This week Fresenius Medical Care announced that it had formed a new renal pharmaceutical company, Vifor-Fresenius Medical Care Renal Pharma Ltd., as a joint venture with Galenica Ltd. The company is designed to develop and distribute products to treat iron deficiency anemia and bone mineral metabolism for pre-dialysis and dialysis patients.
This potentially creates an enormous number of conflicts of interest that should concern the dialysis patient community, dialysis care professionals, and policymakers for several reasons.
Do corporate goals influence the administration of medications in dialysis centers? One only needs to look at anemia drugs (ESAs). Under current policies, the more ESAs the patients receive, the higher the profits the dialysis provider enjoys. Examining the recent USRDS annual reports, of the three largest dialysis providers in the US (FMC, DaVita, and DCI), the one that administers the lowest doses of ESAs to its patients is the only one that is a non-profit corporation (DCI).
This is a case where one company will make the drugs and administer them to the patients as their caregivers. The drug company employees and doctors and nurses in the dialysis unit will all report to corporate entities with common financial goals. Will those who raise concerns or red flags — about a drug's effect, drug reactions, dosage amounts, or better medications to use — be seen as helpful or harmful to corporate goals? What usually happens to internal whistleblowers? As demonstrated by this September 15, 2010 FDA warning letter to Fresenius Medical Care, there are serious questions as to how thoroughly a corporation will investigate and address its own shortcomings.
Will Fresenius Medical Care fund studies that are designed to highlight the benefits of their medications and minimize their risks? Will adverse and disappointing results be hidden? Will they fund studies to show the inferiority of competitors' drugs? All these actions have been common in the pharmaceutical industry.
Will corporate treatment protocols be built around encouraging the use of the corporation's medications?
If nephrologists and nurses have stock options in the corporations, what and where are their best interests?
A final point: The need for these pharmaceuticals is also largely dependent upon the amount of dialysis therapy the patients receive. If patients receive the minimum amount of therapy that is normally provided with standard, in-center care, they will continue to need significant doses of these medications. There is a growing consensus that if patients receive longer and/or more frequent hemodialysis treatments, they require fewer medications and smaller dosages. If FMC is selling these drugs to all other dialysis providers, they have an interest in retaining short, 3x/week treatments as an industry standard.
Keep in mind that most dialysis patients are no longer sources of profit to the dialysis provider corporations if they survive on dialysis longer than three years.
While I believe there are many compassionate and caring people in these dialysis provider corporations, in today's world a large corporation must and will act in its own short-term interests… despite their intentions. This joint venture nullifies too many of the needed checks and balances for safe and effective patient care.