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| 14th August 2001 | ||||
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| UB11 1BT | ||||
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Mrs Heather Simmonds
Code of Practice Authority
12 Whitehall
London SW1A 2DY.
Our Ref: yg/012/baa
Dear Mrs SimmondsCase AUTH/IFPMA/5/7/01: Statements about Seroxat (IFPMA Reference: C2001/21j
We acknowledge receipt on 16 July 2001 of a complaint made by Mr Charles Medawar on 26 December 2000 to the IFPMA. The complaint was referred by the IFPMA to the ABPI in the UK and copied to PhRMA in the US. The complaint related to comments made by, or attributed to, Dr David Wheadon an employee of SmithKline Beecham (now part of the GlaxoSmithKline group) who had been asked by the broadcaster to take part in a US television programme. The subject matter of ABC-TV's "20-20" programme concerned adverse events claimed to be attributable to antidepressants, mainly Paxil (paroxetine).
By this response we wish to contest the complaint.
First, it is our view that the IFPMA Code of Pharmaceutical Marketing Practices is not intended to cover the situation in which Dr Wheadon found himself. The Code is clearly intended to ensure good practice in the marketing or promotion of pharmaceutical products. lndeed, the lFPMA Code is specifically known as the IFPMA Code of Pharmaceutical Marketing Practices. Dr Wheadon agreed to be interviewed at the request of the broadcaster in order to respond to claims regarding adverse events, and his participation clearly did not constitute marketing or promotional activity of any kind. He was merely responding to questions put to him. The IFPMA's letter of 13 July 2001 refers to Sections 1.3 and 1.7 as the "relevant sections of the Code". We believe the suggested application of these sections in this way is not appropriate, as the sections are being taken out of context from the intended scope and purpose of the Code, which is to cover marketing and promotional activities and not the invited participation in a television news magazine, to respond to charges against a product.
In addition, Mr Medawar had complained about information presented on a television news magazine programme over which SmithKline Beecham (SB) had no editorial control. Although ABC-TV interviewed Dr Wheadon for the "20/20"programme, at their request, the company (SB) did not collaborate or suggest to ABC-TV what subjects should be discussed with Dr Wheadon or how they should be discussed. Indeed, Dr Snyderman interviewed Dr Wheadon for more than one hour, yet ABC-TV chose to air less than three minutes of that interview, which was inserted at points within the programme. As SB has not been provided with a full transcript of the entire 75-minute interview, it has been unable to respond adequately to Mr Medawar's challenge to statements that ABC-TV's programme attributed to Dr Wheadon. The complainant challenged the following statements by Dr Wheadon and ABC-TV's Dr Snyderman, which from the context presumably referred to "discontinuation syndrome":
"Dr David Wheadon: What we have seen in terms of the anecdotal reports is that it happens very rarely.
Nancy Snyderman: (Voice Over) Dr David Wheadon is Vice President of Regulatory Affairs at SmithKline Beecham, the maker of Paxil. He says withdrawal, or as SmithKline Beecham prefers to call it, discontinuation syndrome, occurs in only 2 out of every 1 000 patients who are discontinued appropriately. Even then he says the symptoms are mild and short-lived.
As discussed above, most of the statements at issue were attributed to Dr Wheadon by Dr Snyderman. He did not make these statements during the "20/20" programme, and SB did not have any editorial control over the statements and the context in which they were used.
Regardless, the relevant statements in the programme are not inaccurate.
With respect to discontinuation syndrome or withdrawal syndrome, as Dr Snyderman herself acknowledged, the United States Product Information lists withdrawal syndrome" as a rare event, observed and reported during the premarketing evaluation of paroxetine. As set forth in the Product information, this is an accurate statement of the pre-marketing data as reported by investigators. Indeed the cumulative adverse experience data from the company clinical trial database for paroxetine, which contains information from studies across all current treatment indications, shows that investigators reported "withdrawal syndrome" in 7 of 8413 patients. SB also received reports of individual symptoms in connection with discontinuation of treatment in clinical trials. However, the segment of Dr Wheadon's interview broadcast by ABC related to what the persons reporting the events described as a syndrome, and not as individual symptoms.
With regard to the frequency of anecdotal reports, as Dr Wheadon stated, they have been very rare relative to the number of patient-treatments with paroxetine. SB has reviewed its clinical safety database on several occasions since 1991, the year paroxetine was launched, for reports of withdrawal/discontinuation syndrome or symptoms. The reviews have consistently supported the statements made by or attributed to Dr Wheadon on "20/20" regarding paroxetine. SB's review, conducted in mid-2000 and prior to the airing of the ABC-TV programme, examined reports entered into the system between February 1991 and 14 September 1999. SB received 1573 patient reports of withdrawal/discontinuation syndrome or symptoms and 1161 reports of adverse experiences post-treatment. The number of reports is very small relative to the approximately 70 million patient-treatments estimated to have occurred from the launch of paroxetine to the time of analysis. The fact that symptoms have been reported does not establish a causal connection to a medicine.
Therefore the figures attributed to Dr Wheadon are very reasonable in the context of the reports available to SB in its clinical trials database and its clinical safety database.
With respect to ABC-TV's Dr Snyderman's description of the symptoms as mild and short-lived", the US Product Information for Paxil uses the term generally self-limiting".
The Committee for Proprietary Medicinal Products (CPMP), in Europe, recently reviewed the issue of discontinuation symptoms in patients receiving medicines in the category of Selective Serotonin Reuptake Inhibitors (SSRIs). They recommended that the Summary of Product Characteristics for SSRIs contain the language: "majority of withdrawal reactions are mild and self-limiting".
Moreover, the data from the clinical trial programmes have shown that the adverse experiences reported following cessation of paroxetine are generally mild to moderate in severity. The majority of symptoms resolved themselves within two weeks and there was only a minimal requirement for corrective therapy to treat symptoms that may be associated with discontinuation of paroxetine treatment. Review of the post-marketing experience confirmed that the vast majority of reported events were mild to moderate in severity and were of a non-serious nature, as defined by regulatory authorities.
In summary, we consider that the IFPMA Code was not intended to cover this situation. Regardless, we believe that Dr Wheadon's statements and those attributed to him are supported by the available data and are not in breach of Sections 1.3 and 1.7 of the IFPMA Code.
We provide six copies of the United States Product Information for Paxil and of the CPMP Position Paper on SSRIs and Dependency/Withdrawal Reactions.
Yours sincerely
Eddie Gray
General Manager & Senior Vice President
