Leading water expert weighs in on aluminum contamination in dialysate

[slipkid]

I had a sit down conversation with a leading international water expert regarding the contamination of Nxstage dialysate with aluminum.

He said that the technology for getting aluminum levels in water below Nxstage's ten microgram per liter standard is commonly available, and he was stunned that the
dialysate quality is no better than that or worse.

When I said that the dialysate came from Mexico he stated that he WOULD NOT USE ANY PRODUCT USING WATER FROM MEXICO. His opinion was that the source of the water
used in preparing the dialysate was undoubtedly well water, which in Mexico is heavily contaminated with heavy metals among other chemical junk. He joked that anyone
who has vacationed in Mexico and drank the local water knows the intestinal consequences.

So there you have it from a water expert.

As for me, I dumped the Pure Flow system (what a joke!) within days of the recall notice and have switched to hanging the five liter premixed bags. This is but a
stop gap measure precedent to switching to a new dialysis modality as I have absolutely no confidence, now or in the future, in Nxstage and the quality of the
dialysate they provide. I now have to put up with a massive delivery of bags every month, along with the physical struggle to hang over 55 pounds of bags on a badly
designed support pole. I have long felt that what I am now going through invalidates the so-called portability of the system and any substantive advantage Nxstage has
over Fresenius's home 2008K as a therapy delivery system.

With the dialysate recalls of Fresenius, home patients are left swinging in the wind with no place to go for a home therapy system that does not cause injury to themselves,
AND NOBODY WITH THE POWER TO CORRECT THIS SITUATION SEEMS TO CARE, NOR WILL THEY ULTIMATELY DO ANYTHING ABOUT IT.  Note that my complaint is not just
about the Nxstage dialysate recall, but the overall quality of the dialysate even if it meets Nxstage's adherence to ANSI standards. For an understanding of the massive scale
of the problem, see Hemodoc's website and blog posting:  http://www.hemodoc.info/2014/06/nxstage-aluminum-contamination-is-rockwell-medical-at-fault-1.html

Now there are some on this forum -- particularly one person, who claims to be a doctor, and inappropriately asks for personal medical information and gives medical
advice * -- with the utterly naive idea that they can have some effect on getting Nxstage to be a good corporate citizen and clean up its act with regard to
providing an uncontaminated product to persons using its dialysis system.  This is bullshit.  Nxstage will go no further on the contaminate levels of their SAKs
and premixed bags than the ANSI standard on dialysate quality that limits aluminum to a level of ten micrograms per liter.  As my water expert said, this level
is too high for human exposure.

As I said earlier, using the premixed dialysate bags is a stop gap measure for me.  I intend to terminate my use of Nxstage's system as soon as a suitable alternative
such as Baxter's home system, the proposed sorbet systems, or other technologies now being mastered become available. I have been injured by Nxstage and I am mad as hell.

Nxstage is merely another crappy medical company, whose need for profit -- that it claims in its SEC financial filings to have difficulty achieving, that explains
their demonstrated inadequate quality control, and its inability to provide a safe product -- governs its actions.  Moreover, the use of a lactate-based
dialysate -- that Nxstage uses in its system for home patients -- has not been properly evaluated for home hemodialysis.  This fact has been ignored by
nephrologists prescribing the Nxstage dialysis modality.  I have consulted with two neurologists, one with the Cleveland Clinic, who have advised that they
consider the use of lactate dangerous, although they acknowledge that there is little in the way of medical studies to backup their opinions on its use for home
hemodialysis.  Such is the position home dialysis patients are in, dangerous dialysate with no one who cares to do anything about it.

* This person should well consider the HIPPA regulations in soliciting medical information.

[Bill Peckham]

One - HIPPA is of concern to medical providers, entities that have information because they are being paid to provide care, it has no bearing on an individual's right to discuss their care or an individual not being paid to provide care asking about your particular treatment details.

Two - apocryphal statements about Mexico lead me to question the reliability of your expert. If they are an international water quality expert they would be able to discuss the AAMI water standards process in more detail, illuminating why AAMI aluminum levels are what they are

Three - there are lots of good reasons to choose one device over another but the reliability of the supplies and or the dialysate aren't very good ones. Every member of the dialysis industrial complex has provided adulterated and or mis-manufactured supplies, Baxter included. Focusing on the manufacturers lets the providers off the hook - ultimately we are in the position of relying on the providers to give us access to safe and effective care no matter the device - if your provider is just pointing at suppliers with a shrug I'd say that is more of an issue than what ever device you choose to use.

