selling will fix or treat.  I might have to change the name of this blog soon to correspond with the news that comes out to the Analytical Quack:)

Boy I really do have to say that so many press releases anymore are such “cookie cutters” and those 5 or 6 templates used really make the round today.  The company with the software slates themselves as the leading provider of “sales enablement solutions”…wait a minute you mean you can sell unless you have software that can “enable” you <grin>.  I also spent 25 years in sales with Fortune 500 companies so a little bit of my sarcasm here as I remember well how the big corporate machines work very well, one area down in revenue, it gets a focus, you sell deals and benefits (used to be pens and lunches) and somehow in a coupe months that area of the company is back on line.  Pfizer has been tablet friendly with their reps for years and has a ton of resources and services already used by their employees to include SharePoint for all and so now they have one more tool to “enable” sales.  BD

Callidus Software Inc. (NASDAQ: CALD), the leader in Sales Performance Management (SPM), announced today that Pfizer Inc, the world's largest research-based biopharmaceutical company, has selected the iCentera Sales Enablement SaaS platform to drive the effectiveness of its sales team in the U.S., including internal sales, contract sales, and channel partners. The agreement was signed in the third quarter of 2011.

"At Pfizer, we need to effectively drive a targeted, relevant value proposition across a large portfolio of products," said Jeffrey LiPira, Director, Team Leader Sales Operations, Pfizer. "With the iCentera Sales Enablement solution, we can deliver targeted product information in real-time across our broad-based, distributed sales network and increase our sales force productivity through more knowledgeable sales people."

http://r.einnews.com/dH7ks+

Technorati Tags: Callidus Software,Pfizer,sales,software,costs,iCentera,marketing,stats

American Academy of Pediatrics Steps in to Correct False Statements Made During GOP Debate that Stated HPV Vaccine Causes Mental Retardation

Well let’s not put any politicians in charge of healthcare issues is what I say.  Whether or not the vaccine is deemed safe is another issue if one wants to dispute the Academy and there are all kinds of discussions and opinions, but it does not cause mental retardation.  BD 

The American Academy of Pediatrics would like to correct false statements made in the Republican presidential campaign that HPV vaccine is dangerous and can cause mental retardation. There is absolutely no scientific validity to this statement. Since the vaccine has been introduced, more than 35 million doses have been administered, and it has an excellent safety record.

The American Academy of Pediatrics, the Centers for Disease Control and Prevention, and the American Academy of Family Physicians all recommend that girls receive HPV vaccine around age 11 or 12. That's because this is the age at which the vaccine produces the best immune response in the body, and because it's important to protect girls well before the onset of sexual activity. In the U.S., about 6 million people, including teens, become infected with HPV each year, and 4,000 women die from cervical cancer. This is a life-saving vaccine that can protect girls from cervical cancer.

http://www.npr.org/blogs/health/2011/09/13/140445104/pediatricians-fact-check-bachmanns-bashing-of-hpv-vaccine

Technorati Tags: politics,GOP,healthcare,vaccines,HPV,cervical cancer

Cochlear Ear Recalls Latest Range of Implants Due to Unexplained Failures

This is kind of sad with this recall as many who wear them depend on the units.  In addition the Cochlear technology is also being used to test for balance disorders with new implant procedures at the University of Washington. 

Ear Implant Device Using Technology from Cochlear Implants Being Tested for Balance Disorder–First Patient Receives Implant

Hopefully this will pass over soon and those who have already been implanted with the device don’t have to worry about the recall as it’s for those who have not been implanted yet.  Last year another company in California also had a recall of implanted hear devices. 

HiRes 90K Cochlear Ear Implant Recalled By Advanced Bionics To Address Safety Concerns With FDA

There is one other company I am aware of, Esteem who received FDA approval last year for their implanted product and so far no recalls there but the approval from the FDA just came in March of 2010. BD

MELBOURNE—Cochlear Ltd., the world's biggest maker of bionic ears, on Monday recalled its latest range of hearing implants after a recent unexplained increase in failures.

Cochlear shares plunged as much as 27% after Chief Executive Chris Roberts said the company has stopped manufacture of the Nucleus CI500 range, which in the 2011 fiscal year made up 70% of the company's sales of implant units.

Analysts said the recall could lead to prolonged market share gains for Cochlear's competitors such as the Austria-based Med-El. Cochlear has about 65% of the global hearing implant market.

