Department of Health
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 020 7 273 0267    Room 13-202
Facsimile 020 7 273 0109 .
12 October 2000

Dear Mr Medawar,

EFEXOR ADVERTISEMENT - BMJ (Classified) 27 November 1999

Further to Mrs Duddy's letter of 27 March 2000, I am writing to inform you that we have investigated this issue and am now able to reply in full.

We have reconsidered the advertisement in the light of your comments and have undertaken a review of all the relevant data.

You may be interested to know that, as a result of our investigations and correspondence with the Marketing Authorisation Holder, the above advertisement has been amended. Future advertisements will now state "Efexor XL, the world's first SNRI, is significantly more effective than fluoxetine in eradicating the symptoms of depression". With regard to the concerns raised in your letter of 15 March 2000, we would like to make the following comments:

1 . You, quite rightly, point out that all advertisements relating to relevant medicinal products must comply with the SPC. Whilst this is a requirement of the Advertising Regulations, you will also be aware that promotional material may also contain particulars that are supported by data and references. Additional particulars, which are not required to be included in the SPC, may be included in advertising provided they are capable of substantiation on request and do not breach any other provision of the Advertising Regulations. Claims of comparative efficacy could fall to be considered in this respect.

2. Although we agree that the claim of superior efficacy may be taken at face value, it does not necessarily imply that the product would be suitable as a first line therapy. Major factors such as the overall risk benefit of the drug, cost effectiveness and individual patient's condition and history would have to be taken into consideration by the prescriber. Furthermore, the dosage and duration of the treatment should remain the decision and responsibility of the prescriber who would have to take into account the individual needs of the patient.

3. In the pivotal study by Rudolph et al, the mean daily dose (MDD) for patients on Venlafaxine was 174mg, compared with a NMD of 47mg for patients on fluoxetine, i.e. within the licensed upper dose range for both drugs. The amended advertisement for venlafaxine no longer claims superior efficacy at the lower dose of 75mg od.

4. The consensus in the professional literature is that venlafaxine at a dose of 150mg or greater, may be more effective than SSRIs for major depression of at least moderate severity. You may wish to address further correspondence regarding this matter to the Journal of Psychopharmacology.

5 . The relationship between endpoint Hamilton depression score and number of adverse events after treatment discontinuation is not directly relevant to the advertising claim, although it may affect clinical practice.

6. The Advertising Regulations require that no advertisement should be misleading. In our view, an advertisement can be considered to be in breach of Regulation 3A(3), where the overall impression or "take out" of the advertisement is misleading in some respect, but the particulars given are not false. An example of this would be where the advertisement misleads as to any restrictions on use and so does not present the product objectively.

I hope that I have addressed your concerns. I can assure you that the MCA take all complaints relating to the advertisements of medicinal products seriously and consider it our responsibility to investigate them fully to a satisfactory conclusion.

Please accept my apologies for the delay in responding and I would like to thank you for bringing this matter to our attention.

Yours sincerely
Head, Product Information & Advertising
Post-Licensing Division
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