Now that we have determined what 3M is up to with the rabbit let's see what else they used the "irrelevant" rabbit for in other areas of the FDA Approval process.
You know 3M tested Aldara in the "eyes" of rabbits? If that was not bad enough, they injected them with IQ, they gave the rabbit I.V.'s of IQ, they made them eat it, they put Aldara up the vagina of rabbits, they soaked the rabbit with Aldara, they put patches over Aldara in topical experiments. In fact, the rabbit got the stuff applied every way imaginable and still , according to 3M, the rabbit did not respond by inducing cytokines nor did they, of course, have any of the typical side-effects. So, what is 3M up to using the rabbit for anything or any purpose having to do with Aldara research?
Well, it seems that 3M needed to present higher safety levels in several areas of their proposed FDA Approval data to overcome the true dangers that more accurate data would have shown. So, what better way to accomplish this feat than the use of data from an animal that simply cannot have a side-effect from the drug regardless of how much is applied, where you put it, or even if you make him eat it.
Ahhh the Rabbit. How 3M must have rejoiced the day their scientists reported to them that nothing happened to the rabbit. I can just hear them now, "We simply cannot make this rabbit respond no matter what we do. We were able to kill all the other animals but this damn rabbit for what ever the reason simply cannot be killed with the stuff." Surely, someone raised the issue that the rabbit data should not be used and just as surely someone at 3M gave the orders to include the rabbit data. It was no mistake that this data was used. It was a calculated, intentional use of data known by all at 3M to be erroneous data that they would use to exaggerate positive safety features for Aldara in the FDA approval process and eventually to YOUR OWN PERSONAL PHYSICIAN.
All throughout the literature for Aldara, you see statements referring to the rabbit if not by name then simply stated as "the animal data showed" or "animal data revealed" statements that refer to the rabbit data.
.1 Pregnancy (taken from 2009 3M / Graceway product insert sheet)
Pregnancy Category C:
Systemic embryo fetal development studies were conducted in rats and rabbits. Oral doses of 1, 5 and 20 mg/kg/day imiquimod were administered during the –15) to pregnant female rats.
Intravenous doses of 0.5, 1 and 2 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6 – 18) to pregnant female rabbits. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (1.5X MRHD based on BSA comparisons), the highest dose evaluated in this study, or 1 mg/kg/day (407X MRHD based on AUC comparisons).
.......No treatment related effects... Oh Really!!! What a Surprise !!!!
Here again, 3M knowingly uses the "irrelevant" rabbit data to help bolster the safety statement for Aldara in of all places under the title of Pregnancy. In this instance, they gave the rabbit I.V.'s of injectable IQ and low and behold there were no side effects. Wow, I wouldn't hesitate as a doctor to give my pregnant patient a round of Aldara off this safety statement "UNLESS" I was fully educated on what you and I now know about the rabbit secret.
3M has another huge scandal to explain which is comparing the oral dosing data with topical use of Aldara. This is a whole other scandal that we go into later. It's nothing short of an apples and oranges comparison.
In the Approval package, 3M projects safety profiles for topical Aldara through comparing oral dosing data to topical data which makes it appear that topically applied Aldara is so much less dangerous than is oral dosing.