Dialysis from the sharp end of the needle

Baxter sues Fresenius over four new patents

On Monday 4/28/08 in Chicago, Baxter filed a new lawsuit against Fresenius Medical Care Holdings AG in U.S. District Court. The suit again involves Fresenius' 2008K dialysis machine. Baxter alleges that the Fresenius 2008K dialysis machine infringes on four US patents: patent number 7,264,730; patent number 7,303,680; patent number 7,318,892; patent number 7,351,340.

Baxter won a recent court decision on four different patents. These latest four patents in dispute, were all approved in the last year From ip.law360.com (registration required).

United States patent number 7,264,730
Abstract: A number of improvements relating to methods and apparatuses for kidney dialysis are disclosed. These include methods such as supplying a dialysis machine including a touch screen interface to a machine user and supplying to the machine user accessory devices to be used with the dialysis machine in operation.

United States patent number 7,303,680 and patent number 7,318,892
Abstract: A number of improvements relating to methods and apparatuses for kidney dialysis are disclosed. These include checking of dialysate bypass status using flow measurement; using a flow sensor to confirm the absence of ultrafiltration during bypass; automatic testing of ultrafiltration function by removal of a discrete volume from a portion of the dialysate flow path coupled with a pressure test of that part of the flow path; using a touch screen user interface; bar graph profile programming of ultrafiltration, sodium, and bicarbonate parameters; using a RAM card to upload treatment instructions to, and to download treatment data from, the machine; automatic setting of proportioning mode (acetate or bicarbonate) based on connections of concentrate lines; predicting dialysate conductivity values based on brand and formulation of concentrates; minimizing no-flow dead time between dialysate pulses; initiating operation in a timed mode from a machine power-off condition; preserving machine mode during machine power-fail condition; calibration scheduling and reminding; automatic level adjusting; and blood leak flow rate detecting

United States  patent number 7,351,340
Abstract: A number of improvements relating to methods and apparatuses for kidney dialysis are disclosed. These include a method providing an apparatus for dialyzing to a consumer, with the apparatus including a controller for controlling a dialysate parameter, a delivery system for delivering the dialysate to a dialysate compartment of a dialyzer, and a user/machine interface having a touch screen to display an indicium corresponding to a parameter pertinent to operation of the apparatus for use in dialysis and to enable a user though touching the indicium to effect a change in the parameter. The method also includes providing supplies that are useable with the apparatus to the consumer.

Baxter seems to be intent on ratcheting up the pressure on FMC by seeking a second permanent injunction to prevent FMC from profiting from/selling their K machine, as it is currently designed. Apparently FMC could redesign certain features to avoid infringing - in announcing their intention to appeal the decision earlier this month FMC said "it has developed a back up design and expects no material impact on its product business". It is not clear what would have to happen for FMC to institute the alternate design(s).

 

RSN Takes the Renal Teen Prom to Washington, D.C.

The Renal Support Network has had a renal Teen Prom in the LA area for nine years. On May 10th they will host their first Renal Teen Prom on the East Coast:

The East Coast Renal Teen Prom will be held at DeMatha High School in Hyattsville, Maryland, about fifteen minutes by car from Capitol Hill. The event, themed “Dancing Under the Stars,” is for teens ages 14 to 24 who have chronic kidney disease and a guest of their choice. The prom attendees will be treated to dancing and limo rides, dinner and appetizers, glamour photos and a DJ. Some transportation will be available with volunteer drivers from the area. ...
For further information and to receive an invitation, contact RSN at www.RSNhope.org or toll-free (866) 903-1728. 

This is a great event if you live in the area or can get to Washington for next weekends' prom.

More information trickles out about Lufkin, TX dialysis unit

KTRE.com quotes family members of a Lufkin DaVita dialysis patient:

Family members are awaiting a copy of the death certificate. They tell us doctors told them Opal Few died of a weakened heart caused by blood loss. Opal is one of several patients who have died unexpectedly within the last month at the DaVita Dialysis center in Lufkin. Other patients suffered serious complications.

Exsanguination - blood loss - can happen quickly at high incenter blood pump speeds, however usually it is a one off event - something more seems to be at work at the Lufkin unit. This Lufkin Daily News account includes the case of another Lufkin patient who stopped breathing while dialyzing on April 1st, while the incident reported by KTRE happened on Saturday April 26th.

The comment thread to the Lufkin Daily News article continues to grow with posts from people identifying themselves as family members of patients and staff. Many of the posts seem very heartfelt and may reveal how the story will develop but as with all anonymous internet post these should be read with some healthy skepticism.

NKC Breakfast of Hope - May 22nd

Northwest Kidney Centers is proud to announce the 6th Annual Breakfast of Hope featuring celebrated international chef and author Graham Kerr.  Know for many years as the Galloping Gourmet, Mr. Kerr's focus is on helping people make healthy, creative, lifestyle changes and believes that the only lasing changes are the ones that we enjoy.

Graham will share his personal stories, and how to create a satisfying, healthy diet by converting "habits that harm into resources that heal."

What:  Northwest Kidney Centers 2008 Breakfast of Hope

When:  Thursday, May 22, 2008

Time:  7:30 a.m. – 8:45 a.m.

Where: Westin Hotel, Grand Ballroom

Suggested Donation: $150

The Breakfast of Hope raises funds to support the life-sustaining dialysis care and patient-focused support services provided by the Northwest Kidney Centers.

This is going to be a great event; drop me an email if you'd like to go. If you can't attend you can still donate; designate your donation as I do, for kidney research and help NKC build a kidney research institute. Now.

Comments shed light on Lufkin dialysis unit closure

News of a sudden dialysis unit closure in Texas came out yesterday. RenalWEB linked to a report from KTRE.com but details remained sketchy. A Lufkin Daily News account quotes DaVita spokeswoman Stephanie Horn via press release "Right now, it would irresponsible to speculate beyond the facts we have and we will remain focused on our patients and the care they need" but what event(s) led to the closure is not mentioned.

The Lufkin Daily News article allows comments; one comment seems to be from a family member who indicates three patients died during treatment, which would be a highly unusual event and would explain the sudden closure.

