Mr. Joe Atkins RN, MBA, CNN, CHT

GLG News by Mr. Joe Atkins RN, MBA, CNN, CHT, Chief Executive Officer

GLG News is now G+ Insights

G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.

FDA Restrictions on ESA's Will Have Minimal Effect of EPO Usage.

August 4, 2008

Analysis of:Amgen Told to Reword Drug Label | www.nytimes.com

1)  Concerns over the new FDA restrictions on ESA's is being overstated. 2)  Amgen will continue to do well in the ESA market place, in spite of these changes. 3)  J&J will receive the brunt of these changes, strictly because of their market concentration in the oncology market. 4)  Amgen will continue on as the "King of US ESA's".

Veterans Admininstration Sets The Standard for Electronic Medical Records: Why Re-invent The Wheel?

August 4, 2008

Analysis of:Nationwide EHR Implementation Price Tag Estimated at $150 billion | www.govhealthit.com

The VA has already won many awards for an electronic medical records system, which tax payers have already paid for. Adopting the VA "CPRS" program would save the taxpayers and the private sector hundreds of billions of dollars.

FDA: Chinese Manufacturer of Tainted Heparin Involved in Fraud.

April 30, 2008

Analysis of:UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com

First, and foremost, the only working link for this article can be found at: http://www.reuters.com/article/domesticNews/idUSWAT00934620080415?feedType=RSS&feedName=domesticNews Although there is no proof offered in the article to substantiate the suggestion of fraud, there is enough circumstantial evidence to suggest that it is so.

FDA Fees Must Be Increased to Fund Inspection of Chinese Products.

April 30, 2008

Analysis of:FDA fees eyed to boost food, drug safety | www.usatoday.com

One only has to read about the Heparin debacle, which has killed, at least, 81 Americans, to realize that there is a serious issue with the quality of medicines produced in China.  Manufacturing of medical food and consumer goods in China is growing at such a rate, the Chinese government has neither the resources or the will to maintain adequate inspection of quality control.  The only way it's going to be done is if our FDA becomes involved, hence the increase in FDA fees.

Who to Blame for Waste in the Medical Industry? Who's on First?

April 30, 2008

Analysis of:The Price of Excess: Identifying Waste in Healthcare Spending | blogs.wsj.com

It's easy to point fingers of blame and this article does that, very well.  According to the "annalysis" everybody is to blame.  And, they're right, everyone is to blame, but where the article fails is the authoris inability to point out a real solution to the problem of wasted dollars spent on the American healthcare system.

Anemia Drugs Have Been Abused for Profit!

April 30, 2008

Analysis of:WellPoint likely to follow FDA on anemia drugs | www.reuters.com

Over the last year, it has become clear that the over-use of anemia drugs for cancer and renal failure has become a problem.  The reason can be sumed up in one word, which is profit.

Base Product in Baxter's Heparin Came from China!

March 24, 2008

Analysis of:Tainted Blood Drug to Face Import Tests | www.nytimes.com

1)  Baxter was producing 50% of the worlds heparin requirements, which provided short term anticoagulation for hemodialysis and various interventions for cardiovascular disease. 2)  The base product of heparin comes from porcine intestines. 3)  The base product of Baxter's heparin was produced in a non-FDA inspected plant in China. 4)  The Chinese company that produced the "fake" heparin was partly, American owned. Bottomline:  Abraxis and APP are now the main providers of heparin in the United States, and possibly, the world.

Amgen Stock Set to Take a Fall!

March 24, 2008

Analysis of:Panel Seeks New Limits on Anemia Drugs | www.nytimes.com

1)  Amgen's and J&J's ESA products are going to continue to receive more black box warnings from the FDA. 2)  A federal Judge may force Amgen to accept a royalty from Roche, allowing their CERA ESA to come to market in the USA. 3)  Their is potential for more problems to arise, in the way of side effects associated with EPO products in patients with Chronic Renal Disease and End Stage Renal Disease. 4)  Affymax, makers of a new drug called Hematide, is in phase III human trials and has the potential to finally beat Amgen's ESA patents. My strong suggestion:  Investors should buy Affymax stock.

Chinese Heparin Debacle May Cause World Wide Shortage for Dialysis Providers

February 19, 2008

Analysis of:China Plant Played Role | online.wsj.com

Although patient deaths are of grave concern, the impact of a heparin shortage stand to put around 400,000 US dialysis patients at risk.  Heparin is the "oil of hemodialysis" and without it, hemodialysis would come to a standstill. There are alternatives available, such as Andiomax and Lovenox, however, they are not practical for the hemodialysis community owing to the fact that they do not have an antagonist, such as propomine sulfate, to counteract their anticoagulative properties. Since Baxter presently produces 50% of all the heparin in the world, and they are vunerable, it would behove their competitors to increase production and corner the market.

DNAPrint Genomics "Super EPO": New Competition for Amgen on the Horizon!

August 14, 2006

Analysis of:DNAPrint Pharmaceuticals Completes the Development of a Second Assay for Its Anemia Drug | biz.yahoo.com

Clearly, U.S. ESRD, CKD and oncology clinics, physicians and patients are tired of being held hostage by Amgen.  If DNAPrint is able to bring their new "Super EPO" to market, it would finally provide a competitive alternative to Amgen's high priced EPO products, bringing the cost of anemia management back to manageable levels.

To give you an idea of how much Amgen's anemia management products costs, it's the second largest cost for dialysis providers in the United States.  To put this in perspective, the top three costs for dialysis providers are:

1.  Staff
2.  Amgen's anemia management products Epoietin Alpha and Arenesp (cost equals half of the cost of staff, including benefits and wages).
3.  All the disposables required to carry out the primary mission of of ESRD providers, which is the dialysis treatment, itself (cost, including everything required to carry out a dialysis treatment, is less than a third of what providers are paying for Amgen's drugs).

Amgen will, most likely, win their patent dispute against Roche's CERA!

June 15, 2006

Analysis of:ITC agrees to investigate Roche’s importation of CERA | www.nephronline.com

Amgen has already beaten two threats to their EPO patents, one with Chugi-UpJohn and the second with TKT/Aventis.  Both companies had products that were unique enough to get around Amgen's patents, but it didn't happen.  In light of the similarities between Arenesp and CERA, I don't believe that Roche has any chance of getting around Amgen's EPO patents.

Renal Solutions Receives FDA Approval for New Portable Dialysis Machine

June 13, 2006

Analysis of:FDA Approves Latest Version of Renal's Dialysis Machine | groups.msn.com

1) This dialysis machine provides many practical advantages over the Aksys and NxStage home hemodialysis machines.
2) Renal Solutions Allient system's basic technology is a new spin on technology from NASA's Mercury Capsule technology, which has been tried and proven in the dialysis industry for many decades.
3) This system is truly portable. As long as you have six liters of water and an electricle outlet, you can do your dialysis treatment anywhere in the hospital, at home, or even on vacation at an RV camp.
4) The experts that have been drawn into Renal Solution's senior staff have decades of experience with the Allient technology, again, giving this company a tremendous advantage over NxStage and Aksys.
5)  I've actually used the older form of this technology, myself, many years ago, and was very sorry when the technology was allowed to sunset.  The technology is so simple that I was able to train home dialysis patients to take the machine on vacation, in the back of there RV's and this was back in the 70's and 80's.  With the vast improvements in the technology of the Allient system, this machine is poised to take over the home and acute hemodialysis market. 

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