"Reliability is very important," Mr. Roberts told analysts on a conference call. "If there's some things happening that we don't understand, we're far, far better to stop and understand it...rather than just battle ahead and hope it all works out."

http://online.wsj.com/article/SB10001424053111904265504576565540894094816.html

Technorati Tags: Cochlear implant,Advanced Bionics,recall,FDA,medical devices,hearing,healthcare,safety

FTC Charges mHealth Apps With False Advertising–No Scientific Evidence for Curing Acne So There’s Not An App for That

This is good as consumers “need to know” and if you read here enough you can hear me rant about all the mHealth devices that only do “one thing” and to have value and make it easier for consumers, having software that can do more than one thing is important.  There are many good apps out there today as well and knowing the difference just simply due to the times we live in today with some really good breakthrough technologies makes is difficult at times.  We live in world where everyone is marketing every inch of a product or software do we do get overwhelmed and a while back I talked about this fact, it is all around us as well as some flawed data lurking around the web too. 

Why Is Almost Everyone In Healthcare Marketing Their “Ass” Off

The FDA of course is working on their plans to verify and ensure that both professional and some consumer products do what they say and of course comply with all HIPAA and other standards.  I think all of the apps should at least register with the FDA for class one and then the agency can take a look and determine which ones need their expertise for approval and at least this way they have a data base of all that is out there as apps change too with adding new features.  With adding new features, a product that perhaps didn’t need approval before may in fact graduate t that category for a simple example.  This way the FDA can use some real business intelligence to have a handle on all that is out there since their job is to protect and this would allow for better collaboration too with the FTC and the bonus part here is the fact that if apps have to register (and don’t make this a cost item) we will have less of a glut of mHealth software and better consumer protection.  

FDA Mobile Medical Applications NPRM From the FDA–Register All With Categories and Create New Classification for “Clone Apps”

Groups like Continua do their best to ensure standards are met and basically if an app and company were part of the group, all could be submitted in a data base to the FDA to save time and effort with registering too.  So if you have acne, these apps are not the cure for you.  BD 

Marketers who advertised that their smartphone applications could treat acne have agreed to stop making baseless claims in order to settle FTC charges. The mobile applications, commonly referred to as "apps," were sold in Apple's iTunes Store and Google's Android Marketplace. The settlements in two separate cases would bar the marketers from making certain health-related claims without scientific evidence.

"Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there's no app for that," said FTC Chairman, Jon Leibowitz.

The cases involving mobile apps "AcneApp" and "Acne Pwner" are the first the FTC has brought targeting health claims in the mobile application marketplace.

The settlements would bar the marketers from making acne-treatment claims about their mobile apps and other medical devices, as well as the safety, performance, benefits, or efficacy claims about any device, without competent and reliable scientific evidence. The two marketers of AcneApp would also be barred from misrepresenting research, tests, or studies.

Finally, the settlement orders would require Koby Brown and Gregory W. Pearson, doing business as DermApps, to pay $14,294, and Andrew N. Finkle, doing business as Acne Pwner, to pay $1,700.

http://www.fiercehealthit.com/press-releases/acne-cure-mobile-app-marketers-will-drop-baseless-claims-under-ftc-settleme

Technorati Tags: FDA,medical devices,mobile medical apps,advisory board,software,MRC,compliance,wireless,heatlhcare,Heatlh IT,FTC,acne

Sermo/Fierce Pharma Survey of Oncologists Named Amgen and Novartis As Being The Top Contributing Drug Companies

This is another in the series of contributions of surveys and polls to provide actual MD comments and results on which drugs companies they feel are the biggest contributors to cancer with the best outcomes.  Amgen and Novartis are the top and there were others as well.  The actual report goes into more detail and you can read the entire report here.  Roche was right in there as well as #3.  BD   

In this new free report from Sermo, oncologists share which companies they believe are the top contributors to their field and what drugs they believe yield the best outcomes for their patients.
A total of 101 oncologists participated in the survey, a majority of which spend their time in clinical practice, treating between 50 and 150 patients per week.

http://clients.sermo.com/Article?art=0009&rs=fpct0009wsx&utm_source=fiercepharmacontent&utm_medium=website&utm_campaign=sermosurvey&utm_content=ctws_ssurvey_pharma_0009

Technorati Tags: FierceMarkets,Sermo,partnership,doctors,regulatory information,patients,cancer,surveys,healthcare,social networks,reimbursement

Is Provenge the Drug That Even Dendreon Is Having Issues Affording–Laying Off 500

This is the latest chapter with the biotech company which has had a long running soap opera to say the least.  In addition the COO will be leaving.  It was just last month the CEO dumped a bunch of stock before announcing they were not going to be even close to goal.  I guess the Medicare ruling that they will still pay for the $93k treatment still stands or will other treatments, such as the new J and J drug move up in the ranks, which is less expensive but still costs money.   I had a reader write to me about Zytiga and said he had insurance but it was still going to cost him $25,000 for his treatment, again with insurance coverage of some sort. 

