I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: Zach on June 12, 2014, 05:37:40 AM
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http://www.bostonglobe.com/business/2014/06/11/recall-fluid-used-home-dialysis-shocks-worries-patients/kUHgQHt90pw7OHx95PebSJ/story.html
Patients upset after tainted dialysis fluid prompts recall
By Priyanka Dayal McCluskey | GLOBE STAFF JUNE 12, 2014
Angie Caudill stopped drinking soda from cans. She had her tap water tested. She scoured labels on her food and makeup, avoiding products containing one potentially toxic ingredient: aluminum.
And yet the aluminum level in her blood continued to rise. “I did everything they told me to do,” said Caudill, of Harrison, Ohio, “and it kept getting higher and higher.”
Last month, Caudill, who has kidney disease and spent a year on a home dialysis system, learned that a concentrated dialysis fluid she used contained more aluminum that it should have. NxStage Medical Inc. of Lawrence, which sold the fluid, said 140,000 to 150,000 units of the fluid made between April 2013 and February 2014 were involved but declined to estimate how many patients were affected.
On May 15, NxStage voluntarily recalled the fluid, which is used in a home dialysis system it manufactures. The company said it is working with regulators to determine how the problem occurred.
NxStage said there is no evidence that patients were harmed. But the recall has shocked and upset patients, who, because their diseased kidneys can’t clean wastes from blood, rely on NxStage’s products almost daily.
Aluminum, found in many products, including cookware, baking soda, anti-perspirants, and antacids, is generally not harmful. But with high exposure over time, aluminum can build up in the body and cause memory loss, bone disease, and dementia. People without working kidneys are particularly vulnerable because they can’t excrete the metal.
Patients said bad concentrate raised their aluminum levels to two, three, or even four times their normal levels, causing them to feel anemic and sick. No one has sued the company.
“[Patients] are mad that there was no check in place because it’s something people depend on,” said Caudill, who used NxStage’s home dialysis system for a year before her kidney transplant in March. “Their life depends on it.”
Mark Wetzel of Elma, N.Y., who has relied on dialysis on and off for nine years, believes the aluminum made him weak and his mouth dry and metallic-tasting.
“As patients, we’re all under the assumption that there should be quality control,” he said. “Patients right now are very disappointed in NxStage.”
Fewer than 2 percent of the more than 400,000 Americans on dialysis use NxStage’s machines, according to the company. Most patients get treatment at clinics three times a week. Aluminum toxicity was a problem decades ago, when dialysis patients commonly took drugs that contained aluminum, but it is very rare today. Doctors still monitor aluminum levels of people with compromised kidney function.
“If you have chronic exposure, it is a concern,” said Dr. Li-Li Hsiao, director of the Asian Renal Clinic at Brigham and Women’s Hospital.
Founded in 1998, NxStage makes the only portable home dialysis machine on the market. It generated $263 million in revenue last year, but it has yet to make a profit. The company expects to grow as more dialysis patients switch to home treatment, which can be more convenient than going to a clinic.
Patients typically use NxStage’s machine, the System One, about five days a week, for several hours at a time. The recalled product is a clear, electrolyte-packed fluid that is mixed with water and used to flush the waste out of blood.
The concentrate normally contains some aluminum, but it’s unclear whether manufacturing problems, packaging errors, or other causes led to unacceptably high amounts in some batches. Michigan-based Rockwell Medical Inc., which manufactures the concentrate for NxStage, did not respond to a request for comment. NxStage packages the product in Tijuana, Mexico.
NxStage chief executive Jeffrey Burbank said the company changed some procedures after learning of the aluminum problem, but he declined to provide details. “We’re working very hard to make sure this never happens again,” Burbank said.
NxStage didn’t learn of the problem until it was notified in recent months by its customers, including Fresenius Medical Care of Waltham and DaVita HealthCare Partners of Denver, which operate dialysis clinics and manage the care of patients on home dialysis.
“Our surveillance process detected a small rise in serum aluminum levels among patients receiving NxStage therapy,” DaVita spokesman David Tauchen said. “These levels were well below a level that would cause harm.”
Patients are questioning how the aluminum problem went unnoticed by NxStage for more than a year. They said NxStage has done little to restore their faith in the safety of its products.
“What if in the future there’s some sort of manufacturing error and they do not have the proper quality control in place to correct errors before that product goes out to patients?” said Peter Laird, a retired doctor and NxStage patient in Idaho. “What if the next time it’s another component that turns out to be a deadly component?”
