Published by Computachem Services

P.O Box 297.
Alstonville. 2477
NSW Australia

Phone:
61 2 66285138

Editor's Note: With various political luminaries, such as Trish Worth and Bob Carr, making derogatory statements in the national media regarding complementary medicine, and using the PAN debacle as somehow illustrating and supporting their position, it is time to introduce an element of balance back in to the debate.
Readers are reminded that the PAN issue was one of good manufacturing practice (not the efficacy of complementary medicines), and that there were two pharmacists on the board of that company.
Product recalls are a fact of life, are quite frequent, and most relate to pharmaceuticals made by reputable companies.
It is the size and manner of the PAN recall that attracts attention, and the disruption and confusion in the wake of the recall does not reflect well on the TGA, or those choosing to make malicious comment regarding complementary medicines.
Also, the number of businesses that were hurt permanently (including PAN), demonstrates a certain form of callousness in the process.
We publish a letter provided to us by Trevor Bamford, as he presents his side of the case to his local member.
Trevor owns a health food store, that he runs with a high degree of professionalism.

FROM: Trevor Bamford BSc, 20 Figtree Street, Coomera QLD 4209

TO: The Honourable, Mr David Jull MP, P.O. Box 134, Springwood QLD 4127

CC: Prime Minister The Hon John Howard MP; Minister for Small Business - The Hon Joseph Hockey MP; Minister for Health & Ageing - Senator The Hon Kay Patterson MP; Parliamentary Secretary to the Minister for Health & Ageing - The Hon Trish Worth MP; Member for Fadden - The Hon David Jull MP; Member for Bowman - The Hon Con Sciacca MP; Executive Director - Complementary Healthcare Council of Australia - Ms Val Johanson

Thursday 19th June 2003

Dear Mr Jull,

14 Million Australians Can't Be Wrong

I am writing to you to express my concern about :

1. The manner in which the recent national medicines recall has been handled by the Therapeutic Good Administration (TGA).

2. The current Government's attitude toward complementary healthcare in light of the fact that fourteen (14) million Australians regularly take and gain benefits from complementary medicines.

3. The recently appointed "Expert Committee" that will review the "relevance" of the complementary
healthcare medicines industry to the Australian national health system and report back to the
Government mid August 2003.

My family own and operate Natural Alternative - Bayside, a small health food retail business situated within Capalaba Park Shopping Centre at Capalaba in Bayside, Brisbane.
We have, until the PAN recall crisis, employed up to seven (7) local residents - some of which live within your electorate in the southern end of Redland Shire.
We have been operating in the same area for twenty (20) years and have developed a great rapport with our customers, servicing some 800-1000 customers per week, and providing high quality natural health solutions and support information based around their specific natural healthcare needs.

As you are no doubt aware, our industry and in particular health food retail shops like ours are currently experiencing a great deal of uncertainty and financial difficulty as a result of the PAN Pharmaceuticals Ltd recall.
We have, as a direct result of this recall, had to lay off staff, approach our landlord for financial relief as well as negotiate with our supply network for extended terms of credit to enable us just to survive through these very rough times.
The impact that this recall has had on our long-standing business has been devastating.

THE MANNER IN WHICH THE RECALL HAS BEEN HANDLED BY THE TGA

I believe with the utmost integrity that consumer safety is of absolute importance none moreso than in the area of the manufacture of internal medicines and consumer health.
I have always gained a great deal of comfort from running a business which we choose to associate with our industry body which demands strict adherence to a marketing / advertising code of practice for membership. (see the Complementary Healthcare Council of Australia : http://www.chc.org.au).
More importantly however, is the fact that I daily communicate to consumers about complementary medicines, with the full confidence and knowledge that in Australia, the level of regulation of such products by the TGA, has been and continues to be at a very high standard since 1989.

For example :

* complementary medicine products in Australia are made to pharmaceutical GMP standards audited by the TGA, whereas in the UK, NZ and the USA they are made to a food standard.

* All advertising for complementary medicines must be approved for mass media and receive an approval number by an ACCC and TGA audited advertising standards body BEFORE going to press.