Dendreon CEO Dumped $1M Stock Before Admitting They Will Not Meet Their Projections for the Year–Layoffs?

The FDA has just approved the opening of another facility in Atlanta, so will it open?  I’m sure that approval process was long in the works before August arrived with the gloom news about the drug.  In addition Sermo and Fierce Pharma also ran a survey to get the word straight from the doctors about how they felt about prescribing the medication for prostate cancer patients and reimbursement issues mattered. 

When Will MDs Prescribe Life Extending Drugs Such as Provenge–Reimbursement And Delivery Matters

So what remains of Provenge moving in the mainstay with immunotherapy drugs I think remains to be seen.  There are other companies using the same immunotherapy processes in biotech to create similar types of drugs, and the cost associated with some of those are yet to be seen, but one thing after all of this that we know now, the drugs need to be affordable and covered by insurance.  In the meantime, the country still faces shortages for the workhorse chemotherapy drugs across the US that “are” affordable.  BD 

(Reuters) - Dendreon Corp said on Thursday it would cut 500 jobs as it seeks to trim expenses in light of diminished sales expectations for its high-priced Provenge prostate cancer vaccine.

The total employee-related cost of the restructuring is expected to be about $21 million, the company said, citing a need to align staffing "with the shift in the (Provenge) launch trajectory and meet the company's manufacturing requirements."

Investors appeared to be pleased by the moves, sending Dendreon shares up more than 4 percent in extended trading.

"Their SG&A (Sales, General and Administrative) cuts are more than expected and will mean $120 million in SG&A savings," said RBC Capital Markets analyst Michael Yee.

http://www.reuters.com/article/2011/09/08/us-dendreon-plan-idUSTRE7876WD20110908?feedType=RSS&feedName=healthNews&utm_source=twitterfeed&utm_medium=twitter&utm_campaign=Feed%3A+reuters%2FhealthNews+%28News+%2F+US+%2F+Health+News%29

Technorati Tags: Dendreon,Provenge,prostate cancer,software,Intellivenge,biotech,FDA,technology,algorithms,active cellular immunitherapy,software as a service

FDA Has A New Training Program for Medical Device Reviewers

This is good thing and it’s the same process that should and does take place when creating medical records, seeing and understanding both sides of the story.  We also know that the FDA desperately needs engineers just like the rest of businesses in the US as well due to the fact that many more devices have software attached either directly or wireless use.   BD

FDA and Medical Devices-Who Doesn’t Get This, They Are Looking for Engineers Just Like Technology Companies Are Doing- Get Some Congressional Digital Literacy in Place

Press Release:

SILVER SPRING, Md., Sept. 6, 2011 /PRNewswire via COMTEX/ -- Training a key step to improving device review program, strategic priorities

The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH).

The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH's Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, will launch this month and is intended to include all new device reviewers.

The program includes up to 18 months of training, aimed at complementing the skills and knowledge that new reviewers bring to CDRH from fields such as biomedical engineering and health care. Reviewers in the program will complete online training modules, instructor-led courses, and obtain practical experience in the medical device review process. Courses include medical devices, food and drug law and regulatory requirements, the CDRH review process, device design, and the impact of human factors.

"We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews," said CDRH director Jeffrey Shuren, M.D. "This investment will improve the quality of submission review and make the process more consistent and predictable."

CDRH is also developing a pilot Experiential Learning Program for premarket reviewers. The program will include visits to academic institutions, manufacturers, research organizations, and health care facilities and is intended to give reviewers a better understanding of how medical devices are designed, manufactured and used. The program will also help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care.

"Providing our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for medical devices," Shuren said.

The Experiential Learning Program is in the design stage and scheduled to begin as a pilot program in 2012.

Enhancing staff training is one of the 25 action items listed in the FDA's Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process. The 510(k) is the most common pathway to market for medical devices.

For more information:

CDRH Plan of Action for 510(k) and Science http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

http://www.marketwatch.com/story/fda-announces-new-staff-training-for-medical-device-reviewers-2011-09-06

Technorati Tags: FDA,medical devices,healthcare,Health IT,software,training,510k,science,safety,technology

Abbott Labs to Discontinue Distributing FreeStyle Navigator Glucose Monitor in the US

The FDA just approved the Freestyle easier to use monitor in June of 2010 and received the European CE Mark in May of 2011.  In December of 2009 there were strip recalls for the old version of the Freestyle, however other Abbott models had a lot more strips recalled in December of 2010. 