Robert Boudrie of Natick said he first learned of the recall on an Internet message board and from his nurse. He received a letter from NxStage a couple weeks later.
“I’m a little bit surprised at how long it took because NxStage is usually responsive,” said Boudrie, an engineer at EMC who has been on dialysis for about two years. “Other than this issue, this little machine they have is the greatest thing since sliced bread.”
NxStage remains the only option for people who want a portable home dialysis machine, said Kevin Ellich, senior research analyst at Piper Jaffray, a Minneapolis investment bank.
He said he doesn’t expect the recall to have much of an effect on NxStage’s earnings.
“If patients really are upset, what would you typically do? Switch to another product,” he said. “But if there’s nobody else, what are you going to do? I can’t imagine NxStage would lose that many customers.”
Priyanka Dayal McCluskey can be reached at priyanka.mccluskey@globe.com. Follow her on Twitter @priyanka_dayal.
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Thanks for posting this Zach.
Priyanka McCluskey clearly did a bit of research for this.
Something new (to me anyway):
Article states that "140,000 to 150,000 units" were recalled, but NxStage declined to state how many patients were involved. Wow, that is a *lot* of SAKS ....... Am I correct that there are around 8,000 of us using NxStage at home? If so, that works out to (140,000 divided by 8,000)=17.5 recalled units per NxStage patient. (assuming a "unit" is one SAK, not a box of as many as 2 SAKs, which would be even higher number))
I checked, I've done over 60 treatments with now-recalled SAKS....so that's over 3 times the average (if all recalled SAKs where distributed evenly (unlikely)). So some of us possibly got lots of recalled product, some none/almost none?
If my math or assumptions are wrong, somebody please correct.
---Dan
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NxStage Medical SVP Sells $129,192 in Stock (NXTM)
Posted by Zach Kirkland on Jun 11th, 2014 // No Comments
NxStage Medical (NASDAQ:NXTM) SVP Winifred L. Swan sold 9,228 shares of the company’s stock in a transaction dated Monday, June 9th. The stock was sold at an average price of $14.00, for a total transaction of $129,192.00. Following the completion of the transaction, the senior vice president now directly owns 21,188 shares in the company, valued at approximately $296,632. The sale was disclosed in a document filed with the Securities & Exchange Commission,
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I suggest all NxStagers on here who have/had problems with aluminum levels and used the bad SAKS contact your local newspapers, send a copy of the Globe article and see if they will do a story on you.
I would also reach out to that reporter and volunteer to share your story with her, priyanka.mccluskey@globe.com. If she had 10+ additional personal stories she might be able to build a second story on the subject.
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I suggest all NxStagers on here who have/had problems with aluminum levels and used the bad SAKS contact your local newspapers, send a copy of the Globe article and see if they will do a story on you.
I would also reach out to that reporter and volunteer to share your story with her, priyanka.mccluskey@globe.com. If she had 10+ additional personal stories she might be able to build a second story on the subject.
Actually, this reporter had MUCH more information provided to her than she chose to address. In fact, she stated to me, thanks for the material but it is more than I can use. I suspect that this is likely her last article she will write on the issue. I don't believe I would interview with her again.
This is a major issue with serious potential consequences but that is not how she reflected. One article I sent her shows that an aluminum exposure in the 1970's from contaminated dialysate led to a 4 times higher accumulated levels in the patients compared to the levels in the contaminated dialysate. This stems from the fact that aluminum is protein bound in patients. This was not reflected in her article nor in any of the NxStage or DaVita statements. They are quick to claim no harm as of yet, but that is for legal purposes much more so than any known outcomes as of yet. Dementia and bone disease show up YEARS after exposure. All affected should be followed for this. However, as one pointed out, how many dialysis patients will live 20 years to develop these issues.
So, not a great article in many ways.
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We all need to do more AAMI tests on dialysate to catch these problems sooner.
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As I had my monthly bloods done, I asked specifically for Aluminium testing. Apparently that's never been done before. ???
So I'll write a letter to the head of Nephro to try to get every D and KD patient regularly tested on those metals, and that the patients know those numbers as well.
That's another disgrace that comes out of this disgrace
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I also know she had a lot of information that she didn't use. Information about aluminum levels and when they started to rise as opposed to when the recall supposedly started. That was a big point discussed elsewhere that patients saw their aluminum levels rise well before the first listed recalled lot number. I think that is another story all on it's own.
During the interviews she was looking for specific information and when more was offered it clearly wasn't going anywhere.
It could have been and needed to be a much different article.
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yep