PLEASE READ , BY DR. O. IMPORTANT

[obsidianom]

I IMPLORE ALL DIALYSIS AND RENAL PATIENTS TO READ THE THREAD ON NXSTAGE ONTHE TOPIC " SAK RECALL" .PAGE 4  IS THE MOST IMPORTANT.
YOU WILL FIND OUT HOW DIALYSIS PATIENTS WERE CONTAMINATED BY ALUMINUM IN DIALYSATE FOR 9 MONTHS AND HOW THE COMPANY MANUFACTURING IT IS ROCKWELL . ROCKWELL IS PUTTING OUT  NEW DRUG FOR HEMOGLOBIN FOR KIDNEY PATIENTS THAT WAS ALLEGED TO NOT WORK. THEY HAVE SUNK OVER $60 MILLION INTO IT . THEY ALSO PRODUCE A GENERIC CALCITRIOL.  THEY HAVE SOME BAD PRESS.
NXSTAGE SIGNED ON WITH THEM FOR DIALYSATE AND RIGHT AFTER THE PROBLEM DEVELOPED.   WATCH OUT .   
ALL RENAL PATIENTS SHOULD SEE THIS .
AS THIS NEW DRUG WILL GO INTO THE DIALYSATE IN CLINICS IN CENTER, IT COULD EFFECT EVERY DIALYSIS PATIENT.


'Rockwell’s drug Soluble Ferric Pyrophosphate (SFP) is an iron salt administered to dialysis patients through dialysate to replace the iron lost during dialysis'

[Zach]

Adding links would be of help.
Thanks.
 

[Maggie and Jeff]

http://ihatedialysis.com/forum/index.php?topic=31141.0

[Zach]

'Rockwell’s drug Soluble Ferric Pyrophosphate (SFP) is an iron salt administered to dialysis patients through dialysate to replace the iron lost during dialysis'

I mean to this and other outside IHD source quotes.
Thanks so much.
 

[obsidianom]

http://sharesleuth.com/investigations/2012/06/former-rockwell-medical-executive-alleges-sec-violations

[obsidianom]

http://www.drugs.com/nda/triferic_140324.html

[Zach]

Thanks again, Dr. O.
 

[Hemodoc]

That is interesting, but one person on IHD had elevated Aluminum levels in late February or March of 2013 and noted that on a post dated 4-4-13 on IHD. That wouldn't explain his connection to all of this. The Rockwell connection may be a red herring or there might be something to it. But if they didn't start shipping product until May 2013 from Rockwell, then we are probably still looking for the real culprit.

Bottom line, NxStage needs to disclose the who, what and where in this incident so patients can  know and understand exactly what is going on.

Interesting story, not sure if this is the smoking gun or not. It may be premature without further information to state that Rockwell is the culprit. Once again, according to the timeline of when NxStage says the issues started, the dates of the Rockwell agreement and taking into account the other IHD member who already had issues for "for two months" on his post dated 4-4-13 will have to be explained as well. I don't believe the Rockwell connection according to the dates is the culprit, but we simply lack clarity on all the issues.

Yes, it is an interesting lead to pursue, but is it the whole answer? We will have to wait and see, but NxStage simply needs to be more open on the who, what, when and where of this whole issue.

[Hemodoc]

Angie had symptoms of a "metallic taste" in the middle of March just as speedy1wrc. I had severe metallic taste while my aluminum levels were at their highest as well. If this is caused by the aluminum which is likely, then we have to know where those lots in March were manufactured. 

http://ihatedialysis.com/forum/index.php?topic=28697.msg454709#msg454709

According to what you have recored, Rockwell didn't start shipping until sometime in April or May. Did NxStage keep their other plant up and running and the Rockwell issue is just a red herring? Once again, we need full disclosure from NxStage. Speculation won't get us where we need to go, but I do agree the Rockwell connection is something that does need follow up on. I am just wondering about the timing with the Rockwell agreement signed March 8, 2013 and symptoms starting mid March. Is the Rockwell connection the correct answer or is it going to lead us away from the correct answer?

[obsidianom]

My wife had 11 of the contaminated cases.

[Dannyboy]

Bump

[obsidianom]

Actually Rockwell could have started anytime after March 8. It is possible even before that as we dont know who was manufacturing it bafore march 8 anyway. For all we know it still could have been Rockwell. This aluminum issue seems to have started around March in people here at IHD .

[obsidianom]

NXSTAGE

These excerpts taken from the NXTM 10-K filed Mar 16, 2009.
Manufacturing

 The manufacture of our products is accomplished through a complementary combination of outsourcing and internal production. Specifically, we manufacture our System One Cycler and some PureFlow SL hardware, and assemble, package and label our PureFlow SL disposables within our facility in Fresnillo, Mexico. We manufacture components used in our System One cartridge assembly, and assemble the System One disposable cartridge and some blood tubing sets, Medics and transducer protectors in our facility in Tijuana, Mexico. We manufacture our dialyzers in our Rosdorf, Germany facility. We outsource the manufacture of premixed dialysate, needles, some blood tubing sets and some PureFlow SL hardware.
 
