Social Audit Ltd
P O Box 111 London NW1 8XG
Telephone/Fax 44 (0)207 586 7771

 

Dr Odette Morin Carpentier
Director of Regulatory and Scientific Affairs
Code of Practice Committee
IFPMA, P O Box 758
30 rue de St.-Jean
1211 Geneva 13, Switzerland 26 December 2000

Dear Dr Carpentier,

Section 1.7 of the IFPMA Code, also sections 6 and 8 of the Ethical criteria for medicinal drug promotion (WHO, 1998), suggest you may be able to help in the following case.

Last Summer, Dr David Wheadon, a senior executive in SmithKline Beecham Pharmaceuticals (USA) broadcast claims for the safety of paroxetine on a popular, nation-wide documentary programme about the problems some people had when coming off SSRI antidepressants ('A painful withdrawal', 25 August, 2000, ABC-TV, '20-20'). I wrote to Dr Wheadon, perhaps rather too politely, but making it clear that there were many reasons to think his remarks were neither scientifically nor ethically supportable. I gave evidence that the risk of withdrawal symptoms and 'therapeutic dependence' on paroxetine might be far greater than the company suggests and asked for their evidence in turn. I gave the company every opportunity to explain its position and the context of those remarks. I wrote to and faxed Dr. Wheadon twice but received no reply. I enclose copies of those letters.

Please would you let me know if your code would cover such a complaint? If so, I would want to consider making one. I am in some doubt because this claim was made on a TV program, under the editorial control of ABC-TV. However, section 1.7 of the IFPMA Code says that "all" communications to the public should be accurate, fair and not misleading, and the WHO ethical criteria say that promotion "refers to all information and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and or/or use of medicinal drugs". Both Codes emphasise the requirement to substantiate claims made.

If your code does not cover this complaint, perhaps you (or someone else in the IFPMA) would be kind enough to advise me about how to proceed in such circumstances? Is this sort of conduct thought generally acceptable in the pharmaceutical industry? This is surely a question for the IFPMA rather than ABC-TV.

I have placed this letter on our website and shall be pleased to post your reply in due course. Many thanks for your help and attention.

Yours sincerely,
Charles Medawar

              
By email, 23 January 2001
Dear Dr Carpentier,
I wrote to you by email and mail nearly a month ago
to ask about the scope of the IFPMA Code, and to
establish whether or not it would be possible to make
a complaint about SmithKline Beecham Pharmaceuticals
(USA). The basis of my enquiry was explained in the
correspondence with that company which I attached.
I should be grateful for a reply and look forward to
hearing from you.
Yours sincerely,

By email, 8 February 2001
Dear Ms Krause,
Further to our telephone conversation this morning, I am
now resending this email originally addressed to Dr Morin-
Carpentier, which I also sent by post. I am also re-sending
a copy of my follow-up request dated 23 January. I should
be grateful for a response in the near future.
Sincerely,

By email, 8 February 2001
Dear Dr. Medawar,
This is just to let you know that I received your mails,
and I forwarded your mails to Dr. Eric Noehrenberg
who will be taking care of your request.
Dr. Eric Noehrenberg
Tel. 41-22-338-3208
e-mail: e.noehrenberg@ifpma.org

By email, 4 April 2001
Dear Dr Noehrenberg,
I am repeating the request I made one month ago
(see below) requesting a response to the letter I
wrote at the end of last year. If you do not intend
to reply, it would be a courtesy to let me know,
since the mail I had from your colleague, Ryoko
Krause (8 February) clearly implied I could expect
to hear from you. I shall wait one week longer;
thereafter I shall not trouble you again.
Sincerely,

By email, 5 April 2001
Dear Mr Medawar,
Thank you for your e-mails and for your patience.
I regret the delay in responding to you - I have only
recently taken on the responsibilty for questions
concerning the IFPMA Code and, with the past
couple of months being very busy with travel and
conferences, I have been delayed in addressing this area.
My apologies for that and I will review your concerns
shortly in order to revert to you regarding them.
In the interim, now that the merger between SmithKline
Beecham and GlaxoWellcome has been completed,
your office may want to check with the new GlaxoSmithKline
regarding your past inquiries to SmithKline Beecham
Pharmaceuticals. Thank you for your understanding
and I will come back to you in the near future.
Yours sincerely, Dr. Eric Noehrenberg

By email, 6 April 2001
Dear Dr Noehrenberg,
Thank you for your mail. I appreciate your problems
and will hang on for a week or so. I am not inclined
to approach GSK over this. Beyond the substantive
point - about the safety and effectiveness of drug
treatment - there are important points of underlying
principle which I think it is for the IFPMA to address.
I look forward to hearing from you in the near future.
Sincerely,

By email, 23 May 2001
Dear Mr Medewar,
Thank you again for your patience and for your query
concerning the television program in question. In order for
us to make any judgement in this matter, it would be
necessary for us to review a transcript of the program to
see what statements were made. Also, please confirm that the
letters which you sent to GlaxoWellcome at the time
constitute a formal complaint to the firm regarding this matter.

