I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: General Discussion => Topic started by: Bill Peckham on August 21, 2012, 10:46:19 PM
-
From the Fix Dialysis blog
http://www.fixdialysis.com/main/2012/08/it-is-a-scary-time-to-be-a-dialysis-patient-in-the-us.html (http://www.fixdialysis.com/main/2012/08/it-is-a-scary-time-to-be-a-dialysis-patient-in-the-us.html)
It Is a Scary Time To Be a Dialysis Patient in the U.S.
by Gary Peterson
On June 14th, the New York Times published an exposé (http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html) about Fresenius Medical Care (FMC) failing to notify non-FMC clinics of the increased risk of cardiopulmonary arrest with the use of its Granuflo product. The Times published a 6-page internal FMC memo that showed that it emphatically warned its own clinics of the danger in November 2011. A copy of this memo was leaked to the FDA by an anonymous source and FMC was contacted by the FDA on March 27, 2012. Two days later, FMC finally released a scientifically-vague, 2-page memo to non-FMC clinics using its products. On May 25, 2012, the FDA release a Safety Communication regarding alkali dosing errors and then followed up with a Class I recall of the FMC products on June 27.
One would normally expect a public outcry about FMC's actions. FMC appears to have failed to meet its legal obligations as a medical product manufacturer to inform the Food and Drug Administration (FDA) of this risk to patients, as well as warn the physicians that were utilizing its products. One would also expect the professional organizations involved in dialysis care to openly question FMC's motives and demand an accounting for their actions. One would expect the organizations created by federal government to oversee dialysis patient safety, the ESRD Networks, to call for an investigation and would want assurances that this would never happen again. One would especially expect dialysis patient groups to demand a public explanation of FMC's actions and to speak out about the need for medical device manufacturers and dialysis care providers to be completely honest and forthcoming about issues and problems that affect their health, well-being, and survival.
To date, not one professional organization — medical, nursing, or administrators — has commented on this New York Times article. Not a single ESRD Network has publically addressed the issue. Not a single patient organization whose own patients were using the Granuflo product has commented on this article.
FMC has provided no public comment on the New York Times story. Since the article was published, they have offered no explanations, apologies, or even a statement of concern to reassure patients.
No one has come forward to question FMC on the powerful conflicts of interest they have created for their employees within their vertically-integrated company. What are the priorities for an employee in a multi-billion-dollar, for-profit company that both produces dialysis products and also owns and manages a large share of the dialysis facilities in the U.S?
No word has been heard from Ben Lipps or Rice Powell, to whom both Drs. Maddux and Diaz-Buxo report. Why won't this simply happen again with another FMC product?
The only group that has been heard from in force are the personal injury attorneys.
Only one small home dialysis patient group (http://homedialyzorsunited.org/2012/06/14/open-letter-to-ben-lipps/), whose members do not use the Granuflo product, has demanded a public accounting from FMC for their actions.
Only one physician has made a point of publically speaking out and challenging dialysis care professionals to do what is right: Dr. Jeffrey Berns.
In the last two months, powerful stories have appeared about the inappropriate treatment of dialysis patients. The Washington Post wrote about the overuse and overspending involved with anemia drugs for decades, including the dialysis industry (see July 19 (http://www.washingtonpost.com/business/economy/anemia-drug-made-billions-but-at-what-cost/2012/07/19/gJQAX5yqwW_story.html) and Aug. 9 (http://www.washingtonpost.com/business/economy/medicare-overspending-on-anemia-drug/2012/08/09/gJQAeWTtjX_story.html) articles). Much of the dialysis-related content of these articles was largely based on a scientific article in Kidney International (http://www.nature.com/ki/journal/v82/n2/full/ki201276a.html), a European journal, that had a single author, Dr. Daniel Coyne. Is there any chance that this article would have been accepted by a U.S. journal that also accepts Amgen advertising and has powerful FMC and DaVita physicians on its oversight board?
The first Washington Post article reports on a 1995 Amgen safety study done on dialysis patients that neither Amgen nor the FDA will now release. An FDA spokesperson states that the original report has been "misfiled."
In early July, DaVita announced a settlement of more than $55 million in a whistleblower law suit involving anemia drugs (background info (http://www.mcguirewoods.com/news-resources/item.asp?item=4506)). No wrongdoing of any kind by DaVita or its employees was acknowledged.
Are leaked documents, European journals, and whistleblower suits the only routes available to those who want to protect their U.S. patients and keep their livelihoods?
The bigger story here appears to be the major corporations' abilities, power, and influence to control professional organizations and their individual members. Instead of being a culture of safety, as is touted to the public, it instead appears to be a culture of secrecy that is sustained by money and fear. Instead of being a healthcare delivery system, dialysis care in the United States may be better described as a money delivery system ── to caregivers, their organizations, their corporations AND to nearly all patient organizations ── which accept unnecessary risks and possible harm for patients as a cost of doing business.
Who is protecting U.S. dialysis patients when the financial interests of these corporations conflict with the patients' best interests?
-
One edit I think should be made:
" ... a money delivery system ── to carePROVIDERS, their organizations ..."
The organizations that receive money by definition never "give" anything.