 

 We have a molding facility in Modena, Italy, which molds components used in the products we manufacture ourselves in Tijuana, Mexico, as well as supplies the molded components for finished goods manufactured by Kawasumi Laboratories, Inc., or Kawasumi, as described below.
 
 

 We have single-source suppliers of components, but in most instances there are alternative sources of supply available. Where obtaining a second source is more difficult, we have tried to establish supply agreements that better protect our continuity of supply. These agreements, currently in place with several key suppliers, are intended to establish commitments to supply product. We do not have supply agreements in place with all of our single-source suppliers.
 
 

 We have certain agreements that grant certain suppliers exclusive or semi-exclusive supply rights. We contract for the manufacture of the majority of our finished goods of ReadySet blood tubing sets and all our needles from Kawasumi, headquartered in Tokyo, Japan, with manufacturing facilities in Thailand. The current agreement with Kawasumi for the manufacture of blood tubing sets expires in January 2010. Under the terms of this agreement, we supply Kawasumi with molded component parts and Kawasumi in turn uses these components to manufacture finished goods blood tubing sets, which are then purchased by us. We have committed to purchase from Kawasumi a minimum quantity of blood tubing sets over the term of the agreement. We believe that this minimum purchase commitment is less than our anticipated requirements for blood tubing sets.
 
 

 We also have an agreement with Kawasumi for the manufacture of needle sets. Virtually all of these needle sets rely on our patented guarded needle set technology. In February 2007, we agreed with Kawasumi to extend their needle set supply agreement through February 2011. We have committed to purchase from Kawasumi a minimum quantity of needle sets over the three-year extended term of the contract. We believe that this minimum purchase commitment is less than our anticipated requirements for needles.
 
 

 In January 2007, we entered into a long-term supply agreement with Membrana pursuant to which Membrana has agreed to supply, on an exclusive basis for a period of ten years, the capillary membranes that we use in the filters used with the System One for ten years. Membrana has agreed to pricing reductions based on volumes ordered and we have agreed to purchase a base amount of membranes per year. The agreement may be terminated upon a material breach, generally following a sixty day cure period.
 
 

 We purchase bicarbonate-based premixed dialysate from B. Braun Medizintechnologie GmbH, or B. Braun, and our lactate-based premixed dialysate from Laboratorios PISA, or PISA. We have a supply agreement with B. Braun that obligates B. Braun to supply the dialysate to us through 2009 in exchange for a minimum purchase commitment, which we believe is less than our anticipated requirements. The contract may be terminated upon a material breach, generally following a 30-day cure period. Our supply agreement with PISA terminated at the end of 2008. We are currently purchasing products from PISA on a purchase order basis as we negotiate a new agreement with PISA.

[obsidianom]

http://www.compliance-alliance.com/wp-content/uploads/2010/11/Establishment-Inspection-Report-for-Rockwell-Medical-Technologies-Inc.-manufacturer-of-Dialysate-Concentrates.pdf
 
This link is to a MAJOR violation found at one of the Rockwell plants in SC. making DIALYSATE.  There were numerous serious violations and the customer complained to the govt. This is from a freedom of info act.
This should scare the hell out of all dialysis patients. It may be a few years old but the CEO is still the same guy, Mr Chioini.
 

[jeannea]

I have experience reading and responding to FDA Deficency Reports. Sometimes the way they write it makes it sound worse than it is. This one is actually really bad. There are some serious issues in there.

I hope no one was really hurt badly.

[obsidianom]

Some of the problems involve not testing water for cyanide and chloramines, and they found unacceptable endotoxin levels. There were open batches exposed to air in  large vats, unlabeled product delivered, exposed insulation in the building, and many other issues. This comapny is large and has several plants in the US to produce dialysate. They signed on with Nxstage in 2013 and now we have contaminated dialysate with unacceptable aluminum levels.

[jeannea]

It takes some serious neglect to get to that point. I worked in generic pharmaceuticals. Of course if you scrutinized the plant there were always minor issues. But to have insulation coming out and unlabeled product: it takes a lot of neglect to have that. One thing I noticed is they only had one person reviewing batch reports. That's unacceptable even in a small plant. That one person can't stay on top of all the issues.

My real question is this. In order for NxStage to use their product, NxStage is required to do their own audit of that plant. Did they not do the audit? Did they cover up issues? Something bad happened.

[Simon Dog]

I have experience reading and responding to FDA Deficency Reports. Sometimes the way they write it makes it sound worse than it is. This one is actually really bad. There are some serious issues in there.

I hope no one was really hurt badly.

It sounds like they need Heisenberg to oversee operation.

[Tío Riñon]

I'm a little confused.  Does this affect only NxStage patients, only in-center patients, or all patients?  Does all dialysate have this product from Rockwell added?

If it affects all of us, what do we look for in or on our bags?  If you're looking for us to support you, what needs to be done?

