The recent out of court settlement with Pan Pharmaceuticals founder Jim Selim could have been avoided had the complementary medicine sector been subject to an appropriate regulatory regime.
Although the initial enquiry focused on a conventional pharmaceutical product — Travacalm — the investigation quickly expanded to cover the broad range of complementary medicines produced by the company.
Had complementary medicines been subject to the same or similar regulatory frameworks as conventional health products standardised and objective policies procedures would have been put in place during this process.
This may have prevented the overzealous response the president of the Complementary Healthcare Council, Dr Wendy Morrow, called “one of the worst periods for the complementary medicines industry.”
However the opposition of groups such as the Complementary Healthcare Council to development of appropriate regulatory mechanisms may have actually played a hand in the demise of Pan.
Misinformed reactions to adverse events are one of the risks of an unregulated sector. This risk stems directly from the extreme variability of product standards and manufacturing practices in the sector — and the general confusion generated in an industry essentially allowed to play by its own rules. This confusion generates reactionary rather than rational responses when things do occasionally go awry.
Pan is not an isolated case as this confusion has also extended to a number of other complementary medicines. An Omaha woman was allowed to sue a herbal medicine manufacturer for liver failure after consuming a supplement containing Black Cohosh, despite later investigation uncovering that she was concomitantly taking several pharmaceutical medications highly associated liver failure in addition to being a heavy drinker.
Kava was immediately implicated in the death of a Melbourne woman by liver failure despite the herbal supplement she consumed containing several unidentified components. The complementary medicine industry cries foul when incidents such as these happen, but refuses to allow objective evaluation of their products when it doesn’t suit them. If the industry is to fulfil the larger role it desires in Australian healthcare it needs to be far more objective on these issues.
Complementary medicines do exhibit enough risk to warrant regulation, though when used judiciously they generally pose no more risk — and often substantially less — than conventional medicines.
It is time to stop treating complementary medicine as a special case and start treating them for what they are — health products like any other. If complementary medicines are appropriately regulated the industry may need to endure more responsibility and accountability — though no more than any other health industry — but will also accrue benefits such as objective rather than reactionary evaluation of safety concerns.
Hopefully the Selim payout is a $55 million mistake the government will learn from and begin an appropriate regulatory regime for these medicines.