Congressional testimony about heparin sabotage

RenalWEB links to a Reuters story on Congressional testimony concerning the contaminated heparin that caused nearly 100 deaths among people on dialysis. Families of the people who died testified, as did "Baxter Chief Executive Robert Parkinson who said it seemed the heparin contaminant, over-sulfated chondroitin sulfate, was deliberately added to the drug."

Adding a contaminate to an injectable medication would, I believe, constitute at least manslaughter, if not homicide, without knowing the motives of the saboteur it is hard to know the crime.

Rep. Bart Stupak, a Michigan Democrat, said it was still uncertain whether the contamination was intentional or accidental. He said both companies should have done more to assure their products were safe.

"Both Baxter and SPL have failed the American public," said Stupak, chairman of the U.S. House of Representatives Energy and Commerce Committee's oversight and investigations subcommittee.

I don't think this is right. The saboteur chose oversulfated chondroitin sulfate as the contaminate because it would get through the safeguards. I think this is a warning that there are people who will purposely circumvent safeguards to increase profits. I don't think our current screening is designed to ferret out bad actors - we seem to be giving producers in China and elsewhere too much credit. It may be that Baxter and SPL were too trusting but that seems to be a standard business practice these days:

Last year saw a string of U.S. recalls linked to China, ranging from contaminated pet food and toothpaste, to excessive lead in paint that saw millions of toys swept from stores.

We need a new approach to product safety, one that relies less on trust and more on hard data.

KCP applauds NTU

RenalWEB links to a press release from Kidney Care Partners that applauds the National Taxpayers Union for their misguided stand on MSP.

Kidney Health Fest for African American Families

"Treat the Kidney to Save the Heart"

When: Saturday, May 3, 2008 (This Weekend!)

Where: African American Academy 8311 Beacon Ave. S., Seattle, WA

Time: 9:00 a.m. to 1:30 p.m.

FREE  Admission, FREE Lunch, FREE Health Screenings

• Celebrity Speaker and Guests
• Prizes
• Music and Entertainment
• Cooking Demonstrations
• Cooking Classes For Kids
• Healthy Soul Food Recipe Contest
• Booths & Exhibits
• Kids Korner

Sponsorship opportunities are available. For more information on this event, please contact Ingrid Goodwin at ingrid@nwkidney.org< or call (206) 292-2771, ext. 5357.

This event has grown each year. Be a part of a great event stop by this Saturday.

Dialysis and CKD Blog Report April 28

Dialysis is in addition to everything else and everything else can be plenty -

• The life of a 20-something with Lupus x-ray inconclusive, YouTube video features several of her doctors
• Drinking my way through Trader Joe's wine likes a Spanish wine, wants another bottle
• Kaply Inc. because she loves you she'll only kill you for your own good; makes it to dialysis (5:30AM?)
  
• On the road to a cure lists upcoming Lupus Walks for May, awards gala May 7, research newsletter available
• I am. Are you? continues drive for organ donation; debunks donation myth, with video
  
• Toastiest political coverage; gets play list organized
• Jack's kidney adventure remembers Arbor Day and that the 11th marked 2 years on the sharp end of the needle
  
• Kamal Shah a poem - remember to slow down
• Eating well on dialysis gives a recipe for a summer classic: Cole Slaw
• Writings on the cave wall works a full shift
• KCER post the Atlantic storm season forecast (will we be lucky a second year? I wouldn't count on it)
• Strnad family digest is working towards transplant - five potential donors ready to be tested
• Daily dialysis (translated from Spanish) parathyroid operation scheduled for May 6th, gets room painted - looses monitor in process
• Really I'm as old as I feel waited all weekend for call to find out he needs to redo missing lab tests
• Chronic positivity keeps up the self cannulation, has procedure scheduled; hearing people remark on how slow time is passing does not help to pass the time
• Stacy without an e: women!? (I think there's a Sinatra song in there)
• Tasty kidney pie offers some creative writing; remarks on traveling with NxStage, shows air travel case; links to petition
• The truth about dialysis for patients gives home dialysis newsletter update
• My lazy kidneys sees some positive trends feels hopeful about third trimester
• Stayin' alive looses preferred dialysis shift, will shift to less work compatible shift (cough, home dialysis, cough, cough)
• Kidney diet tips has some good tips on identifying potassium in foods (new URL)
• Kindey Postings talks fast food (new URL)
• My kidney blog has some technical problems but it's real life that is her focus as she trys to cope with a sudden loss
• PKD pugilist loses a friend
• My wife has lupus answers comment with a post sharing work life balance tricks when a spouse is sick
• The lupus living room posts on lupus and hormone replacement therapy
• The dialysis diary looks for his dry weight; shuffles schedule to get some solid sleep
• As the pump turns needs stethoscope; notes warm temperatures; gets skin art
• Kevin's blog had a rough week, decides on peritoneal dialysis
  

NTU thinks extending Dialysis's Medicare Secondary Payer provision is a good idea

The National Taxpayer Union (NTU) has come out with a position statement on the Medicare Secondary Payer provision of the US dialysis program. In NTU's letter to the Senate Finance Committee NTU's Pete Sepp, Vice President for Policy and Communications, comes out in favor of extending the MSP to 60 months. I've blogged about the MSP provision before: giving MSP's legislative history, the current administration's MSP extension proposal contained in the 2009 budget, and I've outlined how Medicare pays for dialysis, putting the MSP provision in context.

Forced to switch to Medicare?

The NTU letter is long and convoluted but the gist is that they can't understand why people on dialysis are "forced to switch to Medicare as their primary provider after 30 months of treatment" (actually its 33 months of treatment incenter because of the three month initial waiting period). First it isn't that people are forced to switch to Medicare - it's that they get to switch to Medicare.

