An anonymous, uncontactable complainant alleged that incorrect information had been given by an AstraZeneca representative during the course of promoting Symbicort Turbohaler (budesonide plus formoterol). Symbicort was indicated in the regular treatment of asthma where the use of a combined inhaled corticosteroid and long-acting beta2-agonist was appropriate.
The complainant noted that the representative stated that a pressurised metered dose inhaler (pMDI), with good technique, delivered only 10-15% of the dose to the lungs compared with 30% achieved with the Turbohaler. The impression given was that the Turbohaler always achieved better lung deposition than an MDI. A leavepiece, entitled 'Clinically Effective Inspiratory Flow', stated: 'Turbohaler is effective at a peak inspiratory flow (PIF) of around 30L/min, delivering 15% of dose to the lung (a pressurised MDI, with good inhalation technique, delivers 10 -15%).' and 'Doubling the PIF to 60L/min increases the lung deposition to about 30%'.
The complainant looked into the matter and noted that lung deposition with MDIs containing ciclesonide was over 50% and with beclometasone was either 36% or 52%, depending on whether the MDI was Clenil or Qvar. Consequently, the complainant was very cautious about the information provided by AstraZeneca and its representative.
The detailed response from AstraZeneca is given below.
The Panel noted AstraZeneca's submission that the bracketed part of the claim 'Turbohaler is effective at a peak inspiratory flow (PIF) of around 30L/min, delivering ~15% of nominal dose to the lung (a pressurised MDI, with good inhalation technique, delivers 10-15%)' was true for the majority of pMDIs used in the UK but not for Alvesco, Clenil and Qvar. The claim, however, was not qualified, it appeared that no pMDI delivered more than 10-15% of the nominal dose which was not so; Alvesco delivered over 50%, Clenil 36% and Qvar 52%.
The Panel did not accept AstraZeneca's submission that, taken in its entirety, health professionals would understand the claim to mean that at a PIF of around 30L/min the amount of medicine delivered to the lung by a Symbicort Turbohaler was comparable to that of the more common pMDIs. It appeared that at a PIF of around 30L/min the dose delivered from the Turbohaler was comparable to that delivered by all pMDIs which was not so. The Panel considered that the claim as a whole presented a misleading comparison which could not be substantiated. Breaches of the Code were ruled.
The Panel noted that the claim 'Doubling the PIF to 60L/min increases lung deposition to about 30%' was true for the Turbohaler. However, given the context in which it appeared ie immediately below the comparative claim discussed above, it appeared that at a PIF of 60L/min lung deposition with a Turbohaler would be better than with all pMDIs which was not so. Breaches of the Code were ruled.
The Panel noted its rulings above and considered that high standards had not been maintained. A breach of the Code was ruled which was upheld on appeal by AstraZeneca.
The Panel noted that the complainant alleged that the representative had stated that a pMDI with good technique delivered only 10-15% of the dose to the lungs compared with 30% achieved with the Turbohaler. The Panel considered that it was difficult to know what had been said between the parties; a judgement had to be made on the available evidence. The complainant was anonymous and non-contactable and had not identified the representative. The Panel considered that the statement allegedly made by the representative was misleading. Nonetheless, it was based on the claims in the leavepiece and, in that regard, the representative was only following his/her brief. The Panel considered that the matter was covered by its rulings of breaches of the Code above and thus the Panel ruled no breach of the Code.
http://www.pmcpa.org.uk/files/2320%2028%20September.pdf
No comments:
Post a Comment