AUTH/3453/1/21 - Anonymous v Pfizer

Conduct of a representative

  • Received
    03 February 2021
  • Case number
  • Applicable Code year
  • Completed
    15 July 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, non-contactable complainant who described him/herself as a concerned doctor, complained on behalf of his/her gastroenterology team about a named Pfizer Limited representative and his/her promotion of Xeljanz (tofacitinib).

Xeljanz was indicated, among other things, for the treatment of certain adult patients with moderately to severely active ulcerative colitis (UC).

The complainant alleged that the representative had called on the team and emailed and telephoned them using different names to try and secure appointments at a time when he/she had been advised that, because of concerns over Covid-19, the team did not want to see representatives.

The complainant also alleged that the representative had promoted his/her product outside of the licensed indication and had stated that this would help patients with Covid-19 and irritable bowel disease, by keeping them out of hospital. The team currently did not know of any data that tofacitinib was effective in those patients over and above the team’s standard of care.

The complainant also stated that there had been a loss of trust as the representative had asked the team to consider writing up case studies without patient consent.

The detailed response from Pfizer is given below.

The Panel noted that the complainant had provided the name of the representative but insufficient information so that the particular circumstances could be clearly identified. The Panel noted that the parties’ accounts differed.

The Panel noted Pfizer’s submission that the named representative strongly denied the allegations of over contacting, using different names or disrespecting the wishes of any health professional, department or organisation on his/her territory and its investigation of the named representative’s activities had found no evidence of such. The Panel noted that Pfizer had identified two health organisations that had requested no industry contact and that there was no record of the named representative having had any calls or contacts with them during the pandemic. Further, it had not received a ‘banning order’ from any health organisation or Trust as suggested by the complainant.

The Panel noted Pfizer’s submission that the named representative denied discussing data for tofacitinib in patients with Covid-19 infection with any health professionals and that it had found no evidence that the representative had promoted a Pfizer medicine outside its authorised indications or that he/she had made inaccurate, misleading or unsubstantiated claims about the medicine’s use in patients with Covid-19.

The Panel noted that Pfizer stated it had ensured that throughout the pandemic, its representatives had received relevant, detailed, certified briefings on both the specific medicines that they promoted as well as on the wider health professional engagement framework that should be applied. Based on the evidence before it, the Panel did not consider that Pfizer’s briefings advocated any course of action which would be likely to lead to a breach of the Code in relation to calls and contacts with health professionals and other relevant decision makers, nor with regard to the promotion of tofacitinib.

The Panel further noted Pfizer’s submission that the representative denied having asked any clinical team to consider writing up case studies without patient consent, and that it had not instructed or briefed representatives to do so.

A judgement had to be made on the available evidence bearing in mind the extreme dissatisfaction usually necessary on the part of an individual before he or she was moved to actually submit a complaint and that the Panel could not contact the complainant for more information. The Panel further noted that the complainant bore the burden of proof and did not consider that he/she had established his/her case on the balance of probabilities. The Panel therefore ruled no breaches of the Code.