The international watchdog for the drugs industry has published a report finding the drugs company GlaxoSmithKline guilty of misleading the public about one of its products. The finding followed complaints about claims made by a senior executive of the company on national American TV about the anti-depressant drug Seroxat (known as Paxil in the United States).

The complaint was raised by Charles Medawar of Social Audit, and has been legally supported on a pro bono basis by Anne Winyard of Leigh Day & Co. The company had given misleading information about the frequency of withdrawal problems - when patients stop taking Seroxat - and failed to respond to Social Audit's queries about the basis of its claims. The complaint was based on a breach of the industry's marketing code of conduct and sets an important precedent, requiring companies not to give misleading and incorrect information on TV and radio as well as in promotional material written by themselves.

Manufacturers admit Seroxat causes withdrawal symptoms

Seroxat has been available as a treatment for depression in the UK since 1991. Since its introduction, concern has been raised about sometimes severe withdrawal problems and the risk of dependence, in some patients attempting to come off the drug. For the first time, the manufacturers have admitted that withdrawal symptoms from Seroxat were frequently seen, even in short-term clinical trials. In December 2001 (after the November 2001 hearing of Social Audit's complaint, but before today's publication of the outcome) a new warning about withdrawal symptoms appeared on the US "label" (information sheet) for the drug. 

Anne Winyard, a partner in the specialist clinical negligence and personal injury firm, Leigh Day & Co, said:

'Though coming too late to help those already struggling with withdrawal problems, which might have been avoided, the ruling will help patients contemplating taking Seroxat and is a warning to the drug industry against ditching integrity in the interests of profit. Patients and doctors have a right to the facts about drugs in order to make the right treatment decisions. By denying patients valuable information about Seroxat, GlaxoSmithKline was failing to act ethically and accountably. The outcome of the complaint demonstrates the importance of self-regulatory bodies having to earn the respect of the public by cracking down on bad behaviour.'

Charles Medawar, of Social Audit said:

'Publication of the findings of the IFPMA are long over-due. Our complaint was raised over a year ago and even though the appeal body agreed their verdict in November 2001 it has taken two months to be published. Eventually, we got a good result, but if the public is to rely on self-regulation it must work much more efficiently than this.'

Notes 

1. As is usual practice, The International Federation of Pharmaceutical Manufacturers Association (IFPMA), delegated the hearing of the complaint to its relevant national committee - in this case the Association of the British Pharmaceutical Industry (ABPI). After an initial ruling in favour of GlaxoSmithKline in September 2001, an ABPI appeal body found the company to be in breach of the international marketing code of practice following a hearing on 15 November 2001. 

2. GlaxoSmithKline have been found guilty of breach of sections 1.3 and 1.7 of the IFPMA Code of Pharmaceutical Marketing Practices. S. 1.3 states that 'Information in promotional material should be based on an up-to-date evaluation of evidence that is scientifically valid and should not give an incorrect or misleading impression.' S. 1.7 states that 'Where it is permitted by law to communicate directly with patients regarding their prescription medicines, all such information should be accurate, fair and not misleading.'

3. The evidence from adverse reaction reporting systems, clinical trials and medical journals that Seroxat - among other SSRI antidepressants - causes withdrawal problems, has been reviewed comprehensively on the Social Audit website.