[Editor’s Note: Because the opinions in a letter to the editor are solely those of the letter writer, it is impossible for an editor to withdraw or retract a published letter from a reader. Therefore, the above communication from Mr. LeBlanc was referred to the writer of the original letter to see if he wished to retract it. Below is Dr. Tinker’s response.]
To the Editor:
Ignoring the facts that Gensia Sicor has chosen to call me a "parrot" and has chosen to imply that I am somehow connected to the manufacturer of Diprivan (which I am not in any way, financial or otherwise), I think a reply to their letter on the merits of the issue is in order.
First, they chose to add the sulfite, not me. Second, they did no human testing – in asthmatics, or in people allergic to sulfites, or in anyone else to my knowledge. Third, none of this information was discussed by the FDA Advisory Panel on anesthetic drugs prior to approval of the new formulation. While I realize that it is not an FDA requirement for the manufacturer to do so, a full discussion by our peers on this FDA Panel could have been requested by the manufacturer. Such a discussion might have resulted in a recommendation to test the new formulation, or it might not have. I respect this Panel, because it is composed of our peers in anesthesiology. If future human testing and/or full FDA Advisory Panel discussion results in a clean bill of health for this new formulation for propofol, with no contraindications or restrictions, then a proper process will have been carried out. After that, all we’ll have left to worry about is whether each and every user will read the label on each vial of emulsion, to see if the hospital pharmacy has changed brands without telling the anesthesia practitioner.
The response to my letter has been remarkably positive; people seem thankful for having had this issue pointed out to them. Anesthesia caregivers are skilled professionals. They will make their own decisions about whether to use this formulation or not – now that they know it is different.
John H. Tinker, M.D. Professor and Chair University of Nebraska Medical Center Omaha, NE