Abbott Diabetes Care Recalls Tons of Glucose Test Strips–The US Has the FDA Recall Blues-Solution Has Been Touted Here for a Year-It’s Time for a Fix–Readers Have Voted

Supply interruptions was the reason given for the discontinuing in the US; however in Europe they will continue to sell and market, so not enough money here in the US is the first question I ask and glad we have enough other glucose monitors available for diabetics.  I just hope glucose monitors don’t take the same path as some of the drugs we can’t get today and hope this is an isolated instance.  Abbott still has many other Freestyle monitors they sell and market besides this model, but this one with wireless looked to be pretty advanced.  BD   

Abbott Laboratories (NYSE:ABT) announced that it permanently discontinued its FreeStyle Navigator glucose monitor due to an inconsistent supply chain that has amounted to several disruptions in product availability for U.S. patients.

"We know FreeStyle Navigator System customers in the U.S. have lived with some uncertainty and frustration," the company wrote in its official statement. "We are grateful for the commitment patients and providers have devoted to the FreeStyle Navigator System over the years, and we are sorry that we have been unable to consistently meet their needs."

"The discontinuation of the FreeStyle Navigator System in the U.S. is not for safety reasons," Abbott wrote. "The System is safe and effective and continues to be available to patients in seven other markets outside the U.S."

http://www.massdevice.com/news/diabetes-abbott-takes-freestyle-glucose-monitor-us-market

Technorati Tags: Abbot Labs,recalls,FDA,medical devices,drugs,pharma,technology,Twitter,Microsoft,MicrosoftTags,cell phones,Freestyle

UnitedHealth, YMCA Expand Diabetes Prevention Program with P4P for Walgreens

The process uses UnitedHealth claims data and other demographic information to flag people at risk of developing diabetes and invite them to a free, 16-session exercise and nutrition class at a local YMCA.  Those who already have diabetes receive a 45 minute assessment unless anything has changed.  This goes back to the original announcement of the program.  As it was originally quoted, the YMCA would get around $300 for someone who completed the YMCA program and the Walgreens pharmacists get some form of pay for performance. 

UnitedHealthCare To Use Data Mining Algorithms On Claim Data To Look For Those At “Risk” of Developing Diabetes – Walgreens and the YMCA Benefit With Pay for Performance Dollars to Promote and Supply The Tools

In March of this year the program was expanded to Atlanta. 

United Healthcare Expanding Diabetes Prevention & Predictive Algorithm Program With Walgreens And Pay for Performance Incentives In Atlanta

Again the use of analytics comes into play here as well and Walgreens not too long ago said their data selling business was worth just under $800 million.  People may get healthier with participation and data will more than likely be sold to make money off of selling the patient data at the same time.  It all seems to work hand in hand anymore.  BD 

DALLAS – UnitedHealthcare, area YMCAs and local pharmacies have announced they will partner to launch the “NOT ME” diabetes prevention program of the Diabetes Prevention and Control Alliance (DPCA), an employer- and community-based initiative aimed at diabetes prevention.

Part of the National Diabetes Prevention Program led by the Centers for Disease Control and Prevention, the program is a 16-session lifestyle intervention conducted in a group setting through local YMCAs intended to help people with prediabetes and others at risk, prevent the onset of type 2 diabetes through healthier eating, increased physical activity and other lifestyle changes.

According to UnitedHealth, the NOT ME program it is helping to sponsor marks the first time a health plan is paying for evidence-based diabetes prevention and working actively with pharmacists to help people with their diabetes management programs. The DPCA, which runs the program, was founded in 2010 by UnitedHealth Group, the YMCA and Walgreens.

The NOT ME program uses the findings of a clinical trial of the Diabetes Prevention Program the was led by the NIH with support from the CDC. The trial showed that lifestyle changes for people with prediabetes, which include modest weight reduction, can prevent or delay the onset of the disease by 58 percent.

http://www.healthcarefinancenews.com/news/unitedhealth-ymca-local-pharmacies-team-diabetes-prevention?topic=05,19

Technorati Tags: UnitedHealthare,algorithms,doctor,primary care,pay for performance,YMCA,Walgreens,transactions,analysis,wellness,pharmacists,Texas

FDA - H and P Recalls Povidone Iodine Prep Solutions Includes Products Under the Names of Triad, Cardinal Health, VHA, Atwater Cary and Others

The stuff is still out there and you can reference my post from July to where the Milwaukee Journal asked me about the bar codes for FDA recalls, too bad nobody does anything as recalls continue to grow. 

