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Healthy Skepticism International News

May 2004

Correspondence about the launch of Bristol-Myers Squibb’s agency in Sri Lanka.

Abstract:

This issue consists of the correspondence between Prof Weerasuriya and Bristol-Myers Squibb after Prof Weerasuriya, then Professor of Pharmacology & Secretary, Drug Evaluation Sub-committee, Ministry of Health Sri Lanka noted that a significant number of banners displayed by Bristol-Myers Squibb at the launching of their agency in Sri Lanka violated regulations on pharmaceutical promotion in Sri Lanka, the regulations of the US FDA and the Code of Practice of the International Federation of Pharmaceutical Manufacturers Association.
18 May 2000

Mr Shaun E. Donnelly, Ambassador
The American Embassy
210 Galle Road,
P. O. Box 106
Colombo 3.

Dear Mr Donnelly,

LAUNCHING OF BRISTOL-MYERS SQUIBB AGENCY IN SRI LANKA – 30TH APRIL 2000 AT THE HILTON

I was present at the invitation of Walker & Greig at the launching of the Bristol-Myers Squibb (BMS) agency in Sri Lanka. The proceedings did go on for some time but your short and clear words were greatly appreciated as most were waiting for their dinner! BMS did project their company well and stressed the fact they have a responsibility towards patients, their employees and society in general. However this is to bring to your notice a rather significant lapse of what BMS aspires to do, and that you as the representative of the US government was also inadvertently associated with it.

The hall at the Hilton was hung with many banners advertising the products of BMS as would be expected at a launch. However a significant number of these banners violated regulations on pharmaceutical promotion in Sri Lanka, the regulations of the US FDA and the Code of Practice of the International Federation of Pharmaceutical Manufacturers Association of which BMS has been a long standing member.

All pharmaceutical advertising without exception should have the generic name of a drug. As an example, if the well-known sedative Valium (manufactured by Novartis) is being advertised, it must have the generic (=scientific) name of diazepam in the advertisement. The pharmaceutical companies are well aware of this as this was a hotly debated topic in the 80’s. It was finally accepted by all parties (pharmaceutical companies, regulatory authorities, patients and consumers) worldwide and incorporated into the regulations of the countries and codes of practice of pharmaceutical companies. The banners of BMS violated these codes and regulations.

I mentioned this to Mr Chris Robins the highest official from BMS at the launch, who admitted that it was a fault and that it would be corrected. It does seem rather late in the day for correction as this was discussed and argued in the 80’s and agreed in the very early 90’s and this is 10 years after.

What implications/consequences does this have for the United States government and for you as the representative of the government. It appears that the US government has been co-opted into a promotional activity that violates the regulations of the US FDA, the regulations of the Cosmetics Devices and Drugs Act of Sri Lanka and finally the code developed by the industry itself. If consumer organizations in the United States who keep a close watch on the activities of pharmaceutical companies (such as Public Citizen headed by Ralph Nader) were to become aware of this, it would reflect very badly on the US government and on the Embassy itself in Sri Lanka. Perhaps you could bring this to the notice of BMS official himself (Mr Chris Robins) or to their corporate head quarters as that should rectify matters. I have no objection to my letter being copied to BMS.

I was wondering as I wrote this letter what useful outcome this could achieve for the future. After all what is requested is that the company adhere to the regulations that are in the US as well as in Sri Lanka but then the US Embassy could not be expected to keep track of all these regulations. Perhaps after this, when the US government is officially invited to an event promoted by a US company, it might be worthwhile to check from the company whether they are following the regulations of the US as well as that of Sri Lanka.

One final word and it is not because I am Sri Lankan. I do think the local agents Walker & Greig are not to be blamed on this as they are new to the field and would not have known all the regulations; I have a sneaking feeling that these banners were sent by BMS (Pakistan), not a country noted for ethical pharmaceutical advertising. Perhaps another useful outcome might be if BMS headquarters (not from Pakistan!) could have a workshop for Walker & Greig pharmaceutical personnel on Pharmaceutical Promotion and the regulations and codes that govern it.

