Healthy Skepticism Library item: 9351

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Harvey K.
Schwabe Pharma Australia & Natural Health Products - litigation update
AusPharmList (subscription required) 2007 Apr 5
http://www.auspharmlist.net.au/post.php?postid=9858

Full text:

Listers will recall that last year Schwabe Pharma Australia Pty. Ltd. and Natural Health Products Pty. Ltd. (Schwabe et. al.) took the newly formed AusPharm Consumer Health Watch group to court in order to prevent a report about the efficacy and promotion of one of their products: Tebonin® a proprietary extract (EGb761®) of Ginkgo biloba.

The injunction sought by Schwabe et. al. was granted in the Federal Court by Justice Greenwood who argued that the public interest was best served by allowing regulatory authorities to adjudicate on the concerns raised by the AusPharm group. Complaints about the promotion of Tebonin® were ultimately upheld (and the issues addressed by Schwabe et. al.) but meanwhile the AusPharm Consumer Health Watch had disbanded because of the cost of the litigation (both financial and emotional).
The case was widely publicised in the medical and lay press, both in Australia and Germany.

Subsequently, I met with the principals of Schwabe et. al in order to clear the air over these matters. We agreed that all parties lost through the action that eventuated. Both bore the cost of litigation. AusPharm Consumer Health Watch disbanded. Schwabe et al. had their reputation damaged and lost sales as a result.

We also agreed that there are ongoing problems with the current regulation of complimentary medicines compared with prescription and OTC products.

There are double-standards with respect to advertising as exemplified by the recent decision of the National Drugs and Poisons Scheduling Committee (NDPSC) to ban advertising of orlistat (Xenical) while the promotion of numerous herbal weight loss products (of much more dubious
efficacy) continues unabated.

There are problems with allowing sponsors to merely “certify” they hold evidence for the claims made about complimentary medicines with only occasional checks being made by the TGA. We agreed that many of the claims made for complimentary medicines listed on the Australian Register of Therapeutic Goods do not appear to be supported by appropriate evidence. We were both supportive of a regulatory process that demanded a higher standard of evidence to support the promotional claims made.

We also noted that a particular herb contains many different chemical constituents, the presence and concentration of which varies depending upon the source of the herb and the extraction and standardisation methods used. Marked variation of chemical constituents have been found in different commercial products that purported to contain the same amount of a particular herb. Currently, the TGA accepts crude assays of analysis that do not necessarily confirm that a particular herbal product has the same chemical constituents of another that has been proven to be clinically effective. In addition, the TGA does not require stability data on Listed products. We were both supportive of more stringent standards by the TGA with respect to the chemical composition of herbal products.

Schwabe et al. also mentioned that they are attempting to gather industry support for higher regulatory standards for complimentary medicines, an endeavour I also support.

In conclusion, discussions with Schwabe et al. have reiterated that “jaw, jaw” is always better than “war war”. Our experience shows that even once bitter opponents can often find areas on which they can work together if only they stop communicating via lawyers and sit down face-to-face.