NTU continues, "Apparently this strange process is a relic of a time when private facilities for dialysis, and private coverage of their services, was thought to be inadequate." Um yeah, most people think that having people go before a committee to decide whether they could continue to live constitutes inadequate coverage. The US dialysis program under Medicare exists so that people don't die of a treatable condition. Dialysis is unique - it's like a switch - with it you live, without it you die. If there was not a dialysis entitlement those with severe kidney disease and without insurance, would be forced into emergency rooms a couple times a week to receive life extending treatment, an even greater burden to taxpayers.

Someone's understanding of the numbers is off

As uninformative as that is, the letter really goes off the tracks when it gets to numbers. NTU acknowledges the opposition of large employers to extending MSP but is puzzled:

Like many other proposed changes to Medicare that should be non-controversial, supporters of the current ESRD policy doggedly cling to fearful predictions of chaos if this burden to taxpayers is lightened. One common assertion is that extending the 30-month coverage period would amount to a "cost shift" that would severely disrupt private employers' insurance plans. General Motors, for example, attests that extending primary payer coverage for ESRD by 12 months (to 42 months total) would increase their insurance costs.
...
Here again, words can be deceiving. According to U.S. Renal Disease System statistics cited in an analysis by Kidney Care Partners, the average dialysis patient cost amounts to $180,000 per year. By that standard, GM's estimate would have to assume an average cost of four times that amount, for an average number of patients 2-1/2 times greater than those typically found in the general population.

Medicare's cost (their 80% share of the allowed charges) for someone on dialysis and not in a skilled nursing facility is about $55,000/year. Of that about $24,000 is for Part B outpatient dialysis services. You can back into how many people are thought would be impacted from the projected savings NTU cites: "[extending MSP to 60 months would] save Medicare $1.02 billion over five years and $3.07 billion over 10 years" or about 41,000 patient years of coverage over five years.

I believe, though NTU's letter is not clear about this, that "the average dialysis patient cost amounts to $180,000 per year" is the average Part B costs of someone on dialysis to a private insurance plan. The  costs to private payers of extending the private pay period to 60 months would be over $7,000,000,000. And that's using the $180,000 yearly cost which implies a per treatment rate of about $600 for dialysis and $500 for separately billable services (e.g. medications, labs). Another data point to keep in mind are the dialysis charges reveled in a recent court filling of $2,900 per dialysis treatment and $9,000 total charges per visit. However, acknowledging these number would be a problem for NTU's analysis.

NTU does grant that "insurance choice is limited, and we support legislation to provide more options for Americans. Yet the fact remains that consumers, employers, and small businesses have at least a few voluntary options for seeking and negotiating health care coverage." However, NTU does not mention recent legislative efforts at the state level to circumvent the imagined negotiation process. You would think an organization called the National Taxpayer Union would be better with numbers.

Don't decrease support of the US dialysis program

NTU does not care about the provision of dialysis or the people on dialysis beyond the financial costs of the program. They see extending the MSP as a good in and of itself, rather than as a bitter compromise to pay for desperately needed improvements to the federal dialysis program. An extension to 42 months is barley acceptable if it allows a mechanism to routinely adjust dialysis reimbursement for inflation; funds community outreach and screening; funds pre-dialysis education for individuals with kidney disease to help slow progression of CKD; and provides enhanced training for caregivers (sign the petition). Extending MSP to 60 months should not be on the table.

NTU is advocating for a cut to the US dialysis program, and an effective end to a federal program that for 35 years has meant people with severe kidney disease can have confidence that they will have access to routine treatment. NTU is giving the Senate Finance Committee bad advice.

"You're gonna need a bigger boat" says Institute of Medicine

CIDRAP has an article up on a new IOM report on antiviral use during a pandemic.The IOM report Antivirals for Pandemic Influenza; Guidance on Developing a Distribution and Dispensing Program comes up with 13 recommondations; recommendation 2.1  notes that the Department of Homeland Security is considering using prophylactic doses of antivirals only in the initial containment phase and certain "highly select circumstances", while the Department of Health and Human Services recommends a wider use of prophylactic antivirals.

I think people will want prophylactic doses of antivirals. One obvious problem with stockpiling single treatment doses is that in an actual event when to use this single bullet will be a hugely difficult decision. People are going to want prophylactic doses. Anyone with close contact with the public is going to want personal protective equipment and a daily dose of Tamiflu. The federal government should have a single recommendation and it should be to encourage the stockpiling of antivirals in the quantity that would allow prophylactic use.

In Jaws when Sheriff Brody tells Quint that they'll need a bigger boat, he has caught his first glimpse of the movie's namesake fish. No one has seen what the next pandemic looks like but when they do I think they'll want a bigger boat - they'll want to take Tamiflu everyday.

Dialysis & CKD discussion board report for 4/27

Dialysis & CKD discussion boards activity this week from 4/20 to 4/27. IHD stays above the 2,000 mark and Kidney Fun stays above a 1,000, while Kidney Space settles into the three position.

1. I Hate Dialysis 2,218 new posts; 115 new threads; 1,865(+22) members
2. Kidney Fun 1,277 new posts; n/a; 363(+11) members
3. Kidney Space 232 new posts; 16 new threads; 349(+11) members
4. Kidney Friends 181 new posts; 26 new threads; 232(+2) members
5. Davita 157 new posts; 16 new threads; 6,046(+32) members
6. The Kidney Patient Guide 104 new posts; 14 new threads; 1,500(+6) members
7. Angie's Kidney Community 98 new posts; -11 new threads; 189() members
8. Home Dialysis Central Forums 38 new posts; 4 new threads; 442(+1) members
9. Care Giver Talk 20 new posts; 1 new thread; 217() members
10. Renal Romance 13 new posts; 5 new threads; 148(+53) members
11. Global Dialysis 12 new posts; 0 new threads; 395(+5) members
12. Life Options 1 new post; 0 new threads; 251(+1) members

• Other dialysis/CKD discussion boards (data not published)
  
  • JENY ESRD Network Community
  • Nephrology Now registration required
  • Kidney Research UK
  • RenalWeb
  • Talkline
  • Dialysis & Transplant City
  • Lupus Foundation of America

If you know of an active discussion board covering CKD related subjects leave a comment or send an email with the URL and I'll add it to the discussion board report.

