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
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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?
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Years later - April 2007:
Democrats Demand Howard Apologise for Pan Pharmaceuticals Witch HuntThe 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 2007URL of this article:
http://www.newmediaexplorer.org/sepp/2004/02/12/australia_senator_questions_natural_products_recall.htm
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