A favorite Maxdad spin, shared by legions of pumpers, that O only caused 3 anaphylaxis deaths, and just those 3 deaths are all that needs to be resolved for O to return to market. The origin of that spin is from the FDA's announcement of O's voluntary recall which stated that dialysis centers had notified them of 3 anapylaxis deaths. That does not mean, ipso facto, that only 3 O deaths are under FDA investigation.
For example, Orwin himself referenced 5 O deaths that gave rise to the AFFY/Takeda decision to recall O: 3 from anaphylaxis and 2 that were deemed cardiovascular in nature. Since the product has been recalled, more O deaths have surfaced and need to be investigated too. As another example of facts behind O's recall, consider the WSJ article that reported "A total of 98 "adverse events" tied to the drug were reported to the FDA by Feb. 22 of this year, the day before the recall. There were 12 deaths among the reports to the FDA, but the cause of death wasn't specified..."
So the truth is not as simple as 3 anaphylaxis deaths need to be investigated and that is all that is preventing O's immediate return to market. Moreover, an interest reader/speculator/investor might also want to know tht the reliability of the EMERALD studies filed with the FDA to support O's patient safety for CKD patients on dialysis are now being questioned, too. For specifics, see my earlier post O Truth Starting to Emerge - A Sad, Questioned Legacy.
Actually, I am accurate. Here is an excerpt from the allegations contained in the Amended Complaint against AFFY filed in the Bartelt securities class action litigation that reports O's numbers of patient deaths (14) and adverse incidents.
Close to 100 "adverse events"1 tied to the drug were reported to the FDA
beginning in August 2012, including 14 deaths by February 22, 2013, the day before the recall.
The majority of these adverse events were reported to the FDA under a Case Type of
“Expedited (15-Day)” which the FDA defines as “submitted to the FDA by manufacturers;
these are reports containing serious, unexpected adverse events.” Further, there were over 60
adverse events reported to the FDA in March 2012, most of which were reported on a nonexpedited
basis and many of which also contained symptoms of allergic reactions. The
majority of these reports were reported directly by a healthcare professional, and presumably
occurred prior to the February 22, 2013 recall since they were reported on a non-expedited
1 An adverse event is defined by the FDA as “any undesirable experience associated with the
use of a medical product in a patient. The event is serious and should be reported to FDA when
the patient outcome is: Death; Life-threatening; Hospitalization (initial or prolonged);
Disability or Permanent Damage; Congenital Anomaly/Birth Defect; Required Intervention to
Prevent Permanent Impairment or Damage (Devices); Other Serious (Important Medical