Dialysis & CKD discussion boards activity this week from 4/20 to 4/27. IHD stays above the 2,000 mark and Kidney Fun stays above a 1,000, while Kidney Space settles into the three position.

1. I Hate Dialysis 2,218 new posts; 115 new threads; 1,865(+22) members
2. Kidney Fun 1,277 new posts; n/a; 363(+11) members
3. Kidney Space 232 new posts; 16 new threads; 349(+11) members
4. Kidney Friends 181 new posts; 26 new threads; 232(+2) members
5. Davita 157 new posts; 16 new threads; 6,046(+32) members
6. The Kidney Patient Guide 104 new posts; 14 new threads; 1,500(+6) members
7. Angie's Kidney Community 98 new posts; -11 new threads; 189() members
8. Home Dialysis Central Forums 38 new posts; 4 new threads; 442(+1) members
9. Care Giver Talk 20 new posts; 1 new thread; 217() members
10. Renal Romance 13 new posts; 5 new threads; 148(+53) members
11. Global Dialysis 12 new posts; 0 new threads; 395(+5) members
12. Life Options 1 new post; 0 new threads; 251(+1) members

• Other dialysis/CKD discussion boards (data not published)
  
  • JENY ESRD Network Community
  • Nephrology Now registration required
  • Kidney Research UK
  • RenalWeb
  • Talkline
  • Dialysis & Transplant City
  • Lupus Foundation of America

If you know of an active discussion board covering CKD related subjects leave a comment or send an email with the URL and I'll add it to the discussion board report.

Dialysis & CKD discussion boards activity this week from 4/20 to 4/27. IHD stays above the 2,000 mark and Kidney Fun stays above a 1,000, while Kidney Space settles into the three position.

1. I Hate Dialysis 2,218 new posts; 115 new threads; 1,865(+22) members
2. Kidney Fun 1,277 new posts; n/a; 363(+11) members
3. Kidney Space 232 new posts; 16 new threads; 349(+11) members
4. Kidney Friends 181 new posts; 26 new threads; 232(+2) members
5. Davita 157 new posts; 16 new threads; 6,046(+32) members
6. The Kidney Patient Guide 104 new posts; 14 new threads; 1,500(+6) members
7. Angie's Kidney Community 98 new posts; -11 new threads; 189() members
8. Home Dialysis Central Forums 38 new posts; 4 new threads; 442(+1) members
9. Care Giver Talk 20 new posts; 1 new thread; 217() members
10. Renal Romance 13 new posts; 5 new threads; 148(+53) members
11. Global Dialysis 12 new posts; 0 new threads; 395(+5) members
12. Life Options 1 new post; 0 new threads; 251(+1) members

• Other dialysis/CKD discussion boards (data not published)
  
  • JENY ESRD Network Community
  • Nephrology Now registration required
  • Kidney Research UK
  • RenalWeb
  • Talkline
  • Dialysis & Transplant City
  • Lupus Foundation of America

If you know of an active discussion board covering CKD related subjects leave a comment or send an email with the URL and I'll add it to the discussion board report.

Dialysis & CKD discussion boards activity this week from 4/20 to 4/27. IHD stays above the 2,000 mark and Kidney Fun stays above a 1,000, while Kidney Space settles into the three position.

1. I Hate Dialysis 2,218 new posts; 115 new threads; 1,865(+22) members
2. Kidney Fun 1,277 new posts; n/a; 363(+11) members
3. Kidney Space 232 new posts; 16 new threads; 349(+11) members
4. Kidney Friends 181 new posts; 26 new threads; 232(+2) members
5. Davita 157 new posts; 16 new threads; 6,046(+32) members
6. The Kidney Patient Guide 104 new posts; 14 new threads; 1,500(+6) members
7. Angie's Kidney Community 98 new posts; -11 new threads; 189() members
8. Home Dialysis Central Forums 38 new posts; 4 new threads; 442(+1) members
9. Care Giver Talk 20 new posts; 1 new thread; 217() members
10. Renal Romance 13 new posts; 5 new threads; 148(+53) members
11. Global Dialysis 12 new posts; 0 new threads; 395(+5) members
12. Life Options 1 new post; 0 new threads; 251(+1) members

• Other dialysis/CKD discussion boards (data not published)
  
  • JENY ESRD Network Community
  • Nephrology Now registration required
  • Kidney Research UK
  • RenalWeb
  • Talkline
  • Dialysis & Transplant City
  • Lupus Foundation of America

If you know of an active discussion board covering CKD related subjects leave a comment or send an email with the URL and I'll add it to the discussion board report.

Dialysis & CKD discussion boards activity this week from 4/20 to 4/27. IHD stays above the 2,000 mark and Kidney Fun stays above a 1,000, while Kidney Space settles into the three position.

1. I Hate Dialysis 2,218 new posts; 115 new threads; 1,865(+22) members
2. Kidney Fun 1,277 new posts; n/a; 363(+11) members
3. Kidney Space 232 new posts; 16 new threads; 349(+11) members
4. Kidney Friends 181 new posts; 26 new threads; 232(+2) members
5. Davita 157 new posts; 16 new threads; 6,046(+32) members
6. The Kidney Patient Guide 104 new posts; 14 new threads; 1,500(+6) members
7. Angie's Kidney Community 98 new posts; -11 new threads; 189() members
8. Home Dialysis Central Forums 38 new posts; 4 new threads; 442(+1) members
9. Care Giver Talk 20 new posts; 1 new thread; 217() members
10. Renal Romance 13 new posts; 5 new threads; 148(+53) members
11. Global Dialysis 12 new posts; 0 new threads; 395(+5) members
12. Life Options 1 new post; 0 new threads; 251(+1) members

• Other dialysis/CKD discussion boards (data not published)
  
  • JENY ESRD Network Community
  • Nephrology Now registration required
  • Kidney Research UK
  • RenalWeb
  • Talkline
  • Dialysis & Transplant City
  • Lupus Foundation of America

If you know of an active discussion board covering CKD related subjects leave a comment or send an email with the URL and I'll add it to the discussion board report.

