Health Supreme by Sepp Hasslberger

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February 12, 2004

Australia - Senator Questions Natural Products Recall

The Australian Health Authorities, in June last year, recalled more than a thousand different food supplements manufactured by Pan Pharmaceuticals and had them destroyed in a thinly veiled attempt to destroy the credibility of nutritional products for health care. The mega-sequester came at a time when Australia apparently wanted to show "leadership" in how to deal with natural products, firmly establishing the Therapeutic Goods Administration as the lead agency in a proposed Trans-Tasman scheme for a joint ANZO health authority.

The recall of products was highly irregular. It hit the supplements produced by Pan Pharmaceuticals but left that company's pharmaceutical production untouched. It was sparked off by adverse event reports on Travacalm, a pharmaceutical product, not a supplement. Yet, more than a thousand supplements were recalled and destroyed. Why? No one knows, but a Senator is now trying to find out. Senator Lyn Allison is asking the minister of health. The answers should be interesting....

Thanks to Jennie Gorman for forwarding this information.

From: Ramm, Natasha (Sen L. Allison)
Sent: Monday, 9 February 2004 8:15 AM
Subject: Senator Allison - Questions - Different Treatment for Complementary Health

Senator Allison put the following questions to the Federal Government on the TGA's Pan Pharmaceuticals recall and on its failure to act on the very large number of adverse reactions and deaths each year attributed to pharmaceuticals.

Office of Senator Lyn Allison
QUESTION ON NOTICE - asked 2nd February 2004
Senator Allison asks the Minister for Health and Ageing;

1. Why were the 1369 Pan Pharmaceutical products destroyed following their recall in April 2003?

2. a) Were any of these products tested?
        b) If not, why not?

3. a) Were any of those products the subject of reported adverse reactions or death?
        b) If so, can details be provided?

4. What were the total quantities returned for each of those products?

5. How many of these products were destroyed and where?

QUESTION ON NOTICE - asked 2nd February 2004
Senator Allison asks the Minister for Health and Ageing;

1. How many PBS prescriptions have been filled each year since bupropion, or zyban was approved by the TGA in 2000?

2. What are the conditions for which bupropion is listed and approved?

3. Can a copy of the TGA’s pre-market evaluation of zyban or bupropion be provided?

4. How many adverse reactions to bupropion have been reported to ADRAC each year in Australian since 2000?

5. How many deaths have been attributed to the consumption of bupropion each year in Australia since 2000?

6. How do the statistics for 4) and 5) above compare which those of the UK, USA and Canada?

7. How many deaths and/or adverse reactions would normally warrant a Class 1 product recall?

8. Did the TGA consider recalling this product, and if so what were its conclusions?

9. To what are the adverse reactions and deaths attributed?

10. What testing has the TGA conducted on bupropion?

11. Can details be provided of the 20 pharmaceuticals in use in Australia which generate the most complaints to ADRAC of deaths and adverse reactions, by year since 1990 together with an indication of the action taken by the TGA to each?


Years later - April 2007:
Democrats Demand Howard Apologise for Pan Pharmaceuticals Witch Hunt

The Howard Government must now apologise following the acquittal of Pan Pharmaceuticals boss Jim Selim in the New South Wales Supreme Court. The pharmaceuticals giant was forced into administration in May 2003 following the largest pharmaceutical recall in Australias history.

It was a pointless exercise targeting complementary medicines and it sent hundreds of small businesses broke, Democrats leader and Health spokesperson Senator Allison said today. The Howard Government turned its back on the mess and just walked away.

1500 products were recalled, not because they caused adverse reactions, but because of speculation about inconsistent quality. Senator Allison raised concerns in the Senate at that time about what was playing out as a destructive over-reaction.

Mr.Selim was accused of a litany of charges, including breaching his manufacturing licence. In the end only two counts made it to court which were thrown out today.

The unprecedented recall had a devastating effect on small businesses and shook public confidence in complementary health, Senator Allison said. The very least those who have suffered deserve is an apology.


posted by Sepp Hasslberger on Thursday February 12 2004
updated on Friday April 20 2007

URL of this article:


Related Articles

Natural Products Recall in Australia - Push for tougher regulations?
The Australian TGA - Therapeutic Goods Agency - has recently ordered an unprecedented recall of more than a thousand three hundred natural products formulated and produced for other companies by Pan Pharmaceuticals. Public warnings by the agency stated consumers should not use any natural products, while emphasising that there was "nothing wrong" with the pharmaceutical medicines produced by the same company?! Australia and New Zealand have been talking for some... [read more]
June 20, 2003 - Sepp Hasslberger

Australia, New Zealand - Codex Alimentarius and Trans-Tasman Harmonization
Efforts to harmonize rules on supplements between Australia and New Zealand, by establishing a Trans-Tasman joint agency for the control of natural health products have been going on for some time. I previously reported on this here, here and here. (The Tasman Sea is a large body of water that separates New Zealand from the Australian continent.) The situation "down under" really got hot when the Australian health products and... [read more]
May 09, 2005 - Sepp Hasslberger

New Zealand: Supplements to be 'Medicines'
For Europeans and Americans, New Zealand and Australia seem so far away we don't usually think that what happens "down under" is going to affect us in any way. Better think twice. What is happening there does have relevance to us. In fact we are facing attempts by the European Union and by the FDA to "regulate" supplements that are not dissimilar to what is happening on the other side... [read more]
May 10, 2004 - Sepp Hasslberger

Australian Supplement Laws for New Zealand?
It is called Trans-Tasman harmonization, and it's an effort to make the laws the same on both sides of the Tasman Sea, the body of water separating Australia from New Zealand. In this case, we are talking about the laws regulating the production and sale of food supplements, products containing nutrients in concentrated form and in health-effective quantities. Supplements are regulated as medicines - therapeutic goods - in Australia, while... [read more]
December 05, 2003 - Sepp Hasslberger

Australia to clamp down on natural medicines
Further to: Health Choices Going Going Gone . Following is typical of the spin doctoring that the industry and it's ancillaries (ie government bodies and others) use to convince us of the miss use the of already slim regulatory resources to protect the business with disease. A perfect example of a government regulatory body, the Australian Therapeutic Goods Administration (TGA), funded by vested interests masquerading to protect the pubic from... [read more]
November 05, 2003 - Chris Gupta

Risk Free Vitamins - How Safe is Safe Enough?
Recent legislative proposals on at least three continents have centered around the perceived need to ensure the safety of natural health products, such as supplements containing vitamins and minerals. Canada has proposed drug-style regulations for supplements. In the US, a proposal termed S 722 seeks to increase the FDA's powers to remove supplements from circulation. Australia recalled 1600 diverse health products in an unprecedented prelude to - what else -... [read more]
February 03, 2004 - Sepp Hasslberger




Readers' Comments

Good for Sen Allison. I would like to see the answers to her questions, so would millions of others. Any chance of that happening ?

Gary P

Posted by: Gary Powell on August 9, 2004 11:16 AM


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