AUTH/3200/5/19 - Director/Media v Napp

Arrangements for a meeting

  • Received
    21 May 2019
  • Case number
    AUTH/3200/5/19
  • Applicable Code year
    2001
  • Completed
    03 April 2020
  • No breach Clause(s)
    19.1
  • Breach Clause(s)
    2, 9.1, 18.1 and 19.1
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Advertisement
  • Appeal
    No appeal
  • Review
    To be published in the review

Case Summary

A BBC radio 4 programme broadcast in May 2019 and a subsequent article published on the BBC website entitled ‘Doctors used as “guinea pigs” in opioid painkiller promotion’ were critical of the activities of Napp Pharmaceuticals Limited.

The PMCPA Constitution and Procedure is such that public criticism of the industry is taken up by the Director and dealt with as a complaint under the Code. The article included criticism of a meeting sponsored by Napp and held in New York and was therefore treated as a complaint under the Code.

The article and radio programme referred to UK pain specialists staying in a smart hotel in New York, eating in upscale restaurants and attending Broadway shows, paid for by Napp Pharmaceuticals. No date was given for the meeting other than the early 2000s.

The article and radio programme also referred to some pharmaceutical companies monitoring prescribing rates of doctors who had attended paid for trips and deliberately targeting those ‘they thought they could influence’

The transcript of the radio programme referred, inter alia, to the views of a health professional who was a consultant in chronic pain on the use of opioids in chronic pain. The transcript also referred to certain publications, and whether clinical trials related to how medicines were used in real life and whether this misled doctors. Reference was made to Purdue Pharma in the US and a settlement in relation to OxyContin. The transcript referred to Purdue’s response that it did not exert undue influence over key opinion leaders with regard to medical education programmes which the company sponsored but did not control the content of. This was followed by a discussion about whether the same tactics were used in the UK.

The transcript of the radio programme stated that in early 2000 Napp, which according to the transcript was the UK company related to Purdue Pharma, flew groups of UK doctors specialising in pain to New York to meet key opinion leaders. Reference was made to a lovely hotel and the amount of down time to do things on your own. There was entertainment laid on and this included a Broadway show and eating in nice restaurants. There was a trip to the headquarters of Purdue Pharma. It was advertised as an educational package and the idea of meeting the international thought leaders was described as a great hook for the health professional.

The transcript also referred to an editorial in a 2007 British Pain Society newsletter referring to the conflict of interest this kind of hospitality created for doctors. The health professional who was a consultant in chronic pain referred to feeling duped that the trip was going to facilitate connections with people he/she would not otherwise meet when in fact he/she was ‘just a guinea pig to promote prescribing of a class of drug’. The educational initiatives were said to be run by the marketing departments of pharmaceutical companies.

In follow up correspondence the health professional noted the headline themes of the published article and that the BBC was aware that he/she did not want to be portrayed in this way. The health professional thought that the overseas meeting in question occurred in spring 2002 and was one of a series where consultants in pain were taken to New York. The hotel was on 7th Avenue and had no leisure facilities or restaurant. Visits were made to several New York hospitals. The trip lasted five days. Dinner was provided and the end of course dinner was held at the top of the Rockefeller Centre. Attendees could go to a Broadway show. A helicopter trip round Manhattan was also provided.

The detailed response from Napp is given below.

The Panel noted that the meeting appeared to have taken place in 2002. The requirements of the 2001 Code therefore applied. The Panel noted that as with all such cases the complaint including any supporting evidence had to establish the case on the balance of probabilities although the evidence provided by both parties would be taken into account. In this regard, the Panel noted Napp’s submission that its archive did not contain any original documentation in respect of certified materials and that relevant financial records were destroyed in 2013. Napp stated that it had to rely on the recollection of its one remaining employee who had some recollection of the programme. In this regard, the Panel noted that Napp was able to provide some details about the meeting. The health professional contacted by the Case Preparation Manager had also provided his/her recollection of the events in question. The Panel noted that it also had to bear in mind the Code standards and interpretation prevalent in 2002 in relation to meetings.

The Panel noted that the BBC article which formed part of the complaint referred to networking opportunities. One delegate named in the BBC article stated that the meeting was presented as an educational package, an opportunity to meet international thought leaders. The delegate now regretted attending stating that she/he was ‘a guinea pig to promote the prescribing of a class of drug’. The delegate in subsequent correspondence with the PMCPA explained that the trip was one of a series. He/she had met opioid thought leaders at New York hospitals and visited the headquarters of Purdue Pharma. The delegate described a ‘pleasant’ but apparently modest hotel with no leisure facilities or restaurant. He/she also recalled dinner at the top of the Rockefeller Centre, an invitation to attend a Broadway show, and a helicopter ride around Manhattan, all provided as part of the trip.

The Panel noted that according to Napp it understood that around 15 delegates who were all pain specialists would have attended. It stated that the primary purpose of the meeting was educational, to foster an exchange of ideas and clinical practice between US and UK pain specialists. The reason for taking the UK health professionals outside the UK was to enable UK health professionals to attend US pain clinics and see practical demonstrations of the delivery of pain services.

The Panel noted its comments about the evidential issues that arose given the meeting happened in approximately 2002 both in terms of recollection of events and retention of materials. Nonetheless, there was some common ground between the matters raised in the complaint and the account of the delegate and Napp’s submission.

The Panel considered that based on the limited evidence before it there did appear to be an educational element to the meeting. The Panel also noted in this regard that the complaint had to establish the case on the balance of probabilities and there was insufficient evidence before the Panel to establish whether the content of the meeting met the requirement of having a clear educational content or not as set out in the Code and no breach of the Code was ruled on that narrow point.

The Panel noted that the impression created by the arrangements was important and that delegates should be attracted by an educational programme rather than the fact that the meeting was held over 5 days in New York. Whilst accepting that modern digital ways of holding such meetings were not generally available in 2002 the Panel did not consider that it would have been considered acceptable in 2002 to take approximately 15 health professionals to New York for 5 days for what appeared to the Panel, on the limited information available, to be a company promotional meeting. The Panel noted its ruling above of no breach of the Code in relation to the educational content. Napp’s stated aim of fostering debate between UK and US based specialists and visiting local pain clinics did not, in the view of the Panel, of itself justify taking UK health professional outside of the UK for a 5 day stay in New York which might be viewed as an attractive tourist location and in this regard the Panel ruled a breach of the Code.

The Panel noted that whilst Napp stated that it was not aware of the helicopter tour mentioned by the delegate, in relation to the delegate’s recollection that he/she had been invited to a Broadway show Napp understood that tickets may have been arranged for one show during the trip. The Panel decided that given the parties’ similar evidence on this point, on the balance of probabilities, such tickets had been arranged. The Panel noted that hospitality must be secondary to the nature of the meeting and not out of proportion to the occasion. The Panel considered that in 2002 the provision of entertainment such as Broadway theatre tickets/trips would have been unacceptable under the requirements of the Code including the clause which prohibited the provision of gifts/ benefits in kind as an inducement. A breach of the Code was ruled.

High standards had not been maintained; a breach of the Code was ruled. The Panel noted its rulings above, particularly the impression given, and decided that in 2002, when the activities took place, they brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of Clause 2 was ruled.