Dialysis & CKD discussion boards activity this week from 4/20 to 4/27. IHD stays above the 2,000 mark and Kidney Fun stays above a 1,000, while Kidney Space settles into the three position.

1. I Hate Dialysis 2,218 new posts; 115 new threads; 1,865(+22) members
2. Kidney Fun 1,277 new posts; n/a; 363(+11) members
3. Kidney Space 232 new posts; 16 new threads; 349(+11) members
4. Kidney Friends 181 new posts; 26 new threads; 232(+2) members
5. Davita 157 new posts; 16 new threads; 6,046(+32) members
6. The Kidney Patient Guide 104 new posts; 14 new threads; 1,500(+6) members
7. Angie's Kidney Community 98 new posts; -11 new threads; 189() members
8. Home Dialysis Central Forums 38 new posts; 4 new threads; 442(+1) members
9. Care Giver Talk 20 new posts; 1 new thread; 217() members
10. Renal Romance 13 new posts; 5 new threads; 148(+53) members
11. Global Dialysis 12 new posts; 0 new threads; 395(+5) members
12. Life Options 1 new post; 0 new threads; 251(+1) members

• Other dialysis/CKD discussion boards (data not published)
  
  • JENY ESRD Network Community
  • Nephrology Now registration required
  • Kidney Research UK
  • RenalWeb
  • Talkline
  • Dialysis & Transplant City
  • Lupus Foundation of America

If you know of an active discussion board covering CKD related subjects leave a comment or send an email with the URL and I'll add it to the discussion board report.

Dialysis & CKD discussion boards activity this week from 4/20 to 4/27. IHD stays above the 2,000 mark and Kidney Fun stays above a 1,000, while Kidney Space settles into the three position.

1. I Hate Dialysis 2,218 new posts; 115 new threads; 1,865(+22) members
2. Kidney Fun 1,277 new posts; n/a; 363(+11) members
3. Kidney Space 232 new posts; 16 new threads; 349(+11) members
4. Kidney Friends 181 new posts; 26 new threads; 232(+2) members
5. Davita 157 new posts; 16 new threads; 6,046(+32) members
6. The Kidney Patient Guide 104 new posts; 14 new threads; 1,500(+6) members
7. Angie's Kidney Community 98 new posts; -11 new threads; 189() members
8. Home Dialysis Central Forums 38 new posts; 4 new threads; 442(+1) members
9. Care Giver Talk 20 new posts; 1 new thread; 217() members
10. Renal Romance 13 new posts; 5 new threads; 148(+53) members
11. Global Dialysis 12 new posts; 0 new threads; 395(+5) members
12. Life Options 1 new post; 0 new threads; 251(+1) members

• Other dialysis/CKD discussion boards (data not published)
  
  • JENY ESRD Network Community
  • Nephrology Now registration required
  • Kidney Research UK
  • RenalWeb
  • Talkline
  • Dialysis & Transplant City
  • Lupus Foundation of America

If you know of an active discussion board covering CKD related subjects leave a comment or send an email with the URL and I'll add it to the discussion board report.

Dialysis & CKD listserv report 4/27

If you need information or support about: dialysis (hemodialysis and peritoneal dialysis; incenter hemodialysis or home dialysis); or kidney transplant; or how to slow kidney disease - look into joining a listserv. Not only is the day to day conversation helpful the archives are a wealth of information - join the conversations (these are all listservs hosted by Yahoo Groups see the Yahoo groups help page for any who, how or when questions about listservs).

This week dialysis-support jumped into the 3rd most active slot and added the most members with 16 people joining the discussion:

1. iga-nephropathy 166 messages to 2,936(+11) members
   
2. kidney_transplants 128 messages to 1,057(+15) members
3. dialysis-support MM 109 messages to 133(+16) members
4. Kidney/Pancreas Transplant Recipients 44 messages to 285(-2) members
5. EndStageRenalDisease 41 new messages to 397(-1) members
6. NxStage_Users M 39 messages to 44() members
7. renalrelating 35 messages to 154(+4) members
8. PKDCARE 32 messages to 662(+7) members
9. kidneykidneydisease 22 messages to 314(-2) members
10. Autosomal Recessive Polycystic Kidney Disease 21 messages to 319(-1) members
11. Australian_Dialysis_Buddies 13 Messages to 57() member
12. A_dialysis_and_support_group 6 message to 35() members
13. NxStageUsersGroup M 2 Message to 79() members

(An 'M' indicates I am a member; 'MM' indicates I am a member and a moderator; criteria for membership is set by list owner; posts in the last seven days; members change in the last seven days; let me know if you have an active group not on the list; .

CKD links and resources

• Main Link Page
• Dialysis and CKD Blogs
• Dialysis and CKD Discussion Boards
• Dialysis and CKD Listservs

CKD Knowledge Advocacy Groups CKD Shopping Information/News Knowledge Resources Medical Journals Recipes and Nutrition Information Renal Industry Blogs

The CKD Players Professional Organizations Research Dialysis Equipment Manufacturers ESRD Networks For profit Dialysis Providers Nonprofit Dialysis Providers US Government

New links added on Sunday April 27th

Professional Organizations

• International Society for Hemodialysis
  • Quotidian Dialysis Registry

CKD Shopping

• Care Wear
• Kidney Fun Mall
• My Kidney Gear

Baxter CEO Town Hall meeting on heparin contamination

The Chicago Tribune is reporting on a Town Hall meeting Baxter Chairman and Chief Executive Bob Parkinson had on the 23rd:

His [Parkinson] 9-minute "town hall meeting'' with employees was almost solely focused on heparin, a product sold in vials that generates about $30 million of the company's more than $11 billion in annual sales.

So heparin accounts for less than a third of one percent of sales but it is an important medication:

Parkinson said Baxter is providing more than 6 million injections or infusions a day to patients "far and away more than any other company in the world.'' He added, "every product we sell...is the difference between life and death.''

Compare his acknowledgment of their duty with the finger pointing and blame shifting of the Chinese delegation on Monday.

