I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: General Discussion => Topic started by: obsidianom on May 23, 2014, 08:03:01 AM
-
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'
-
Adding links would be of help.
Thanks.
8)
-
http://ihatedialysis.com/forum/index.php?topic=31141.0 (http://ihatedialysis.com/forum/index.php?topic=31141.0)
-
'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.
8)
-
http://sharesleuth.com/investigations/2012/06/former-rockwell-medical-executive-alleges-sec-violations
-
http://www.drugs.com/nda/triferic_140324.html
-
Thanks again, Dr. O.
8)
-
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.
-
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?
-
My wife had 11 of the contaminated cases.
-
Bump
-
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 .
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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?
-
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.
-
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]
-
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)
-
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."
-
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."
-
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
-
PLEASE READ MY PREVIOUS 6 POSTS ON THE PAGE BEFORE THIS BEFORE YOU READ THIS.!
THIS IS ABOUT TRIFERIC THE DRUG TESTED IN CENTER ON SOME OF YOU AND NOW TO BE RELEASED TO USE ON YOU!!!!
SFP IS TRIFERIC!!
Yocum alleged in his suit that Rockwel Medical:
–falsely claimed that the results of its earlier Phase IIb studies of SFP were positive, despite the fact that they failed to demonstrate that the treatment was effective.
“Essentially, except for showing an absence of safety issues, the study was a failure,’’ the complaint said.
Yocum said in the suit that he and other experts warned Chioini that the results of the study did not provide enough data on efficacy or dosing to proceed directly to Phase III clinical trials.
The company nevertheless issued a press release on Feb. 25, 2010 that was headlined “Rockwell Announces Positive Phase IIb Clinical Data.” The release said the study “met its objective of determining the dosing of SFP for the planned Phase III trials.’’
-
Rockwell hopes to generate hundreds of millions of dollars on Triferic. I read thier plan . They hope to put this in the dialysate in centers and they beleive it will cut the amount of EPO needed.
This should scare EVERY dialysis patient. If the clinics can cut EPO they would save money based on the medicare bundling of payments. There will be an economic push to make this work at OUR expense. WATCH OUT! Triferic will replace EPO is the Rockwell plan. The only problemis ,----It may not work at all according to their original researcher who was fired for speaking the truth. All dialyis patients will be guinea pigs potentially in this hundreds millions dollars gamble. If it fails to work ANEMIA may make a comeback . EPO is expensive. What do you all think will occur??
-
Here you go talking about me and I didn't even know this thread was here. Lol.
The issues:
Patients exhibited high aluminum levels as far back as March of 2013. Efforts were made to determine the cause, of which none was found on the patient side. This WAS reported to NxStage although their recall statement indicates the contrary. NxStage categorically stated that it could not be from the dialysate. Dialysate with high aluminum was discovered and a recall was issued.
As patients and caregivers we are outraged that we were exposed to the high aluminum, and for the extended period of time. Many of us have been experiencing symptoms for quite a long time and are also concerned about long term harm. All we have gotten from NxStage is a "sorry for the inconvenience". That is not acceptable.
Dr O has been following upon the trail of evidence. We all should be doing are own digging and research. Strength in numbers. We all need to push NxStage to come clean and put procedures in place to ensure this can't happen again. We need to know if this is the extent of the problem or it is bigger than what we have been told. Being when I started with high levels I strongly suspect we have only seen the tip of the iceburg.
I have calls in to Rockwell and NxStage. My expectations are low, but I am trying to get more information. We'll see.
-
So does this mean that dialysis patients across the country have been unknowingly participating in a drug study with Triferic being added to their dialysate? Isn't that illegal? Or, is there something in the paperwork we all sign saying that we are okay with being drug company guiniea pigs? Usually when one participates in a drug study, one gets compensated. How have these tens of thousands or hundreds of thousands of patients been compensated for being a drug trial guniniea pig??? And, how is it "legal" to force those who have to undergo life saving treatment to "participate" in a drug trial??? Am I reading this right? Where is the OUTRAGE???
:stressed;
KarenInWA
-
Being HHD that aspect doesn't apply to me, but it certainly caught my attention for the same concerns you expressed. I am curious if it may start to apply to dialysate provided outside of center.
No lack of outrage over how dialysis patients have become profit centers as opposed to being people though.
-
Rockwell's lead drug candidate Triferic™ is in late-stage clinical development for the treatment of iron replacement in dialysis patients. Triferic™ delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose. Triferic™ has successfully completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). Triferic™ is expected to address an estimated $600M U.S. market
-
Read this. It shows the GRAND PLAN of Rockwell is to see the clinics cut the EPO dose to save money to the clinics. You all could be effected.