Yours sincerely

Prof. K Weerasuriya
Professor of Pharmacology &
Secretary, Drug Evaluation Sub-committee, Ministry of Health

Bristol-Myers Squibb Pakistan (Pvt) Ltd.
Plot 5, Se(-tor 21, Korari8i Industrial Area, Karachi-74900
Tel :          92-21-5015007       to 11(5 lines) Fax : 92-21-5013291

June 6, 2000

Prof K. Weerasuriya
Professor of Pharmacology & Secretary
Drug Evaluation Sub-committee
Ministry of Health
Colombo
Sri Lanka

Sub: Launching of Bristol-Myers Squibb Agency in Sri Lanka - 30,h April 2000 at the Hilton

Dear Prof Weerasuriya,

It was indeed very nice meeting you in Colombo at the Hilton on 30 th April 2000.

We have received a copy of the letter which you sent to US Ambassador Mr. Shaun Donnelly. We are thankful to you for pointing out our inadvertent mistake of missing of generic name of our brands on 2 banners. You would recall the rest of the 12 banners were compliant to IFPMA code of marketing practice. When you pointed out this omission to Mr. Chris Robbins, he had accepted this and we instantly took the action and asked our sales people to remove those 2 banners and destroy them. All advertising materials are approved by myself (being responsible for Medical & Regulatory affairs of Pakistan, Sri Lanka, Bangladesh & Maldives) before display / distribution and I will make sure that this happens in the future for all materials to be used in Sri Lanka.

We can not comment on your views on the status of ethical pharmaceutical advertising in Pakistan, however, we can assure you of our commitment to comply with the IFPMA code of Ethical Marketing Practice as well as the local laws of Sri Lanka, in the same way as we do in Pakistan and other countries where we do business.

We appreciate your valuable guidance and look forward to further input as we develop our business in Sri Lanka. Your suggestion to hold a workshop on Code of Ethics of Pharmaceutical promotion for the personnel of Walkers & Graig is an excellent one which we intend to implement in the near future.

With best regards,


Dr Raza Zaidi
Sr. Director Medical & Regulatory Affairs

cc. Mr. Shaun E. Donnelly
Mr. Christopher Robbins
Mr. Michael S. Owen
Mr. Anjum Fasih
Mr. Anis Shah


Dr. Raza Zaidi
Senior Director Medical and Regulatory Affairs
Bristol Myers Squibb Pakistan (Pvt) Ltd
Plot 5, Sector 21
Korangi Industrial Area, Karachi 74900
Pakistan

17 June 2000

Dear Dr. Zaidi,

Thank you for your letter of June 6th which was personally delivered to me.

I am glad that BMS has taken my comments in a very constructive manner. This would benefit both the company, and the doctors for whom promotion is intended, and ultimately the patients, who will receive the drug with good information.

However I did wonder about the comments in the second paragraph of your letter which referred to 2 banners being defective with 12 others being compliant with the IFPMA code. If a pharmaceutical factory manager were to have a failure of 2 batches in total of 14, this would call for a very serious review of all the Standard Operating Procedures and other aspects of manufacturing. Would the same ratio apply for failures in providing correct information during promotion or are such failures measured by a different yard stick?

There was also the statement “All advertising materials are approved by myself (being responsible for Medical and Regulatory affairs of Pakistan, Sri Lanka, Bangladesh and Maldives) before display/distribution and I will make sure that this happens in the future for all materials to be used in Sri Lanka”. I hope this will not only be for Sri Lanka but for Bangladesh and Maldives too as the IFPMA code require the display of the generic name wherever the product is advertised and I would certainly think that prescribers in those countries too would benefit from knowing the generic name.

As for my comments on the abysmal state of pharmaceutical promotion in Pakistan, it is on public record. For example, I do remember an article (which was published in the International Edition of the BMJ and NOT limited to the Pakistani edition) on the provision of information after a drug was advertised. Most of the requests for information by the prescribers did not even receive the courtesy of a reply.

The local representatives of BMS do appear to have started off professionally; they have employed a Regulatory Affairs Officer at the very beginning itself, which indicates their seriousness. Unfortunately some of the Multi National Companies in Sri Lanka did not have a regulatory affairs officer (that being done by the marketing manager) for some years.

In conclusion I am gland that BMS did take my comments in constructive manner and also appear to have imparted professionalism to their local agents in Sri Lanka. May this trend be continued in the future.

Thank you

Yours sincerely

Prof. K Weerasuriya
PS I have copied this to the US Ambassador in Sri Lanka and to the Pharmaceutical Division in Walker and Greig. I trust you would copy it to the others that are mentioned in your letter.

 

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963