Parkinson said Baxter's inspection process, which has since been intensified, would not have been able to detect the heparin-like substance he said appears now to have been put into the supply chain by an "unscrupulous character" motivated by profit.

The FDA, Baxter and other companies are now using new MRI-like detection technology and other high-tech methods to examine heparin products at the border.

All products coming from China should be subject to intensified inspections. (note that  there is video posted on the Baxter website but I could not get the video to work)

Managing prescriptions to avoid medication errors

Kidney Times has a thorough look a how to avoid medication errors. Medication Reconciliation: A Practical Guide For Dialysis and Transplant Patients by By Matt Schonder, RPh, MBA, and Kristine S. Schonder, PharmD- two pharmacy experts - gives an overview of what hospitals and pharmacists are doing to prevent errors but when all is said an done the authors suggest you make tracking your own prescriptions a top priority. Unfortunately this is not a one time thing since medications change this requires on going effort but it is a job we have to do.

Shutting down NAMRU2 just a symptom of a larger problem

Bingo, a commenter to the article about Indonesia shutting down NAMRU2, contends it is Indonesia who is aggrieved. They may feel that way but still, shutting down NAMRU2's operation is not helpful to anyone. It dangerous for Indonesia and for the world. Everyone, everywhere is at risk from infectious diseases, microbes don't respect international boarders. CIDRAP has a number of helpful articles available to give this decision context Indonesia denies seeking payment for virus samples, HHS official reports on Southeast Asia issues, HHS secretary blogs on impasse with Indonesia, and the Secertary of DHHS Mike Leavitt's Apr 17 blog post.

It's Indonesia that has linked virus sharing and NAMRU2 - for additional context on the ongoing virus sharing dispute see this CIDRAP News story "Virus-sharing pact eludes WHO group, but work will continue" from November 26, 2007.

CIDRAP reported on Wednesday that:

The US Embassy in Jakarta yesterday denied recent allegations in a book by [Indonesian Health Minister Siti Fadilah] Supari that the United States intends to make biological weapons out of avian influenza viruses, the Jakarta Post reported today.    

A press release from the US Embassy said Supari's claims "are preposterous and a grave injustice to the people of the United States," the Post reported.    

The embassy statement also said the United States is committed to working with other countries and international groups to halt the spread of avian flu, prevent a pandemic, and plan for pandemic-related health emergencies, according to the Post.    

In February, Supari published a 182-page book, Time for the World to Change: God is Behind the Avian Influenza Virus, that included the claims about the United States, as well as allegations that the WHO was conspiring to profit from H5N1 vaccines.

Indonesian President Susilo Bambang Yudhoyono wrote a foreword to the book but later ordered Supari to recall copies of it, according to previous media reports. However, he has said he supports Supari's calls for equitable international virus-sharing policies.

Indonesia is playing a dangerous game. We need more information about what the virus is doing not less. We need not only blood samples from people who show symptoms of H5N1 infection but also of the general population and other mammals - both domesticated (cats, dogs, pigs) and wild (bats, cats, rodents). The fundamental problem is a lack of trust and in that Bingo is probably right that US international policies have not helped.

               

MIT to China: You don't know what you're talking about

RenalWEB links to a report from the Massachusetts Institute of Technology (MIT) refuting the weak excuses a delegation from China offered at a news conference on Monday concerning the contaminated heparin ingredients a Chinese producer supplied to heparin suppliers around the world. Presumably Chinese spokesperson Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products is flying home in disgrace after offering only finger pointing and blame shifting, instead of apologies on Monday.

The MIT teams led by Professor Ram Sasisekharan of MIT figured out how to test for the Chinese contaminant - oversulfated chondroitin sulfate (OSCS) - after identifying its chemical structure, and in a second study showed exactly how OSCS can kill by causing a severe allergic reaction. The papers were published online in Nature Biotechnology and the New England Journal of Medicine, respectively.

Dialyzors trust their lives to the idea that medications are what they're suppose to be but it's not just medications. We trust our lives to everyone involved in the provision of dialysis. The machines have to beep when they're suppose to beep.  Artificial kidneys - the dialyzers - are suppose to be sterile without any toxic elements. When a 4x4 bandage says it's sterile, we assume it's sterile. When soap says it's antibacterial we assume it's antibacterial. We assume that povidone-iodine is povidone-iodine. There is no way for those being dialyzed to confirm if any of this is true - dialyzors have to trust that there are checks in place; we assume that there is a system in place to ensure quality. We trust that people are doing their jobs and if people do their jobs we trust the system ensures the result we want.

In this case because of a chain of purchase decisions we ended up trusting our lives to anonymous Chinese pig part suppliers, which is not something any sane person would choose to do, but this was done in the name of economic efficiency all the way down the supply chain. And generally I imagine everyone did their job - shuffling the proper paperwork and trying to save a couple cents at each manufacturing step. But there was a flaw. The system relied on anonymous Chinese pig part suppliers. That was the system, trust anonymous Chinese pig part suppliers.

I know we can do better than that.

DaVita CEO Kent Thiry interview on YouTube

It's interesting to compare this video interview with the CEO of one of the two large for profit dialysis providers (LDO), with the interview in Renal Business Today with the CEO of a small community based nonprofit dialysis provider (SDO).

Thiry (LDO CEO) identifies his job as "creating a successful, sustainable business" in order to "create a special environment for people to work in; to build a special place to enrich people's lives". Jackson's (SDO CEO) mission is to "improve the kidney health of NKC's community." I'm sure they both try to be good places to work.