[obsidianom]

It is a twisted web. But I will try my best here.
Rockwell is huge . They produce meds for dialysis patients such as generic calcitriol and are coming out with a new drug for anemia called Triferic. They also produce dialysate .
Now Nxstage sigened with them back around early 2013 to produce dialysate for their machines. Around the same time the dialysate became contaminated with excess aluminum. We are trying to unravel whether it was Rockwell that produced it. 
Now Rockwell has been accused of some serious violations. Their medical doctor researcher on the new drug Triferic accused them of falsifying reports to the FDA on the product . He claimed it didnt work and they are hiding this. If it gets final approval it can be added to your dialysate in center to treat anemia. That is where all patients should be aware as if it doesnt work you are being given a bad drug in the dialysate directly.
The other issue is that at least in one rockwell plant in the US they were cited for some very serious violations . These could easily lead to contaminated dialysate and possibly medication ? If one plant was that bad, who knows what else is going on. It puts in question everything they produce.
There is also the large debt they have taken to produce the drug Triferic . They took the money from Hercules co.(betweeen $40 million and $60 million) to finance the research and development. If the drug fails they are in deep debt . That can often be a reason for some questionable activity . Now these are just allegations only but they are enough to warrent further looking into the whole mess.
AS to what to do.-----I would avoid their new drug Triferic when it comes out. Let it come out and see what it really does for a couple years before considering using it yourself. ASk your doctor NOT to use it on you. It goes dirctly into the dialysate  in center .
I would personally not use their generic calcitriol just out of protest. Most generics have a manufacturer listed.
For now we are still looking into the whole Nxstage -Rockwell connection and will come forward if/when we have more.  Nxstage needs to open up some also with more info on what occurred and how, and how they plan to avoid it in the future.

[obsidianom]

Rockwell Medical Inc.

Traded as
 
NASDAQ:RMTI
 
Pharmaceutical Industry
 
Founded
 
1995[1]
 
Headquarters
 
United States
 
Products
 
Pharmaceutics
 
www.rockwellmed.com
 

Rockwell Medical Inc. is an international pharmaceutical company focusing on the development and commercialization ancillary hemodialysis products, for treatment against diseases such as end-stage renal disease, iron deficiency, chronic kidney disease (CKD), etc. The company's products mainly sell to the United States, Asia, Europe and Latin America.[2] The company was formerly named Rockwell Medical Technologies, Inc., and is now a publicly traded company on NASDAQ under the symbol "RMTI".
 
This company performed top during 2013, among biopharmaceutical companies in the US and has two largest dialysis centers in the US, DaVita (DVA) and Fresenius (FMS), as the buyer of its products.[3]

[obsidianom]

All FROM Rockwell

Hemodialysis Concentrates

Acidified Concentrate Powders and Liquids
Dri-Sate® Dry Acid Mixing System
Formulas (45X / 36.83X / 35X)
RenalPure® Liquid Acid
Formulas (45X / 36.83X / 35X)

Bicarbonate Concentrate Powders and Liquids
RenalPure® Powder Bicarbonate
Formulas (45X / 36.83X / 35X)
SteriLyte® Liquid Bicarbonate
Formulas (45X / 36.83X / 35X)

[obsidianom]

Parties Negotiate Multi-Year Supply Contract

WIXOM, Mich., March 28, 2011 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that it has executed a multi-year supply agreement with DaVita Inc. through 2013.

 Mr. Robert L. Chioini, Chairman and CEO of Rockwell Medical, stated that, "We are pleased to have executed this multi-year supply agreement with DaVita, further strengthening our long-standing business relationship. We are proud to provide high-quality products and premium customer and delivery service to dialysis providers committed to offering top-level patient care, such as DaVita."

[obsidianom]

SOME OF YOU MAY HAVE HAD TRIFERIC TESTED ON YOU IN CENTER ACCORDING TO THIS PRESS RELEASE.

Rockwell Medical Announces Largest Dialysis Organizations in U.S. to Participate in Phase III CRUISE Studies

SFP Pivotal Studies to Include Leading Dedicated Research Sites

WIXOM, Mich., Jan. 25, 2011 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that the clinical research divisions of the two largest dialysis companies in North America have signed agreements to participate in the Company's pivotal Phase III CRUISE studies using Soluble Ferric Pyrophosphate (SFP) as a continuous iron replacement therapeutic.

 Mr. Robert L. Chioini, Chairman and CEO, stated, "We are pleased to have these companies participate in our pivotal SFP Phase III studies. Together, they provide ongoing dialysis treatment to approximately two-thirds of hemodialysis patients in the U.S.  We expect their access to a large number of patients and their expertise in clinical research will enable us to achieve timely enrollment and complete a successful Phase III clinical program."

[obsidianom]

Sharesleuth also noted that Rockwell Medical took the unusual step last November of extending the life of 400,000 warrants it had issued in the fall of 2008 to a consultant who was later found to have participated in a massive fraud scheme at another public company.
 
That consultant, Michael J. Xirinachs, was one of Rockwell Medical’s co-founders.
 
The federal judge hearing the SEC’s civil case against Xirinachs and his company, Emerald Asset Advisors LLC, last week ordered them to pay as much as $10 million in disgorgement, interest and fines