email dated 23 May 2001 from IFMPA

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
*********************************************
Dr. Eric Noehrenberg
Director, Intellectual Property and Trade Issues, IFPMA

reply:

Social Audit Ltd

P O Box 111 London NW1 8XG

Telephone/Fax 44 (0)207 586 7771

 

Dr. Eric Noehrenberg
Director,  Intellectual Property and Trade Issues, IFPMA
IFPMA, P O Box 758
30 rue de St.-Jean
1211 Geneva 13, Switzerland	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

	Contents page
	What's New?