IFPMA-LOGO-NEW.bmp (1178 bytes) International Federation of Pharmaceutical Manufacturers Associations
Fédération lnternationale de I'Industrie du Médicament
Federación lnternacional de la Industria del Medicamento
Mr. Charles Medewar

By telefax

Social Audit

+44 207 586 7771

PO Box 111
London NW l 8G   UK

21 January 2002

 

Dear Mr. Medewar, 

IFPMA Code Complaint
Ref: C2001/01

I refer to your complaint, dated 26 December 2000, made under the IFPMA Code.

This complaint, which cited a case involving statements concerning Paxil has now been dealt with under the procedures set out in the IFPMA Code. A breach of section 1.3 and 1.7 of the IFPMA Code have been determined in this case, and a report on the outcome is attached.

In accordance with the agreed procedures, we are making a public announcement of these breaches of the Code.

I hope you agree that this matter has now been satisfactorily resolved.

Yours  sincerely,
           Dr. Harvey E. Bale, Jr.
Director-General

 

cc: Mr. J.P. Gamier, GlaxoSmithKline
Mr. A. Holmer, PhRMA
Mr .E. Gray, GlaxoSmithKIine
Mrs. H. Simmonds, Prescription Medicines, Code of Practice Authority

    


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E-mail: admin@ifpma.org      IFPMA Web site: http://www.ifpma.org

 

IFPMA-LOGO-NEW.bmp (1178 bytes) International Federation of Pharmaceutical Manufacturers Associations
Fédération lnternationale de I'Industrie du Médicament
Federación lnternacional de la Industria del Medicamento
IFPMA CODE OF PHARMACEUTICAL MARKETING PRACTICES
Code Complaint, Reference C2001/l
REPORT OF A BREACH OF THE CODE

Product:                 PAXIL (Paroxetine)

Company:                 GlaxoSmithK1ine

Complaint from:          Mr Charles Medewar
                                        Social Audit

Date Received:         26 December 2000

Source of Complaint: Broadcast in ABC- TV in the US in the program "A Painful                                           Withdrawal"

Date:                         25 August 2000

 

Summary
The basis for the complaint about the statements made by a representative of GlaxoWellcome (as the company was then known) in the program "A Painful Withdrawal" (ABC-1V) was as follows:

1. The representative of GlaxoWellcome stated while being interviewed in the program that "What we have seen in terms of the anecdotal reports [of withdrawal] is that it happens very rarely". In a voiceover, GlaxoWellcome's representative was reported as also having said that withdrawal or discontinuation syndrome " ...occurs in only 2 out of every 1,000 patients who are discontinued appropriately. Even then the symptoms are mild and short-lived." The complainant alleged that the scientific evidence did not support these claims and that these claims were made in promotional material. He furthermore noted that the company did not respond to his requests for information concerning these statements. The allegation has therefore been reviewed with reference to Section 1.3 of the Code (see below).

2. Furthermore, the statements in question were made in a television program accessible to the general public. Thus, the complainant alleged that the purportedly inaccurate statements made in the program were made directly to the public. This allegation has been reviewed with reference to Section 1.7 of the Code.

Process The headquarters of GlaxoSmithKline being in the UK, this complaint was referred to IFPMA's UK Member Association, ABPI, and dealt with by the Prescription Medicines Code of Practice Authority (PMCPA). As the Code of Practice Panel ruled that there was no breach of the IFPMA Code, the complainant appealed this decision to the Code of Practice Appeal Board. The Appeal Board has given the following opinion:

 Opinion

1. The Appeal Board noted that "promotional material" included more than just printed promotional material. In the television broadcast in question, although GlaxoSmithKline had not positively promoted its product, a company employee had appeared to defend the product which was in itself a form of promotion. The Appeal Board concluded that Section 1.3 of the IFPMA Code did apply in this case. The Board then cited the explanatory notes to Section 1.3 which state, inter alia that "Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the enquiry." The Appeal Board considered that GlaxoSmithK1ine's failure to respond to Social Audit's request for information was a breach of Section 1.3 of the IFPMA Code.

2. The Appeal Board noted that in the interview the representative of GlaxoWellcome stated, with reference to discontinuation syndrome, that what had been seen in terms of anecdotal reports was that it happened very rarely. The Appeal Board recognized that even a balanced and fair interview could be could be made to appear imbalanced, unfair and misleading by selective quotation. However, the Appeal Board noted that the spontaneous reporting rates of withdrawal/discontinuation syndrome did not necessarily equate with the incidence of the effect. The US product information described the frequency of withdrawal syndrome as a rare event, not very rare as stated by the representative of GlaxoWellcome. The Board therefore concluded that the statement made by the representative of GlaxoWellcome was misleading and in breach of Section 1,3 of the IFPMA Code.

3. The Appeal Board concluded that the statements made by the representative of GlaxoWellcome can be considered as having been made directly to the public, thus covered by Section 1-7 of the IFPMA Code. As the statement made by the representative of GlaxoWellcome was considered to be misleading and having been made directly to the public, it is also in breach of Section 1.7 of the IFPMA Code.

Outcome of the IFPMA Complaint
The IFPMA Secretariat agrees with the opinion of the UK Code of Practice Appeal Board. GlaxoSmithKline has been found to be in breach of Sections 1.3 and 1.7 of the IFPMA Code. The company has accepted this decision and has given assurance that they will take all possible steps to avoid similar breaches of the IFPMA Code occurring in the future.

Relevant Sections of the Code

I.3. Scientific Evidence
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. Prescribing information should be supported by this information and be in accordance with the local product authorisation or, where this is not applicable, should be in accordance with an authorisation issued by a regulatory authority in an industrialised country. Scientific data to support the claims and recommendations for use should be made available, on request, to healthcare providers.

Excerpt from Explanatory Note to Section I.3
Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the enquiry.

I.7. Communications to the Public
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.

Where companies assist in the conduct of public/patient disease awareness programmes to meet growing demands of society for more information and enhance public understanding of disease prevention, signs and symptoms of medical conditions, illnesses, and available treatments, such activities should adhere to the highest standards of accuracy and support the role of the health care provider.

            

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