AUTH/2118/4/08 - Lifeblood: The Thrombosis Charity v Boehringer Ingelheim

Press release re launch of Pradaxa

  • Received
    25 April 2008
  • Case number
    AUTH/2118/4/08
  • Applicable Code year
    2006
  • Completed
    27 June 2008
  • Breach Clause(s)
    11.2, 11.3 and 20.2
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    August 2008

Case Summary

Lifeblood: The Thrombosis Charity complained about a press release about Pradaxa (dabigatran etexilate) which it stated had been issued by a media advisor acting for Boehringer Ingelheim.

Lifeblood stated that the press release appeared to have come from it. Lifeblood did not, nor would it, its trustees or its medical director, ever issue any press release which endorsed or appeared to endorse a specific product.

In other press releases concerning Pradaxa, Lifeblood discussed the area generally and did not endorse the product directly.

It was the policy of Lifeblood to remain independent. When there were advances in the prevention and treatment of thromboembolic disease, the trustees including the medical director took great care not to give specific endorsements. Any statements sought from the trustees, or the medical director, were deliberately couched in neutral terms to welcome the advance but not to endorse the product. No payment was accepted for participating in any press releases, and all releases were vetted to ensure that the neutrality was preserved. Lifeblood, and in particular its medical director, were not given sight of the press release in question, the opportunity to comment on its content or asked for consent to publish the press release.

Three trustees of Lifeblood were health professionals who were active on the National Institute for Health and Clinical Excellence (NICE) committees. NICE was in the midst of determining what the NHS best practice should be in this field.

The impartiality of those trustees, and of Lifeblood, was of paramount importance, for without it the charity's credibility as a lobbying force, and any research it commissioned would be tainted. This was of particular concern when dealing with any of the multinational pharmaceutical companies which were competitively and aggressively pursuing an alternative to warfarin.

Lifeblood's medical director was invited by Boehringer Ingelheim to participate in media interviews, the day that Pradaxa (the new oral anticoagulant) was launched in April 2008. Boehringer Ingelheim was fully aware of the necessity for Lifeblood to remain impartial.

Boehringer Ingelheim offered to pay Lifeblood and its medical director for the time she spent participating in media interviews, but this was declined.

The press release at issue had placed Lifeblood in a very difficult position, for it compromised its apparent integrity and impartiality. Reputation and trust were very hard won, and very easy to lose. In this instance the irresponsible publication of an unauthorised press release had placed its reputation in jeopardy.

This press release was not known about, or sanctioned, by Lifeblood. Its content was completely unacceptable and appeared designed to cynically manipulate public opinion and market forces – at the expense of Lifeblood and its medical director – for the benefit of those promoting Pradaxa.

The Panel noted that it was a clearly established principle under the Code that a company was responsible for the actions of third parties employed on the company's behalf even if that third party acted outside the instructions from the pharmaceutical company.

The Panel considered that Boehringer Ingelheim had been very badly let down by a subcontractor to its agency who had not followed the agreed procedures regarding prior approval of material. This was of serious concern. The agency had subcontracted the media advisor. Neither the agency nor Boehringer Ingelheim knew why the approved press release had been amended without reference or approval from either the agency or Boehringer Ingelheim.

The effect of the actions of the consultant to the agency were extemely serious. Quotations were used in an inappropriate manner ie the quotations did not reflect the meaning of the author and formal permission had not been obtained. Thus the Panel ruled breaches of the Code. The Panel also considered that the quotation attributed to Lifeblood's medical director was not in line with the authorized indications for Pradaxa as it did not state that it was for use after elective surgery; the material was thus misleading and inaccurate in this regard. A breach of the Code was ruled.

The Panel considered that it was particularly important when working with third parties such as patient organisations that all materials were in accordance with the Code. This was even more important when working on a new product as all such materials had to be prevetted by the Medicines and Healthcare Products Regulatory Agency (MHRA).

The Panel noted the circumstances of this case. Boehringer Ingelheim had a procedure for approving press releases and its contract with the agency stated that material had to be submitted to the company for written approval before release. The contract further stated that the agency should comply with all codes of practice. According to Boehringer Ingelheim's submission the agency had used an experienced subcontractor, trained on the Code, who had acted entirely outside the contract and without the knowledge of either the agency or Boehringer Ingelheim. It was difficult to see what more Boehringer Ingelheim could have done. The Panel considered that as Boehringer Ingelheim had procedures and processes in place to ensure compliance with the Code and had been so very badly let down by a third party there was no breach in relation to the requirements to maintain high standards and not to bring discredit upon the pharmaceutical industry.