[Hemodoc]

Actrually PiSA is an amazingly good company first started by a Mexican physicians group. Since you did not list who your expert is, I will simply discount his information since PiSA is not the culprit here IN MY OPINION. Although NxStage will not confirm or deny who is at fault in this until the FDA report is finished, I don't believe for one instant that it is PiSA. As I noted in my article, the circumstantial evidence goes back to Rockwell, not PiSA. I mentioned PiSA since there are public SEC records showing  those agreements.

PiSA has an EXCELLENT safety and quality record. Where your "expert" is getting their advice, I have no clue.

As Bill pointed out, HIPPA applies to patient doctor confidentiality, not internet discussions. You can certainly give information on the internet. It happens all the time. I do that often and always advise to research the issues and bring it back for discussion with the medical team. There is nothing wrong with that at all. Patients do this all the time. It is a valid modern day method of dissemination of information. Medical decisions can only be made in the context of a documented doctor/patient relationship. Information is abundant on the internet in many forms.

One fact that you should not overlook is that PiSA is the sole supplier at this time of all the pre-mixed lactate dialysate and there are NO issues of these products. They are not involved in the recall. That is substantial circumstantial evidence that PiSA is not involved in this issue. I cannot find a direct phone number to a public affairs officer of PiSA and the contact system will not go through when I put in a message about NxStage and aluminum. Yet, I still am not convinced or even suspect PiSA in any way.

I would like to be able to go beyond what is publicly available, but I only use information I can confirm on the internet. I searched diligently for any public records that could lead me to who is directly responsible. My opinion is that it is NOT PiSA. We will have to wait until after the FDA concludes their study to confirm or deny this. But upon a thorough review,  I believe Rockwell and Rockwell alone is responsible. I don't believe your information on the Mexican water is reliable at all and I look forward to continued use of an excellent product from PiSA.

[Hemodoc]

One other issue, it is the K/DOQI guideline o f 10 mic/L for aluminum, not a NxStage standard. In reality, if NxStage is correct that the final product was only 11-13 or so, then the tolerances set by the industry, not NxStage are far too high. What they did not take into account is that Aluminum is protein bound in the blood and accumulates 4X or higher than that in the dialysate when measured in the plasma of affected patients.

NxStage will still have the only ultra-pure dialysate. If I can use a lower sodium dialysate from NxStage at a higher volume, then it will be able to compete with the Baxter machine which has an RO system.  I cannot comment on the Fresenius sorbent machine called the PAK because of a nondisclosure agreement, but note it is not yet FDA approved. What issues it has are unknown at present. I am allowed to discuss what is known already on internet sources and they will not have ultra-pure dialysate. They believe it will exceed US and European water standards, but it will not reach the "ultrapure level that NxStage meets.

So when you talk about water standards on a device that has the HIGHEST levels of endotoxin clearance in the entire dialysis industry from PiSA which was the sole provider of concentrated dialysate and pre-mixed dialysate exclusively since 2006, then what information does this so-called expert have about the water quality that PiSA is using? Once again, sources, references and credentials would be a better manner in which to bring this discussion. If he is looking at PiSA, I am thoroughly convinced IN MY OPINION that he is barking up the wrong tree. Just my two cents worth on your contentions from this un-named expert.

[slipkid]

I had a lot of respect for you two men, but I have lost it as I see you ave turned to the dark side.

When a person discloses her personal medical problem on another thread on this forum that Nxstage is making her ill after a period of normalcy, and a forum
participant -- and I will not be obscure anymore, he calls himself Dr. O -- asks her about machine settings
when she is complaining about sky high blood pressure, I get angry.  If what has been suggested by Peckham about HIPAA regarding unknown doctors giving medical
advice on the internet is true -- and I believe it is not and someday a lawsuit will resolve the issue -- then this patient
should have been advised by Dr. O to contact her medical team immediately.  Dr O is completely wrong in playing doctor to a patient
where he has no knowledge of the person's medical history.  I mentioned HIPAA because it states guidelines to protect patient privacy. Dr. O does not understand
its broad sweep of patient protection. He needs to study the regulations on hhs.gov.