Recalled Wipes From Triad Still Out There in Consumer Medicine Cabinets and Possibly At Some Retail Locations-Manufacturers and FDA Need To Do A Better Job-Bar Codes

I don’t know which story is worse, all the J and J recalls or this one, both are bad by all means.  I just kind of wonder if J and J got spooked with their Baby Wipe products and tried to give this a whirl, just in case they had to recall anything as they are right in here too.  Right now the bar codes contain product information but they could be reprogrammed to give real time recall information if that were to occur.  Yes I have beat J and J over the head too with this idea in more ways than one. 

Recalls: FDA Gets the Big Luddite Award with Drug and Device Companies That Do Little or Nothing to Help Consumers-Triad Products Could Have Been Bar Coded To Scan

We all know the factory was closed by the FDA, but again the products are still floating around out there and this recall affects both consumers and medical personnel as the products are used in hospitals.  See my links at the top of the blog that has been an ongoing campaign for putting bar codes on products for recalls now for 2 years!  Will someone finally listen?  BD 

Healthcare Bar Code Posts

FOR IMMEDIATE RELEASE - August 24, 2011 - H&P industries, Inc., a manufacturer of over-the-counter drug products has initiated a voluntary recall of ALL LOTS (Lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C)of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel manufactured by H&P Industries, Inc. This recall has been initiated at the request of FDA.

H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Although H&P Industries, Inc.’s investigation and extensive testing did not find contamination, and the products met H&P Industries, Inc., finished goods specifications, H&P Industries, Inc. is voluntarily recalling all Povidone Iodine Products due to and in accordance with the Consent Decree of Condemnation, Forfeiture, and Permanent Injunction entered in the Eastern District of Wisconsin (Civil No. 2:11-cv-00319-AEG) on June 13, 2011.

Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions whereby they may have been rendered injurious to health. H&P Industries, Inc. has not ever received reports of adverse events or contamination attributed to these Povidone Iodine products.

The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.

These products were distributed in the United States. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased. Consumers with questions can call H&P Industries, Inc. at 262-538-2907 Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time.

CUSTOMERS WHO DIRECTLY PURCHASED PRODUCT FROM H&P SHOULD NOT RETURN THE PRODUCT ON YOUR OWN. Email H&P Industries, Inc. at recall.coordinator@handpindustries.com to make all return arrangements. Returns will be processed once recall acknowledgements and/or a notice of destruction have been received.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Technorati Tags: FDA,recalls,Triad Group,Bar Codes,Microsoft Tags,Cell phones,scanning,tech denial,luddites,non participants,Walgreens,CVS,Johnson and Johnson,H and P

Oral Cancer Prevention International Suing Johnson and Johnson–Oral Cancer Detection Test Product Reducing Sales of Listerine Mouthwash?

OraPharma, a former subsidiary of Johnson and Johnson signed a contract with the OCPI and then the product was immediately sidelined.  Johnson and Johnson sold OraPharma, who had the contract agreement with OCPI to a private equity firm.  This appears to revolve around the complaint that mouthwash sales of Listerine would go down as it has been in the news that the alcohol content in mouthwashes could cause oral cancer.  One thing we know though is that Listerine doesn’t remove plaque as that was challenged last year so they can’t advertise that one anymore.  BD 

Johnson and Johnson’s Next Nightmare With the FDA–Listerine Mouthwash But In Good Company with Walgreens and CVS This Time–Advertising Issues with Plaque Removal Not Founded

A company that makes an oral cancer detection kit has launched a $60m lawsuit against Johnson & Johnson, claiming that the multinational prevented its product from being sold to protect its own Listerine mouthwash, which, along with other mouth rinses, has been linked to mouth cancer.

In a complaint filed in a New Jersey court, Oral Cancer Prevention International says the multinational's executives were "leery of highlighting" the risk of oral cancer if Listerine were to be sold alongside the detection kit, as the OCPI and a division of Johnson & Johnson had previously agreed.

In February last year OCPI signed a contract with OraPharma, then part of Johnson & Johnson, the healthcare product manufacturer, to sell the company's Oral CDx Brush Test. However, almost immediately it allegedly found its product sidelined by the sales team. Johnson & Johnson sold OraPharma to a private equity firm this year.

The OCPI product was a "Brush Test" that dentists could use to determine if a common oral spot contained abnormal cells that could develop into oral cancer.

http://www.guardian.co.uk/world/2011/aug/27/johnson-johnson-sued-mouthwash-cancer-fears?