Primary Endpoint
The primary objective of the study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery. The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period). Baseline ESA dose was similar between SFP (9448 U/wk) and placebo (9049 U/wk). In the modified ITT population, at the end of the study, ESA dose in the SFP arm was 10557 U/wk and placebo was 13345 U/wk. After adjusting for differences in baseline hemoglobin, the SFP arm required 37.1% less ESA dose compared to placebo. The difference between the two groups was statistically significant (p=0.034). The ESA sparing effect from SFP was observed without an increase in serum ferritin or transferrin saturation. A total of 32 patients received rescue IV iron, 20 in placebo and 12 in SFP. Further analysis of the complete data set is ongoing and the Company plans to submit PRIME data results for presentation at a major medical meeting later in 2013.
Dr. Raymond Pratt, Chief Medical Officer of Rockwell Medical stated, "We are very excited about the results of this well-run study. The 11 microgram/dL SFP dose delivered sufficient iron without increasing iron stores while greatly reducing ESA dose. The safety profile of SFP was similar to placebo and was well tolerated. In this study, a 37% higher ESA dose was needed in the placebo arm to maintain hemoglobin compared to the SFP arm, but in the Phase 3 CRUISE efficacy studies the ESA dose is kept constant, unable to be titrated, over the 12-month study period. The PRIME results support our belief that SFP will demonstrate efficacy in the Phase 3 CRUISE clinical studies by maintaining hemoglobin in the SFP arm while hemoglobin decreases in the placebo arm."
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are extremely pleased with the results of the PRIME study. We believe that SFP's unique ability to treat iron deficiency while dramatically reducing the need for ESA, without increasing iron stores, strengthens SFP's potential to become the market leading iron therapy treatment for CKD-HD patients. SFP's ability to substantially reduce ESA use in the treatment of anemia should translate into significant cost savings in dialysis care while potentially lowering the serious risks associated with the dosing of ESAs. We sincerely thank the study investigators and coordinators, and our clinical team for a well-conducted PRIME study, and we look forward to the upcoming efficacy results from the Phase 3 CRUISE studies, which are expected to read-out in the 2nd-half of this year."
-
I work with numbers all the time being an engineer and know that presenting data you can make anything sound good or bad with the same dataset. Also, phrases like well tolerated are pretty iffy. There is no love with statisticians and engineers. Give me the raw data and let me make my own conclusions. Adjustments and numerical correlations just muddy the waters
-
The "raw data" seems to show AT BEST" they were able to reduce the amount of EPO by a small amount. On the average the patients went from 13,000 units down to 10, 000 units. Woopee. All that money and extra work in the dialysate and thats all they could do? I am NOT inpressed. They staked a lot of money and debt in to this .
-
MORE OURSIDE ANALYSIS ON ROCKWELL MEDICAL AND THEIR DRUG TRIFERIC
What You Need to Know About or Be Warned About Rockwell Medical?
Brean Capital analyst Jonathan Aschoff initiated coverage on Rockwell Medical with a sell plus he commented that:
“Triferic did not appear to reduce total ESA use versus placebo in the PRIME trial, and did not reduce ESA use versus baseline, by contrast to what is seen with IV iron and Zerenex. The CRUISE trials had a questionable design that we view as unlikely to result in approval. Both CRUISE trials did not allow IV iron use or changes in ESA use, which is utterly inconsistent with current dialysis center practice under bundled reimbursement. More than 80% of the patients in all CRUISE arms did not complete the 48-week treatment period, making the primary endpoint evaluation period (defined as the last 1/6 of time on treatment) highly variable among patients. A key employee termination and resulting lawsuit further speaks to inadequate Triferic testing, in our view, where a former VP of Drug Development and Medical Affairs warned Rockwell that its Phase 2b trial did not adequately show efficacy or dose-ranging information to proceed directly to Phase 3."
Sales of Rockwell’s drugs have been stagnant ($60 million, $49 million, and $50 million in 2010, 2011, and 2012, respectively) and we project flat future growth."
A look at Rockwell Medical’s financials does show flat revenues of $49.84M (2012), $48.97M (2011), $59.55M (2010) and $54.73M (2009) for the past four years along with increasingly large net losses of $54.02M (2012), $21.44M (2011), $2.68M (2010) and $5.50M (2009) plus $31.22M in cash and short term investments to cover $18.07M in current liabilities and $19.43M in long term debt. Those financials are something investors should consider but of course FDA approval of Triferic would change all of that (Note: Stifel Nicolaus analyst Annabel Samimy says annual sales of Triferic could reach $200 million a year).