I do not accept the propriety of doctors giving medical advice on the internet, particularly anonymously. It can lead
to dangerous medical advice and the patient has little or no legal recourse if he/she follows it and it proves to be wrong.  I find your arguments advanced
here unpersuasive.  The best and only advice that a doctor should give on the internet is to go see a practitioner about your symptoms.

Regarding comments made by my so-called "water expert," my not disclosing his name and the organization he works for was (1) to protect his identity as he was speaking
for himself, and not for his organization, and (2) it would make no difference to you all because minds have been made up about Nxstage's dialysis delivery
system.  The fact that my expert counsels nations around the world about clean water supply and availability and that his qualifications are a matter of record
with these countries is apparently not good enough for you. Moreover, you have dismissed the fact that the SAKs were contaminated above Nxstage's adopted
ANSI/AAMI standard and the SAKs on the recall notice were made in Mexico.  Neither of you have offered any professional qualifications
as to gauging water quality that allows you to question the counsel I was given regarding water quality in Mexico. My conversation was engineer to engineer
and we both have credentials in chemical engineering. I will stick to what I was told about the inadequacy of the ANSI/AAMI standards for safeguarding
dialysis patients and the general state of Mexico's water quality. It is nonsense to discuss contaminate levels on this forum when nearly all participants
have no knowledge of the SI system of units and don't understand a milligram from a micromole. I demand proof from Nxstage of the contaminate levels in the
dialysate THEY SUPPLY no matter who made it, where it was made, or if they they are SAKs or bags. Just as my expert's opinion has been savagely impugned, which is
inappropriate in a scientific debate, I do not accept what Hemodoc has offered about PISA until IT IS DOCUMENTED what the level of contaminates are in the product
they produce. Again I ask, where is the proof?

Hemodoc, your opinion of PISA is nothing less than what I have offered about water quality adequacy from my "un-named expert." Why I am expected to accept unproven
claims by you and Peckham's contemptuous statements displays a conceit that is problematic to any progress being made in patient safety.

The home dialysis system is in crisis mode and only a unified approach of patients demanding a higher quality of care offers ANY hope that the system will be
fixed and improved.  Do Davita and Fresenius give a damn about what modality they offer to patients?  Of course not. It has been demonstrated
that the position of the CEO of Davita is profit first. Patient care is irrelevant.

My comment on Baxter and other companies' proposed systems was a pragmatic approach to patients exploring other options as soon as they are available because
THEIR LIFE IS AT STAKE. What is taking place in home hemo is an offloading of the care of patients from the providers (Davita and Fresenius) to the patient.
Regretfully, from Nxstage's 'point of view, they are involved in this conspiracy to the extent that they have not been able to escape it. Note the unending complaints
on this forum regarding customer (patient) service laid on Nxstage's doorstep. WE ARE NOT CUSTOMERS OF NXSTAGE and should not be making calls to
them at all. Davita and Fresenius should be the only point of contact for any questions on the machine, the dialysate or the therapy being provided.
There is a fundamental switch of liability and costs (the caregiver to the patient, inventory control, etc.) because of the profit motive in using the Nxstage
therapy. If you buy an automobile from a dealer, who is responsible for warranty repair?  The manufacturer of course, but the dealer provides the repairs.
As I said in my original post, home hemo patients are left in a position with neither Davita/Fresenius nor Nxstage wanting to take responsibility for anything. 

Finally, relying on an FDA report of the Nxstage dialysate recall is misguided and misplaced. FDA history is to side with the medical device provider.
Any report, if published, will do nothing to improve the contaminate levels of aluminum or any other metal in the Nxstage dialysate beyond the ANSI/AAMI standards
they follow.  Hemodoc you are wrong, these are the Nxstage standards because they cannot manufacture dialysate to anything less than these specifications.

Nothing has been suggested by either of you two men that advances the state of knowledge of the quality of care now offered by Nxstage or Davita/Fresenius.
I suspect your motives in what you written and will not continue this discussion with such closed minds any further.

[Hemodoc]

Dear slipkid. In what way have I entered the "dark side." Simply because I disagree with your assessment does not make having ulterior motives.

1) Rockwell Medical has the contract for concentrate in the SAKs. PiSA has sole contract on the bags. The bags have not been recalled, the SAKs under contract with Rockwell have even though NxStage and Rockwell will not confirm that this is the source of the aluminum. Look over the NxStage public documents and they spell out those facts clearly. Where Rockwell got it's lactate supply is not known by review of public records.

