UK medical profession drug ad watchdog the Prescription Medicines Code of Practice Authority investigated advertising to doctors of AstraZeneca’s blockbuster anti-psychotic drug, Seroquel and focused on how side effects were dealt with. Jonathan Mayner diagnoses the outcome.
Topic: Health & Beauty
Who: AstraZeneca / Prescription Medicines Code of Practice Authority
When: March 2010
Where: UK
Law stated as at: 22 March 2010
What happened:
On 9 March 2010 AstraZeneca ("AZ"), the Anglo-Swedish pharmaceuticals manufacturer, was found in breach of industry marketing rules by failing to accurately reflect the side effects of its blockbuster drug Seroquel in advertisements to doctors.
Seroquel is one of the top ten best-selling drugs in the world. It has been on the market since 1997 and generated sales in the region of $4.87 billion in 2009 for AZ.
Regulation of medicines marketing in the UK
While the Advertising Standards Authority does have some scope to investigate the advertisement of medicines, such matters are usually dealt with by industry-specific regulators.
The Medicines and Healthcare Products Regulatory Agency (the "MHRA") is empowered by statute to regulate the pharmaceuticals industry, including the marketing of medicines and healthcare products. The industry is however heavily geared towards self-regulation and a significant proportion of complaints about the marketing of medicines and healthcare products are dealt with by industry bodies under voluntary codes of practice.
Over-the-counter products can be marketed to consumers directly and such advertisements are regulated by the Proprietary Association of Great Britain. Marketing for prescription medicines must only be targeted to healthcare professionals in the UK (unlike the position in the US) and is regulated under a Code of Practice (the "ABPI Code") drafted by The Association of the British Pharmaceutical Industry drafted and administered at arms' length by the Prescription Medicines Code of Practice Authority (the "PMCPA").
The Seroquel advertisement
AZ placed an advertisement in the British Journal of Psychiatry in July 2004 which claimed that Seroquel has a favourable weight gain profile when compared with rival anti-psychotic drugs. The small print in the advertisement contained a statement that weight gain was a common side-effect.
The PMCPA reportedly received three separate complaints about this advertisement in January 2009: one from a healthcare professional, one from a journalist, and one from a member of the public. The PMCPA website currently shows two complaints being considered: one from an ex-employee, and one from a member of the public.
The Breaches
Details of the case have not been forthcoming from the PMCPA, even after the deadline for appeals (13 March) had passed. However it has been reported that AZ will not be appealing the decision and details of the breaches have emerged on various online news sites and industry blogs. It has been reported that the advertisement breached three provisions of the ABPI Code relating to information and one provision relating to standards, specifically:
• 7.2 – Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly. They must not mislead either directly or by implication, by distortion, exaggeration or undue emphasis;
• 7.4 – Any information, claim or comparison must be capable of substantiation;
• 7.9 – Information and claims about side effects must reflect available evidence or be capable of substantiation by clinical experience; and
• 9.1 – High standards must be maintained at all times.
AZ cited two scientific studies in its defence which looked at weight gain and the use of anti-psychotic drugs. The company also said that the healthcare professionals to whom the advertisement was targeted would have understood the claim made in the advertisement in the context of the debate around weight gain and anti-psychotics and in the context of available clinical evidence at the time.
But the PMCPA highlighted shortcomings in the studies and ruled that the advertisement was misleading because it did not accurately reflect the available evidence.
Why this matters:
The case is a reminder to all manufacturers of prescription drugs that even when advertising to healthcare professionals they have obligations under the ABPI Code to represent their products accurately and fairly, to only make claims which are capable of substantiation, and to maintain high standards at all times. Reliance on the expertise and knowledge of the target audience to supplement claims made in advertising may receive short shrift from the industry's regulators.