I think this nexus of money and influence, put's both money and a stick in the hands of the large dialysis organizations. The patient groups you chose not to name but I will, AAKP, DPC, RSN, NKF, rely on industry funding to accomplish work prescribed by the funders i.e. industry. The thinking goes You can't do the good things we do if you challenge the funders.
f Medicare wants a culture of safety they must bypass the providers and direct incentives at the beneficiaries themselves. If dialyzors were being paid to be monitors of and participants in their own safety, the LDOs would be compelled by their patients to be better actors.
The base problem here is that to work the system really depends on engaged, and aware, beneficiaries. There is not enough money in the Treasury to pay corporations to care more about dialyzors than dialyzors care about themselves. However, we could pay dialyzors to manifest concern for their own care.
On thing about this Granuflo issue in particular though - why wasn't the elevated bicarb picked up by the MCP physicians in the monthly labs?
-
my impression, is that because of the nature of our illness, we are disposable, since we are living on 'borrowed time' anyway. This mindset was very apparent with my own nephrologist, whose final word when I was requesting to do extended dialysis was 'well, at least you get a few extra years'! I am 49, pretty nmuch his age and with a defendant child at home. Needless to say, I am meeting with a new nephrologist today, who from anecdotal evidence is an exception to the rule; he cares about his patients and gives their needs his priority. Time will tell! From Cynical of Georgia!
-
Your article is disturbing, but what is even more disturbing is the future outlook for dialysis patients. Both parties have been cutting Medicare, either with nickel and dime measures like Obama, or with crazy cuts ala Ryan. Once America falls over the fiscal cliff, and it will, they're probably going to throw us under the bus.
-
Your article is disturbing, but what is even more disturbing is the future outlook for dialysis patients. Both parties have been cutting Medicare, either with nickel and dime measures like Obama, or with crazy cuts ala Ryan. Once America falls over the fiscal cliff, and it will, they're probably going to throw us under the bus.
When FMC bills medicare over $1300.00 a day for me to do home PD maybe there should be cuts. I think $300.00 a day would be excessive!
-
Your article is disturbing, but what is even more disturbing is the future outlook for dialysis patients. Both parties have been cutting Medicare, either with nickel and dime measures like Obama, or with crazy cuts ala Ryan. Once America falls over the fiscal cliff, and it will, they're probably going to throw us under the bus.
When FMC bills medicare over $1300.00 a day for me to do home PD maybe there should be cuts. I think $300.00 a day would be excessive!
The average Medicare allowed rate for PD is $750/7 or about $107/day +/- $4.
-
Then DaVita and FMC should bill... the allowed rate for PD of $750/7 or about $107/day +/- $4.
But they don't..... That is one huge problem.
Another problem..... How do we shut this business down without half of us dying.... only because the other half of us is with DaVita?
Maybe DaVita Patients should go picket FMC on our days off. We certainly can't go very long without dialysis!! I'd be in big trouble after 4 days.
They kind of have us by the nuts (so to speak) and probably 3/4 of the people are too sick to fight back or care.
:waiting;
-
*
-
Then DaVita and FMC should bill... the allowed rate for PD of $750/7 or about $107/day +/- $4.
But they don't..... That is one huge problem.
Why is it a problem at all? let alone a huge one?
All the billed rate tells you is how much they charge private insurers and even then for all but the smallest insurers, those with less market power, they don't get paid the full amount.
-
The latest bill I got for 1 month was over 55K. That makes me NOT trust them. Trust is a huge issue when the big dialysis centers THEN want us to write our congressmen that they need more money.
TRUST = HUGE ISSUE
-
This has the potential to be a massive lawsuit with 400,00 plaintiffs.
Too many of the symptoms or side effects that dialysis patients have experienced have been generally lumped into the "idiopathic" category. Is there a link to bicarbonate levels in the blood to the agony of some of the side effects of D?
In accordance with HIPAA guidelines, I have drafted a letter to my clinic in my best, one year of law school legalease to get a copy of my medical records, treatment protocols and drug and dialysate solutions to see if my unit has been using the Fresenius products. If there is a need, I will post a sample copy of my letter for others to use.
I note that there are already pages of lawyers looking for clients if one does a Google search for "Fresenius lawsuit." The sharks are circling because they smell blood in the water.
-
The sharks are circling because they smell blood in the water.
Best to be the shark
http://www.facebook.com/photo.php?fbid=266718643432084&set=a.263430323760916.49786.263412187096063&type=1&theater
-
This has the potential to be a massive lawsuit with 400,00 plaintiffs.
Too many of the symptoms or side effects that dialysis patients have experienced have been generally lumped into the "idiopathic" category. Is there a link to bicarbonate levels in the blood to the agony of some of the side effects of D?
In accordance with HIPAA guidelines, I have drafted a letter to my clinic in my best, one year of law school legalease to get a copy of my medical records, treatment protocols and drug and dialysate solutions to see if my unit has been using the Fresenius products. If there is a need, I will post a sample copy of my letter for others to use.
I note that there are already pages of lawyers looking for clients if one does a Google search for "Fresenius lawsuit." The sharks are circling because they smell blood in the water.
Thank you for your post. I would be very interested in getting a copy of the letter, if possible. My email address is writesoul@msn.com. My name is Robin. Thank you.
-
rfranzi:
PM sent.
-
This really disturbs me. I have been sent to the ER several times with chest pains (no heart attack as yet!) And I'm getting ready to start Home D. Wondering if I should contact one of the sharks for info.