Cloak & Dagger: Wyeth Allegedly Disguised Sales Reps as Doctors to Sell Kidney Drug

Last Updated May 25, 2010 12:03 PM EDT

The whistleblower suit filed against Pfizer (PFE) yesterday over alleged off-label sales of the kidney transplant drug Rapamune reads in part like a spy novel. It describes the cloak-and-dagger methods that the company's employees allegedly used to persuade doctors to use the drug in ways they shouldn't, including disguising reps as white-coated doctors, altering sales software to prevent off-label material being recorded, and arranging dinners at which the seating plan was controlled so that guests would always sit next to a doctor who was already enthusiastic about off-label use.

Ethical problems don't announce themselves in company-wide emails with the heading "Ethical Problem," so it's often not easy for managers to notice when their employees are crossing a line. One red flag, however, is if business requires some kind of deception or deliberate omission. That, allegedly, was the case at Wyeth before it was acquired by Pfizer.

The most sinister allegation in the case comes in the form of a description of how far Wyeth went to infiltrate the ranks of kidney transplant doctors and nephrologists, including wearing lab coats and making treatment suggestions for hospitalized patients:

From 1999 through at least 2003, Wyeth [Transplant Account Managers -- i.e., drug reps] routinely accompanied transplant physicians on hospital rounds, sometimes wearing white lab coats. Some physicians introduced the TAMs to patients as pharmaceutical sales representatives, but others said nothing about them to their patients. Occasionally, TAMs even attended transplant surgeries. After rounds, TAMs frequently attended physicians' meetings during which the physicians would discuss patients' treatment regimens. During these meetings, TAMs often suggested that specific patients might benefit from Rapamune as part of their treatment regimens.
Another red flag came in September 2005, when the company changed its software in what might be interpreted as a preemptive cover-up:
...Wyeth management "upgraded" Salesworks, which was an electronic company system designed to record physician "calls" by TAMs. The "upgrade" was made so that TAMs could no longer place details about sales issues discussed with physicians in the notes section. Relator Sandler believes that the change in the system stemmed from Wyeth's fear that the Company would be charged with off-label marketing several Wyeth drugs, including Rapamune. Wyeth management also advised TAMs not to use "alternative" methods like "handwritten notes or e-mail" to commemorate the selling interaction. Wyeth justified the change in Salesworks by stating, "[w]e believe that it is appropriate and will serve the Company's best interests in the future."
If you've ever organized a dinner party or a wedding you'll know how much of a headache the seating plan can be. Wyeth's reps made seating an art form, however, when it came to transplant doctors invited to their sponsored dinners. Nothing was left to chance:
Before all American Transplant Congresses ("ATC") until 2006, Wyeth management painstakingly coordinated dinners for key physicians attending the conference and designed seating charts strategically to place kidney and extra-renal transplant physicians with positive experience using Rapamune next to transplant physicians with no experience using Rapamune so that Wyeth marketing and sales personnel could segue into off-label discussions of Rapamune and generate extra-renal and other off-label Rapamune sales.
Lastly, reps were warned to closely examine the name badges of other conference participants so as not to inadvertently pitch FDA officials with illegal ideas:
Wyeth went so far as to identify cities in Maryland and other locations where FDA offices were located so that TAMs could examine the cities contained on conference name tags.