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 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, 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 and Aug. 9 articles).  Much of the dialysis-related content of these articles was largely based on a scientific article in Kidney International, 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).  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 care providers, 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?

Comments

[Bill Peckham]

One edit:
" 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.

If 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 pay corporations to care more about dialyzors than dialyzors care about themselves. However, we could pay dialyzors to manifest concern for their 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?

[Gary Peterson]

Thanks, Bill, I made the edit.

I think that it takes years for anyone to become an effective safety monitor. I think that almost all care providers -- and some motivated dialyzors after a year or two of in-center dialysis -- realize that they are most safe and in control at home. Putting patients in the position of judging and/or reporting on the staff that cares for them could create many retaliatory and personality-based problems.

Physicians and nurses are supposed to be advocates for patients. Their licenses require them to report situations when patients are in danger. However, with so few and so powerful employers in the dialysis field, these physicians and nurss essentially end their dialysis/nephrology/publishing careers if they either report problems or write about them... unless they are well-established outside of FMC/DaVita.

Perhaps patient organizations should push the large for-profit providers to establish permanent patient-led focus groups that are dedicated to improving dialysis care.

As for the elevated monthly labs, here are some thoughts. The monthly labs are typically drawn after a three-day weekend, when serum bicarbonate levels are lowest. It is always a less-than-ideal marker of the patient's acid-base status.

Even though most dialysis laboratories specialize in analyzing blood of dialysis patients, their lab result forms have provided reference ranges of normal serum bicarbonate levels for non-dialysis patients (20-29).

In talking to physicians, I have found that even those that were most attuned to the Granuflo/bicarb issue did not see evidence supporting the lowering of dialysate bicarbonate levels en masse until 2009.

[Lana Schmidt]

The medical director, Dr Mark Greenwell, retaliated against me after I filed a complaint with the Heartland Renal Network.
For 1.5 years I felt that the home hemo nurse had threatened my life in several different ways.

The doctor yelled at me for several days when I was in hospital; called me names; lied about what the Heartland Renal Network said, he said, that they said, I had to be removed from the home hemo program.

Someone/hospital security should have pulled him off me! He was belligerent toward me…
I had just had surgery, general anesthesia, had pneumonia, hemoglobin had bottomed out, etc…

He said that I could no longer be in the home hemo program, only offering me in center which he knew I could not live on.
I told the Heartland Renal Network, they did nothing.
I also reported it to cms and they said they couldnt do anything about it because it was not in my medical records!

There are no policies or procedures in place or punishments for retaliation to patients.
In addition, even though the renal network is suppose to protect patients, they tell me they don’t. All the information on the renal network website implies that patients rights are protected, but they are not.
You're right there is no protection for patients and it is scarey.

[Lana Schmidt]

How can the kidney world allow Ken Thiry ceo of Davite, the highest paid, make public a statement .."it is not about the patient",
in his presentation at the UCLS Business School.
http://www.youtube.com/watch?v=JowmBdx4nFw&noredirect=1
Go to the 1:09:35 mark of the YouTube video when a student asks a question. No wonder DaVita has such a bad reputation, especially with its own patients and the patients cant do anything about it.