* Complementary medicine products must be registered with, and audited, for approval by the TGA BEFORE they go to market, and can only contain ingredients that have been approved

The PAN recall, the speed at which it was instigated and the method in which the recall process itself was executed leaves these following questions - ones that have been asked by both my customers and by myself - unanswered.

1. Why, if the TGA had audited PAN and had evidence dating back twelve months of GMP breaches, did the TGA, (knowing as they would of the ramifications of suspending such a manufacturers license insofar as the extent of product that would be needing to be recalled), not work with both PAN and industry to :

a) Issue a firm deadline to PAN to demonstrate absolute compliance to GMP requirements OR ELSE face immediate suspension, and

b) Identify a comprehensive list of goods that were to be recalled PRIOR TO issuing a public statement suspending PAN ?
The wave-like manner over a period of weeks in which the recall lists were published caused much alarm and personal grievance within our consumer marketplace (in particular within the elderly), as to what to do and how to act.
Surely the issue of public safety extends to ensuring that the public are not left in a heightened state of alarm?
Surely the TGA would have, upon assessing the level of danger posed to the consumer marketplace by PAN made medicines, determined as to what would be the most effective and efficient means of communication?
Say it once and say it well would be intelligent.

2. Why did the TGA not make public a statement about the fact that complementary medicines are regulated by the TGA concurrently with other medicines albeit to a lesser level but at a level that is based on risk versus benefit assessment?
The fact that the TGA did not act to allay public fear in the face of unlawful media coverage makes the TGA, in my opinion, party to the dissemination of wrong information that served only to confuse the Australian public into believing falsely that complementary medicines are not regulated by any body.

Any effort you could make to find out the answers to these questions on my and my customers behalf would be sincerely appreciated.

The fact that the complementary healthcare industry, one that is regulated and that contributes greatly to Australian health and to export income for Australia, has been allowed to be damaged by the current Government, is extraordinary.

The fact that many consumers - in particular the elderly - have been left confused and unsure about the security and safety of their choice to act preventatively with their health by accessing complementary medicines is extraordinary.

The fact that consumers should have been communicated to directly by the Government and told that the recall was a result of one company's QA breach, and NOT the result of an unregulated industry, but weren't, is also extraordinary.

The fact that the Government has not acted prudently to facilitate a more harmonious outcome to this issue both for the industry and for the consumer is made more inexplicable through the establishment of what appears to be a very partial "expert committee" whose job it is to determine the fate of my business and our industry.
In respect of this I have several concerns about this committee including the fact that :

* The committee has no expertise from the important health food retail sector, or herbal manufacturing.

* There is no Naturopath and no General Practitioner who practices complementary healthcare.

* The committee has representatives from pharmaceutical companies, and the Over-The-Counter (OTC) pharmaceutical industry body but our industry association, the Complementary Healthcare Council, is not represented. (Editor's note: the CHC is now represented through its consultant)

* Some members on the committee have previously voiced opinions that are ill informed, and very derogatory and biased, against complementary medicines.

In light of the fact that our industry is subject to TGA regulations and that this PAN recall has been instigated as a result of this one company's QA breaches, can you please explain to me why this committee is needed, and why members of the public or affected stakeholders like me, or my significant suppliers or industry association, do not have a voice ?

I would be very keen if you could forward to me a copy of this report once it is made available in mid-August 2003.

In closing, please be aware that I am deeply concerned at the Government's attitude that refers to our industry as "backyard operators" and calls on the public to "lose faith in the complementary healthcare industry".
Consumers are confused and our industry is suffering as a result of the PAN recall and we need Government support to rebuild it.
I would like to emphasize to you how concerned my customers are that the Government seems to be failing to assist or support the complementary healthcare industry when they so clearly support and want access to this industry Australia-wide.

I urge you to do all you can to ensure our industry has certainty and has support from Government.

I look forward to your support in the future. I look forward to your response.

Yours Sincerely,

Trevor Bamford BSc
Mob : 0403 575 055
Home : (07) 55 730 371
Email : trevorbamford@optusnet.com.au
Work : (07) 3390 2161