Dialysis and CKD Blog Report April 24

Welcome As the Pump Turns - the first blog I'm tracking from the dull end of the needle. Know any other blogs from the dull end of the needle? Send email or comment. (checked 4/24 at 2:00PM)

• The life of a 20-something with Lupus goes over what she has learned about skin care
• Kaply Inc. hates Comcast as much as I do; chair dances, needs ISP
  
• On the road to a cure explains the Ask the Experts section of site
• I am. Are you? myth debunking; donor registration hits Chicago; Illinois politician to honor video contest winner
  
• Toastiest votes; another cute pet pic
• Jack's kidney adventure Passover diner, road trip, banquet and dialysis - one post covering the gamut; gets on dialysis, thinks about Earth Day, likes cars though
  
• Kamal Shah thinks deep thoughts (God kills moms and dogs because he has to - Van Halen)
• Eating well on dialysis provides a classic Caesar Salad recipe
• Team teddy bear promotes an idea on the Starbucks website on a way to support PKD advocacy
• Kidney Notes has picture of kidney from The Body
• Let us consider one another had a good run and is enjoying a good day
• Really I'm as old as I feel is a hockey fan; doc leaves message - will now worry until Monday
• Chronic positivity 101st treatment goes smoothly; GoldenDoodle report
• Tasty kidney pie promotes Home Dialysis Seminar (will look for post call report)
• PKD & dialysis gets the right medications
• The truth about dialysis for patients promotes home dialysis newsletter
• My kidney blog is down for a while
• The dialysis diary notes size of renal industry; links to HDC Qb article by Agar
• Nathan's PKD gets a chest exray
• As the pump turns has picture of Calciphylexis (holy crap); hears it all from dialyzors

DEKA/Baxter - how's that going?

In the Renal Business Today interview NKC CEO Joyce Jackson reflects on NKC's past and future with home hemodialysis - remembering NKC's participation with the Aksys PHD's FDA 510(K) trial. NKC was also the launch site for the Aksys PHD after it received FDA approval -  in the late summer of 2002 I was the first person to train and use the PHD.

Turning to the future:

We’re [NKC] really interested in DEKA’s announcement that they are working with Baxter. Dean Kamen’s firm is taking the Aksys technology and trying to turn it into the next version of home hemodialysis machine. We’re very interested in how that’s advancing.

Indeed we are.

I visited DEKA last September but I have no idea about the project's status. Baxter's development of a home hemodialysis machine would seem to be a good fit if Baxter/Fresenius takeover rumors are true. I hear FMC's Baby K is caught in a FDA rules tangle - the timing could be right to start fresh with a DEKA designed dialysis device.

Washington Post coverage of phosphate control in CKD5

Phosphate control gets coverage in the Washington Post Cutting Phosphate May Protect Kidney Patients From Heart Trouble:

"One of the kidney's functions is to help maintain a constant balance of phosphate in the bloodstream," senior author Dr. Keith A. Hruska, director of the Division of Pediatric Nephrology and professor of pediatrics, medicine and of cell biology and physiology, said in a prepared statement.

"When kidney failure occurs, an excess of serum phosphate develops. It turns out that high phosphate serves as a signal that stimulates cells within blood vessel walls to become bone-forming cells and to deposit calcium crystals. That produces vascular stiffness that is a cause of cardiovascular mortality," Hruska explained.

Great to see a big national newspaper covering a detail of life with kidney failure aka Stage 5 CKD. However, throughout the rest of the article CKD is used where Stage 5 CKD or CKD5 is meant:

Based on the evidence from this and other studies, the U.S. Food and Drug Administration recently decided to extend the label of phosphate-binding drugs on the market. These drugs -- calcium acetate (PhosLo), sevelamer (Renagel) and lanthanum carbonate (Fosrenol) -- will now be labeled to indicate they are approved for treatment of high serum phosphate levels in CKD patients.

About 19 million Americans have chronic kidney disease.

That isn't exactly right but I'm conflicted because in many ways it is better than saying ESRD which is the usual term. It would have be exactly right if the Post would have just said Stage 5 CKD and then said about 350,000 Americans have Stage 5 CKD.

Those 19 million Americans with early stages of CKD, stages 1 through 4, do not generally need to take binders. And actually the National Kidney Foundation says "26 million Americans have CKD and another 20 million more are at increased risk".

Northwest Kidney Centers 2007 Breakfast of Hope video

This is the video that was shown at last year's Breakfast of Hope (this year the NKC Breakfast of Hope is May 22nd). This video features a family I've gotten to know (see photo at 2:35 mark; look for me in back row between Muff and Madison) through NKC and through this video:

I'm a Table Captain each year at this great event. If you can be in Seattle on the 22nd of May drop me an email and I'll sign you up to sit at one of my tables. After the 75 minute breakfast there will be a book signing with Graham Kerr (the Galloping Gourmet) and I'll introduce you to Muff as well as this year's video subject who I've just met over at Kidney Space.

NKC is an awesomely cool organization.

Benefits of Daily Dialysis

Tomorrow at 2PM Eastern time (GMT - 5) there will be a live web conference. Register now or participate by calling 1-800-681-4776; the participant passcode is 902324. Erich from Tasty kidney pie will be doing the presenting on the Benefits of Daily Dialysis. It is free to participate; I think it will last about an hour. No word on whether it will be available to listen to after the fact.

Joyce Jackson interview

Northwest Kidney Centers (NKC) President and CEO Joyce Jackson Interview with Renal Business Today is very good.  I've tried to cover some of the same territory  here, here and here. In fifteen questions the interview covers a lot of territory including home dialysis, barriers to home dialysis, small provider challenges, Medicare reimbursement reform, and what it means to be a community based nonprofit healthcare provider:

Being nonprofit at our organization is all about attitude; it’s about our approach and it’s about our actual outcomes. And that seeps into everything we do. It’s all about advancing the field. I’d expect this of all nonprofits, not just the Northwest Kidney Centers because if we don’t, as a nonprofit, add that benefit back into the community, then really we are no different.

NKC goes beyond what Medicare requires, working to improve the kidney health of the community here in Washington. And with the new Kidney Research Institute NKC is building with the University of Washington, NKC is working to improve the kidney health of the world.

Renal friendly fast food - does it exist?

Maria Karalis, RD, CSR, LD takes us to eat in the fast food world. Putting aside the salad bar there isn't much good to be said about the options at the main burger chains - get  a plain burger at McDonald's? I understand that Maria is trying to find some middle ground and to be realistic because clearly a lot of people eat at these places - including a lot of people on dialysis - but this is not renal healthy food.