Yours sincerely,
Dr. Eric Noehrenberg

By letter, 25 May 2001
Dear Dr Noehrenberg,
I would call it amused exasperation rather than patience but,
whatever it is, this correspondence is proving most rewarding
as a research exercise into the nature of the dependence risk
with paroxetine and standards of accountability in the international
pharmaceutical industry. My enquiries to SmithKline Beecham date
from 9 months ago and we’re just coming up to the 6-month mark
with the IFPMA. These long delays, refusals to answer and evident
lack of concern are surely relevant measures of the risks.

It seems to me extraordinary that you should now be coming back to
ask if I made a formal complaint to SmithKline Beecham, at it then was.
I sent you the letters I wrote to the company, some months ago.
You will see I did not complain: as I said, I was politely asking the
company to substantiate a major claim it made for the safety of paroxetine.
Having analysed many reports on this drug, over the years, I believed
the company’s claim to be unwarranted and misleading. I am waiting
to be convinced otherwise. In the meantime, I will write a formal letter
of complaint, if this would help to satisfy the requirements of your
bureaucracy and/or otherwise expedite this process. Do, please, let
me know. Perhaps you could also direct me to the provision of the
IFPMA Code which specifies that is what I should have done.
I see no reference to it in Annex B under Use of the Complaints Procedure.

I am enclosing a full copy of the transcript you requested and the
passage that prompted my original enquiries to SKB and the IFPMA:

DR DAVID WHEADON What we have seen in terms of the
anecdotal reports is that it happens very rarely.

NANCY SNYDERMAN (VO) 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. What do you mean
by discontinued appropriately?

You will appreciate that my enquiry to the IFPMA relates also to
non-disclosure, whether or not the claim was misleading. Our position
is set out in the note on Integrity in Drug Promotion on our website at http://www.socialaudit.org.uk/5016-SKB.htm#INTEGRITY

You will see from this that paroxetine is the top of the list of drugs for
which withdrawal symptoms indicative of dependence have been reported
to the WHO/Uppsala Monitoring Centre. There are more reports for
paroxetine than for the top five benzodiazepines combined. Was it
unreasonable to ask SKB if these reactions were in fact mild, short-lived
and very rare?

DRUGS FOR WHICH WITHDRAWAL/DEPENDENCE PROBLEMS HAVE BEEN REPORTED MOST
          SOURCE: UPPSALA MONITORING CENTRE, JANUARY 2001

DRUG NAME

REPORTS

Paroxetine

2003

Venlafaxine

1058

Alprazolam

842

Sertraline

585

Hyoscine

519

Fenfluramine

450

Fluoxetine

402

Tramadol

389

Phentermine

371

Methadone

316

Lorazepam

282

Dexfenfluramine

277

Diazepam

192

Triazolam

188

Clonazepam

112

I hope this further information will be useful and look forward to hearing from you

Yours sincerely,
Charles Medawar

By email, 12 July 2001
Dear Dr Noehrenberg,
Over six months have passed since I first wrote to the
IFPMA, to ask about using your Code of Marketing
Practice, and six weeks have elapsed since I provided
you with the transcript of the ABC-TV prgramme you
requested. I am now writing to ask if you have made
any progress in investigating my complaint and, if so,
when I might expect to hear from you? I should be grateful
for an update. Thank you for your attention; I look forward
to hearing from you.
Sincerely,

By email, 13 July 2001
Dear Mr Medewer:
Thank you for your note. We are in contact with the ABPI
(as the headquarters of SB was in the UK) and also with the
management of GSK, as a successor to SB, regarding the
matter which you have brought to our attention. I have
forwarded the materials which you kindly sent to us to these
organizations and I am following up by telephone as well.
My apologies for the delay in responding to you; I will certainly
get back to you with feedback regarding the matter in question
as soon as possible. Thank you for your understanding.
Yours sincerely,
Dr Eric Noehrenberg

By fax and mail, 12 July 2001

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 (original by mail)

Social Audit

+44 207 586 77 71

PO Box 111
London NW l 8G   UK

13 July 2001

 Dear Mr. Medewar, 

IFPMA CODE OF PHARMACEUTICAL MARKETING PRACTICES
Code Complaint, Reference C2001/01

Thank you for your last e-mail dated 12 July 2001 referring to the TV broadcast in the US concerning Paxil on 25 August 2000. We also would like to apologize for the delay in responding to you.

We are proceeding to deal with the matter formally in accordance with the IFPMA Code complaints procedure, under the reference shown above. The matter will be dealt with as quickly as possible and we shall advise you as soon as a conclusion has been reached.

Thank you for drawing this to our attention for action under our self-regulatory Code.

Yours sincerely,

Dr Harvey E. Bale, Jr.
Director General, IFPMA

 


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