2) I only write about facts I can confirm with documents or secondary sources. I have not heard a single anonymous or confidential source that implicates PiSA in any manner. I wish I could find some shred of evidence to confirm what is intuitively obvious by the agreements we know NxStage has with both of these companies. Should PiSA in any manner be involved in this mess, I would be incredibly surprised.  What I wrote in my post goes as far as I could with public documents. Note that I asked a question in my title. It remains a question, but in my opinion, Rockwell is the most likely culprit. Until there is direct evidence otherwise, speculating about "well water" in Mexico in my opinion is not helpful.

3) I have no financial connection to NxStage, Rockwell or PiSA.

4) Yes, I do want to see NxStage remain in the marketplace with an untainted product. If they cannot do that, I will jump ship quickly.

5) If unconfirmed allegations that NxStage knew the aluminum levels were elevated a year ago and chose to continue production, likely that is with Rockwell, new to NxStage lactate products, then I fear that would be a fatal step. I don't believe NxStage could remain viable especially once the Baxter Vivia comes to the US market. I don't believe that will be good for the home hemodialysis market and will set us back 10 years. I don't look forward to the demise of NxStage. If that is my ulterior motive, so be it. I admit I still am hopeful NxStage will do the right thing.

Do I believe that Mexican well water from PiSA is what is going on here? No, not even the slightest hint that I can find. If that is what you wish to believe, so be it, but I truly believe that is factually in error.

If you wish to castigate me for disagreeing with you, so be it.

Take care,

Peter

[Speedy1wrc]

All we know for sure right now is that there were SAK's with elevated a!uminum starting in the Spring of 2013. We do know NxStage did sub contract with a vendor. I was told specfifcally that they knew about this a year ago.other than that, everything else is speculation.

[obsidianom]

I wasnt going to enter this argument as I didnt come here to get stressed and argue.  Like the rest of you here I also deal with the ravages of kidney disease in my precious wife. It has changed our lives.  As a result of my wifes medical problems I am responsible for her dialysis, 20 hours per week, her feeding tube every night, all the house work , cutting down trees and cutting them up for firewood to heat our house, running a medical practice still part time and having more of a load on me as my wife was my prime employee for many years and can do less of it now with her kidney disease. To make a long story short, I am very busy and stressed by life and dont really have any desire to be harrassed here. This is my volunteering my knowledge to try to help others, PERIOD.

Now as to my credentials,----. All I will say is I wont go there. I dont care if you beleive I am a doctor or the King Of England or a garbage collector or an unemployed bum with a computer.  . I stay anonymous and prefer to stay that way. In esssence I am just an anonymous poster who "claims " to be a doctor. That way no one should ever use anything I write as gospel. I am simply with an internet name giving information that you can take or not. Since I am not treating anyone here, just discussing medical information I am not required to prove anything about myself nor should anyone use me as their "voice" in any treatment decisions. I do beleive I generally have useful information to offer that may help improve someones life. You and anyone else can listen or ignore it.

What I dont understand is the vitriol thrwon at me here. I came here from a very busy life to give my time for NO RENUMERATION . I am here to help. Nothing more. Now whether you agree with what I write or not, personally attacking me is not what this site is about. If you dont like what I write , IGNORE it. I dont attack people here. I beleive I have helpled a lot of people here .   I have the right to free speech , the same as anyone.

Now as to HIIPA.  There is no confidentiality on the internet. There is no doctor -patient relationship. I simply ask questions . If someone chooses to give out their personal medical info , that is their right. In fact a patient can publish their own entire medical record on the internet if they choose.  Anyone can then comment on it.      I never divulge anything given to me in private. I deal with HIIPA everyday in my office and have for many years. I dont need to be educated on it.     On the post you criticized, I simply asked for more information as the person wanted help. I am not in any way trying to treat them. I did find an issue with the dialysate volume and said so. I also advised they go to their team to deal with it . If that helps I am gratified. If not , at least I tried to help someone who is in need of help.

You are angry at Nxstage, I understand that. I am too. My wifes aluminum is 44 . I am not happy about that. But turning on me with the anger is misdirected. I didnt cause this mess. My wife and I are victims too. 

So all I ask is to stop personal attacks on me for my efforts to help.  Now I have to go back to being my next role of Sultan of -----.

[Speedy1wrc]

Well put. This after all is a support group.