It is hard to see how fast food can go with conventional dialysis. Daily nocturnal dialysis makes the phosphorus and potassium less of an issue but the fat and salt is still a problem. The goal should always be to dialyze more and to take more time to eat. Just slow down. You can eat better and enjoy the food more.

Kidney Care Partners petition for Medicare changes

KCP is asking for CKD community support for a petition effort. The petition statement is:

I urge Congress to act this year to pass Medicare program improvements that will help kidney patients and slow the growth of kidney disease by establishing:

• Programs to educate the public and at-risk communities about the dangers and warning signs of kidney disease
• Pre-dialysis education for individuals with kidney disease to help slow progression of CKD and its complications and prepare for treatment after kidney failure
• Enhanced training for dialysis caregivers
• Program reforms to maintain patient access to high quality care by providing annual inflation adjustments for dialysis like those for all other Medicare providers

I urge Congress to support Americans with chronic kidney disease and kidney failure as well as health care providers through comprehensive kidney care reform.

I'll sign it and fax it in, I support each position. The only one that is at all contentious is the last one - the inflation updates. This issue has been kicked around on the discussion forums for years. I've always supported a way for there to be routine inflation updates. Inflation happens, there is no reason we shouldn't accommodate this reality.

It was the "pay fors" that weakened my support for past proposals, because with legislation it is always in the details. Cutting the entire dialysis program to fund inflation updates that would only partially restore the cuts is not something I could support - this was the approach suggested in last years brutal CHAMP Act - so my only concern is around what legislators will do to offset the increases in spending called for in the petition.

Home Dialysis Central announces new feature

The good folks at HDC are announcing a new way to learn about dialysis: the Webinar. They want to know what you'd like to see as a topic:

In May, Home Dialysis Central will be starting a monthly free, 1-hour Webinar series for our visitors.  We've been practicing, and our first speaker will be Dr. John Agar, from Geelong, Australia.

We haven't set the topics--yet, because we'd like your input. You'll see slides, watch the presenter speaking, and have a chance to type questions. So, here's your chance to ask for presentations on things YOU want to know more about. What do you MOST want to learn?  If you have an idea of who would be a good presenter, feel free to share that as well.

Head over to the HDC Forums and suggest your ideas by posting a response to this thread. If you've never posted to an internet forum now is your chance because HDC is one of the few places that allow people to post anonymously - you wont have to register (however there is no downside to registering and you'd be able to edit your posts).

Participating is fun. No matter your connection to CKD if you have an idea for a topic or a presenter drop in and leave a suggestion. Who knows one anonymous post could lead to more participation and the next thing you know you'll be writing stories three words at a time (start, Chapter 1, Chapter 2).

I'd like to present a topic. My presentation would be about the three fluid compartments in the body. If I can ever finish the PowerPoint I'd like to show the dynamics involved with fluid removal. After a certain amount of fluid gain, it's just not possible to get dry in a single treatment.

FDA document imagines nocturnal home hemodialysis machine

RenalWEB linked to the FDA document Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis which offers recommendations to industry about submitting a machine for the first steps towards nocturnal home hemodialysis (NHHD) approval. The FDA provides a list of:

"inherent design and operational properties, we recommend the NHHD system include several key design features, associated alarms, and fail-safe responses. We recommend you incorporate the following features:

• disinfection, cleaning, and reprocessing capabilities and cycles;
• dialysate conductivity monitor, if your device contains a dialysate mixing system;
• water conductivity monitor; if your device contains a water treatment system;
• pH sensor;
• ultrafiltration controller;
• air detector system;
• blood leak detector;
• patient disconnect preventers and detectors;
• temperature monitor;
• anticoagulant administration system;
• access port for external remote patient monitoring device;
• integrated remote patient monitor, if a component of your system; and
• fail-safe design features in the event of power failure."

I'm not sure what "patient disconnect preventers and detectors" could be built into a device but the FDA does seem keen on having numerous monitoring systems integrated into the design. I know it is a fear when one first contemplates home hemodialysis but how often does inadvertent disconnect happen (particularly excluding during the processes of cannulation or decannulaiton)? The FDA did introduce me to a new word: exsanguination. I share their desire to avoid exsanguination but where is the FDA's data to justify their fear? Many people are dialyzing over night at home, around the world and in the US - if this was a clinical concern wouldn't there be examples to point to? Wouldn't there be a case history?

The danger is that by requiring expensive and unnecessary features the FDA will make daily home nocturnal less available. Forcing people to stay with conventional dialysis is far more dangerous. Dialysis isn't deadly, kidney disease is deadly. Dialysis is the solution. The FDA should evaluate machines on their merits and the data.

Dialysis and CKD Blog Report April 21

Welcome The Dialysis Diary, a couple people check in. A quiet report without a lot of drama - just the way we like it (checked 4/21 at 6:30PM)

• The life of a 20-something with Lupus week three of home hemo and another good lab report (scale for some items must be different up north)
• Hasten down the wire goes RSS 2.0; still looking for viable business model for a writer
• Kaply Inc. has fondue fun
  
• On the road to a cure DC walk was a success, reports funding available from DOD
• I am. Are you? links Sun Times article; U of I has donor registration drive - pictures
  
• Toastiest blogs the pet pics
• Kamal Shah smartly follows up on some vague symptoms and passes tests with flying colors - the power of daily nocturnal?
• Team teddy bear gets to see the Pope during visit to Yonkers - great pictures
• Kidney Notes Starbucks poster has Russian writing
• Chronic positivity has had 100 dialysis treatments, reflects on the good and the bad (I was confused and thought 100 days; this makes loads more sense, congratulations); chronicpositivity.com redirects to blog; links to tragic story out of Ireland
• Stayin' alive is back wondering when the spring flowers will show (it'll come and yes it is very nice)
• My kidney blog is looking for cobloggers; blegs for theme help using new platform
• Writings on the cave wall grinds through a day short staffed at work
• My wife has lupus has to deal with multiple appointments and changes
• Nathan's PKD has a TB scare at work, which is worrying post-transplant
• The dialysis diary is daily at home - still has functioning digestive tract
• Dailyhemo flags the NxStage/DaVita web Conference series