Until June 1995, I was the primary physician at the Food and Drug Administration (FDA) responsible for reviewing all patient reports and toxicologic and biochemical data for the Menlo Care products that contained Aquavene. In the recent report by Mermel and associates [1], the information presented is in direct conflict with findings determined by the FDA's scientific review staff.

I can state that Menlo Care's Aquavene products have successfully met FDA's "recent" safety and efficacy requirements. Scientific data produced by the FDA after multiple inspections of Menlo Care's facilities and records have shown no problem with the Landmark catheter or Aquavene material. I am disheartened that misleading information contained in this report may unnecessarily deny patients the benefits of the Landmark catheter.

The authors cite the FDA's database to support their contention that problems have been linked to Menlo Care's Landmark catheter. It is well known that all of the FDA's adverse-event databases contain incomplete clinical information. Adequate clinical data are rarely available to establish a definitive cause for an unanticipated event. When similar reactions occur with more traditional intravenous catheters, health care providers would be more likely to associate the event with the therapy given rather than with the catheter used.

Extremely rare, generally self-limiting adverse events have occurred in association with the use of Landmark catheters in a small number of patients. These events have never been scientifically established as being directly attributable to the Landmark catheter.

In response to Dr. Maki's comments [2], the analysis of an unexpected reaction requires as complete a clinical picture as possible. No valid scientific data had been presented to the scientific review staff of the FDA to support Dr. Maki's leap of faith regarding the cause of adverse events.