November 4, 2011 is a day that should live in infamy.
On November 4, 2011, Fresenius Medical Care (FMC) published an internal memo that held very disturbing news — news that could potentially cost the company billions of dollars. Reports had emerged that 941 GranuFlo patients had suffered heart attacks linked with the use of the company’s dialysis product. Doctors and company officials were confused and concerned.
The company’s Chief Medical Officer, Dr. Raymond Hakim, spearheaded an investigation with other Fresenius doctors. In their “summary and findings,” the doctors said that “borderline elevated pre-dialysis bicarbonate levels and over alkalosis are significantly associated with 6 to 8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility.”
The high levels of serum bicarbonate in patients caused particular worry. The authors wrote: “in light of these troubling findings, we strongly recommend that physicians adjust dialysate bicarbonate prescriptions monthly for individual patients, with immediate attention to patients with serum pre-dialysis bicarbonate levels of greater than 24 mEq/L.”
That language may sound technical. But the implications could not have been clearer. A drug that made Fresenius several billion dollars a year was likely killing many patients.
Instead of going public with this information – warning non-Fresenius clinics about the dangers or informing the Food and Drug Administration (FDA) – Fresenius kept mum. It ignored its own dire internal memo and pressed ahead with business as usual.
Dr. Raymond Hakim left the company just 12 days after this memo went out.
The suppression of this memo was no outlier. It constituted just one dramatic chapter in an epic saga of fraudulence, malfeasance, greed, and manipulation that has played out for over a decade.
Before we can understand the history and politics of the GranuFlo controversy, we first need to take a detour into the biochemistry. How, exactly, does GranuFlo work? What about this drug makes it “go wrong” for certain at risk patients?
Stay tuned for the next post, when we will dive deep into the critical biochemistry. For now, if you need an evaluation of your GranuFlo case, please call Davis & Crump at 800-277-0300 or email us at info@daviscrump.com.