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Johnson and Johnson Extended Pain Drug (Opioid Analgesic) Nucynta ER Approved by FDA

This is the same drug, same old thing that has been working for years, come out with an extended release version and I am guessing the patent stretches out just a little further.  BD 

Approved with a risk evaluation and mitigation strategy (Follows alerts)

Aug 26 (Reuters) - Johnson and Johnson unit Janssen Pharmaceuticals got U.S. regulatory approval to market its oral pain drug Nucynta ER for moderate to severe chronic pain when an opioid analgesic is needed for extended use.

Nucynta ER is an extended-release version of the company's already approved pain drug Nucynta.

The drug has been approved along with a risk evaluation and mitigation strategy, also known as REMS, to educate prescribers about the potential for abuse, misuse, overdose and addiction from exposure to the drug.

http://www.reuters.com/article/2011/08/26/jnj-idUSL4E7JQ2KX20110826

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FDA Approves Pfizer’s XALKORI® For Lung Cancer Patients Local or Metastatic Non-Small Therapy-Will It Affordable?

This is the first drug in 6 years to treat lung cancer but we seem to have a trend lately of the drugs being very expensive and not to mention the current shortage of generic drugs that treat cancer.  A quick search of the internet says the cost will be $9600 a month so again that runs into some money pretty quickly.   Now that we know the cost, please read the link below on how a new “scoring” algorithm has been developed to tell people how long they have to live…keep an eye out on this as we hope it will not be used to determine who gets care and who does not.  Actually the link below discusses how formulas are being used both constructively and the potential for abuse so read up as everyone is combining data from all different types of sources today and we have ethics issues forming rapidly.  BD 

Prognostic Scoring Analysis System Can Tell Doctors How Long Cancer Patients Have to Live; Danger Zone As Far as Misuse With Drug and Treatment Access for Patients

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved XALKORI® (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test. The effectiveness of XALKORI is based on objective response rates (ORR) and, as XALKORI received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.

“The development of XALKORI – from publication of the discovery of the ALK fusion gene in NSCLC to FDA approval in just four years - is a remarkable feat in the oncology world and reinforces the importance of collaboration among academic research, pharmaceutical, diagnostic and regulatory organizations.”

“Overall, lung cancer is responsible for more deaths each year worldwide than any other type of cancer. XALKORI is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease,” said Ian Read, president and chief executive officer of Pfizer. “The acceleration, collaboration and critical focus of the XALKORI clinical development program reflect Pfizer’s Precision Medicine approach to advancing our pipeline and strengthening our innovative core to deliver medicines that matter most.”

http://www.businesswire.com/news/home/20110826005815/en/U.S.-Food-Drug-Administration-Approves-Pfizer%E2%80%99s-XALKORI%C2%AE

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Stem Cells Extracted from Fat Created New Bone and Saved Patient from Amputation–Regenerative Medicine

This is some pretty amazing technology with what they were able to do with stem cells here and save the woman who was in a wheelchair from amputation, and on top of that, she’s walking again.  There are so many amazing areas in regenerative medicine that are evolving and this is one of them.  BD

WBAL - Researchers in Maryland are using stem cells from fat to grow new bone.

In January 2009, 53-year-old Susan Cossabone was in a terrible head-on collision. Her injuries made her fear that she'd never walk again, much less ride her beloved horses at her horse farm in New Jersey.

"I thought I would lose the leg. If you could have seen it when they cut off my favorite jeans -- you could just see bones sticking and flesh. You couldn't see much of a leg," she said.

For a while, it looked as though her leg would require amputation, doctors said.

http://www.ksdk.com/news/article/273723/9/Doctors-use-stem-cells-extracted-from-fat-to-create-new-bone-tissue

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Cook Medical Introduces Endoscope With an HD Camera Attached- Portable Imaging System for Urologists

 Envisionier Medical Technology, Inc. is the manufacturer of the viewer.  The endogo HD easily attaches to an endoscope to capture, store, and share high definition endoscopic images and video instantly with patients, their families and physicians following a procedure.  This device could also potentially reduce costs by eliminating the need for additional procedures.  Not only do we get to see inside of everything today, but now it’s also in HD. 

In addition the information can also be send to an EHR program from the web storage services of eGoWorks™ in the cloud, and it is touch screen enabled too.  What is pretty funny is they have a game where you can use the endoscope animated image and shoot down the old technology.  BD 

Press Release:

Bloomington, Ind., August 22, 2011 – Cook Medical recently launched the endogo^® HD Portable Endoscopic Imaging System by Envisionier Medical Technology, Inc. The endogo HD has the ability to capture, store and share endoscopic images, making it possible for doctors to share information with patients instantly, simplify collaboration between colleagues and potentially reduce costs by eliminating the need for repeat procedures.[1]

With high definition video and still-image capture capabilities in a compact, portable setup, endogo HD allows a physician to share and review exam findings with the patient or family immediately following the exam, at the patient’s bedside or in a waiting room. A resident can also share captures with the attending physician, which may reduce the need for repeat procedures. With the endogo HD, OR imaging capabilities can now be available throughout the facility, wherever a procedure is performed. The combination of data acquisition, storage, management and the synchronization of patient folders in an easy-to-use Web application makes it possible to send an image or video over a secured connection to a referring doctor outside the facility.

