By Peter Laird, MD
On May 14, 2014, NxStage Medical Inc. issued a voluntary FDA recall of 140,000 to 150,000 concentrated dialysate SAKs from elevated levels of Aluminum in lots manufactured from April 2013 to February 2014. NxStage produces the only FDA approved portable home dialysis machine and is a popular choice for many patients who wish to maintain an active and independent lifestyle.
To date, NxStage has not revealed details on how this significant failure occurred. I recently discussed the aluminum event with a high ranking NxStage officer who stated that they are constrained by FDA regulatory provisions that prohibit full disclosure until the FDA investigation is complete.
NxStage outsources all of their lactated dialysate products to two companies, PiSA, the largest pharmaceutical group in Mexico and Rockwell Medical Inc. which signed an agreement with NxStage on March 8, 2013 to produce concentrated dialysate. Shortly after this agreement, the first contaminated lots of concentrated dialysate contaminated with high levels of aluminum appeared in April 2013. Many patients allege that Rockwell new to the NxStage lactated dialysate manufacturing process is the likely source of the contaminated concentrates.
Rockwell Medical Inc. produces mainly bicarbonate dialysate in competition with Fresenius dialysis products for the American dialysis market. Incorporated in 1995, my review of Rockwell public records reveals that this company has limited experience with lactate dialysis products which are produced in a complex process through fermentation.
The largest producer of lactate products in the world is Purac which has exceptionally low tolerances for aluminum and heavy metals. Purac manufactures pharmaceutical grade lactate with a max tolerance of 0.1 ppm (0.11 mcg/L) and is considered the gold standard producer of lactate products through out the entire world. In an extensive review of NxStage, Rockwell and PiSA public records, none of these documents listed the source of their lactate products, nor could I find direct agreements in public records with Purac. In addition, Rockwell has not responded to date to my queries for comments on this event.
While NxStage will not confirm that Rockwell is the producer of the tainted product, circumstantial evidence points directly to Rockwell as the source.
Should the FDA investigation conclude that Rockwell Medical is the source of the NxStage Aluminum contamination, investor relations may suffer in light of what many consider a solid future for this company nearing completion of a New Drug Application for their iron dialysate product, Triferic. It would also mark continued safety and quality concerns that has haunted Rockwell over the last several years.
In 2008, state inspectors at a South Carolina Rockwell plant found major safety and manufacturing violations in follow up to multiple customer complaints. (here) In 2009, thousands of cases of shipped dialysate was recalled after finding excessive levels of bacterial growth. (here and here)
In 2012, Dr. Richard Yocum, a former Rockwell senior vice president in charge of Rockwell's Triferic research alleged SEC reporting violations and fraudulant claims for their drug in development in a wrongful termination lawsuit. (here) Triferic is expected to soon enter an annual 700 million market for iron replacement. Although Rockwell prevailed in this lawsuit, the judge limited his ruling to the narrow question of whether Rockwell had the right to terminate Dr. Yocum's "at will" employment. (here) A private law firm initiated a secondary investigation into these allegations in 2013. (here)
With the ready availability of high grade, ultra-pure lactate products from Purac with levels at a fraction of those found in the NxStage lactate concentrated dialysate, the ensuing FDA investigation needs to uncover all of the details of this preventable event. However, should Rockwell Medical Inc. become the focus of this active FDA investigation, many will rightly, I believe, question their dedication to quality products.
In light of the impending FDA approval of Triferic after exhuberant results in their recent PRIME study, I myself will take the advice of a trusted colleague who once told me, don't be the first doctor to prescribe a new drug, nor the last. Until we have extensive evidence from Triferic's post marketing results assuming it will soon be approved, I certainly will not be one of the first patients seeking this companies new drugs.