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?