Equally beneficial is the compatibility of the endogo HD with EMR systems. eGoWorks™, the online data storage and collaborative software that is compatible with the endogo HD, allows the data acquired with the portable camera to be used within EMR systems. 

 

“We are excited about endogo HD because it truly underscores Cook’s commitment to physicians and their patients,” said Jean-Marc Creissel, global leader of Cook’s Urology business unit. “The technology simplifies the process of storing and sharing medical images. The benefits around care, ease of use and potential cost savings are significant because this technology streamlines how physicians interact with each other, their patients and external facilities.”

The endogo HD easily couples with both flexible and rigid endoscopes, transforming the captured images and video from analog to digital. The camera also has built-in light source optimization for high-quality imaging and a 3.5 inch removable LCD touch-screen (eGo™) for multimedia playback.

¹ Lemonnier LA, Treadway CK, Lin HS, et al. The feasibility of telemedicine in fiberoptic laryngoscopy. Laryngoscope. 2010;120(suppl S3):S10.

About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter @cookmedicalpr and @CookUro.

 

Technorati Tags: endogo HD,Cool Medical,medical devices,HD,medical records DOD,data storage,healthcare,Health IT,urology

Allergan Gets FDA Approval for Using Botox To Treat Overactive Bladders

Botox seems to be a shining star for relief in many areas of late and last year another type of botox was approved to treat cervical dystonia. In March of last year the FDA also approved the use for muscle spasms in the hand and wrist area.  BD

FDA Approves Xeomin® A Botulinum Toxin Type A (Botox)To Treat Cervical Dystonia

FDA Gives the Ok for Botox To Be Used for Muscle Spasms In the Wrist and Finger Areas of the Hand

Botox gives grandmother her voice back

Allergan Inc. won U.S. clearance to market the wrinkle smoother Botox as a treatment for urinary incontinence.

The Food and Drug Administration approved the drug for people with overactive bladders who have neurologic conditions such as multiple sclerosis and spinal cord injuries, the agency said today in a statement. The medicine is injected into the bladder to increase its capacity by relaxing muscles.

Botox, also used to reduce facial wrinkles and treat neurological disorders, is the Irvine, California-based company’s top product with $1.4 billion in revenue last year. Sales of the drug for incontinence in people with MS and spinal cord injuries may reach $40 million in 2017, Seamus Fernandez, a Boston-based analyst at Leerink Swann & Co., said today in a note to investors.

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FDA Approves Ellipse Technologies to Market Remote Control Leg Lengthening Device

This is not surgery to make your lets longer, that’s another topic and company but rather this is rather an orthopedic device to remotely control implants in your legs for bone lengthening.  If you want to read about surgery to be taller and all the pain and suffering and bone breaking, then check out the link below. 

Surgery to Become Taller – Cosmetic Limb Lengthening (CLL)

Spinal scoliosis in children is the first targeted market and that sounds like a very good place to begin.  The company is located in Irvine, California and the device already has the European CE mark of approval. 

“The pictures are pretty interesting though and it looks kind of sci-fi looking if you will or like a big hardware type of tool.  From the website below:

Our initial products are non-invasively adjustable implants used to restore proper anatomic position and alignment of the spine and long-bones. The key to Ellipse Technology is the non-invasive magnetic interaction between the implant and the External Remote Controller “ERC”, a portable, hand held unit that uses permanent rare earth magnets to automatically modify the length of the implant through the touch of a switch. The amount of lengthening or shortening of the MAGEC or PRECICE implant can be seen immediately on the ERC display module.”

This seems pretty wild as you use the device to automatically modify the length of the implant with a switch on the hand held unit and I can guess this is going to cost a few dollars too when available.  BD

Press Release:

IRVINE, Calif.--(BUSINESS WIRE)--Ellipse Technologies, Inc. (“Ellipse”) announced today that it has received FDA marketing clearance of the Company’s PRECICE^TM Limb Lengthening device in the United States. Limb Lengthening procedures are used to treat a number of medical conditions, including legs shortened due to congenital abnormalities, major fractures of one of the legs and shortened leg bones due to other medical diseases, such as cancer.

“Our remote control technology was a huge hit among attendees. The PRECICE System is easily recognized as a game-changer for patients suffering from limb deformities”

Ellipse has initiated clinical use of the PRECICE devices and plans an international product launch during the first half of 2012.

Commenting on the PRECICE technology, Stuart Green, M.D., Professor of Orthopedic Surgery, University of California, Irvine, said, “The PRECICE Technology will make it possible to use externally controllable implants for patients who require bone lengthening. In the future, this technology will likely be adapted to many other orthopedic applications.”

PRECICE^TM Remote Control Limb Lengthening System

The initial PRECICE devices will be used in leg limb lengthening procedures of the femur and tibia bones. Rather than using adjustable external fixation systems which are attached to the leg bone through long-term openings in the skin, the PRECICE REMOTE CONTROL TECHNOLOGY provides an internal implant adjusted to lengthen the leg bones via non-invasive methods from outside the body. Ellipse and its scientific advisors believe the PRECICE devices will not only provide a less-invasive approach to these procedures but also significantly reduce the potential for complications (e.g., infections) during the healing and recuperation period.

The PRECICE System was recently unveiled at the Limb Lengthening and Reconstruction Society (LLRS) Annual Meeting in Chicago. “Our remote control technology was a huge hit among attendees. The PRECICE System is easily recognized as a game-changer for patients suffering from limb deformities,” said Ed Roschak, Ellipse Chief Operating Officer.

Ellipse is continuing to develop the PRECICE technology for orthopedic fracture management and trauma applications.

MAGEC^TM Remote Control Spinal Deformity System

Ellipse has developed the MAGEC (MAGnetic Expansion Control) Technology for minimally invasive, and ultimately non-invasive, orthopedic deformity prevention and management. MAGEC Technology is a breakthrough medical device technology capable of non-invasively adjusting implants within the human body from outside the body via remote control. The adjustment of the device can also be reversed. The first application for this technology is for the treatment of spinal scoliosis in children.

With the MAGEC Technology, a single minimally invasive surgical procedure is completed. Then, during a series of routine outpatient visits, the physician will dynamically adjust the MAGEC Technology from outside the body via the MAGEC System’s External Remote Controller (“ERC”), thus eliminating the need for multiple highly invasive surgical procedures which are required with currently marketed, conventional products.

The MAGEC System is CE-Marked and Ellipse recently initiated a product launch at the International Meeting for Advanced Spine Therapies (IMAST) in Copenhagen, Denmark. Commenting on this launch, Mr. Roschak said, “The response to MAGEC from the international spine community at IMAST was profoundly positive. The vast majority of physicians told us the Ellipse breakthrough technology will be of great benefit to their patients with spinal deformity. Now, we can move forward with the international rollout of the MAGEC System.”

Ellipse Technologies, Inc. is a privately-held medical device company located in Irvine, California. The Company is focused on developing its implantable remote control technology platforms to include innovative and state-of-the-art treatments for a broad spectrum of spinal and orthopedic deformity applications, orthopedic trauma and fracture management.

The MAGEC^TM System is not currently available for distribution in U.S.

http://www.businesswire.com/news/home/20110823006435/en/Ellipse-Technologies-Announces-FDA-Clearance-Market-PRECICETM

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Former Duane Reade Drug Store Chain CEO Sentenced to 3 Years in Prison for Exaggerating Company’s Income

The New York City drug store chain was purchased by Walgreens back in February of 2010 but the time where he was in violation on stating company value goes back to the years 2000 to 2004.  Walgreens paid $1.1 billion for the acquisition of Duane Reade Drugs and was formerly owned by private equity firm Oak Hill Capital Partners.  BD 

Walgreens Buys Duane Reade Drug Stores – Gives Them A Big Footprint in New York

Mr. Cuti was convicted in June 2010 of securities fraud after a two-month trial in which jurors concluded he had plotted to falsely inflate the income and reduce the expenses that Duane Reade reported to investors. The Securities and Exchange Commission said Mr. Cuti and another executive at the company overstated the chain’s pretax income by $17.5 million between 2000 and 2004.

Judge Batts acknowledged that Mr. Cuti had rescued Duane Reade from the brink of bankruptcy, helping it grow into the metropolitan area’s largest drugstore chain, but she said he also “bullied people into committing fraudulent acts to make the company look like it was doing better than it actually was.”

http://www.nytimes.com/2011/08/23/business/cuti-former-duane-reade-chief-sentenced-in-fraud-case.html?smid=tw-nytimesbusiness&seid=auto

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