Hyoscine

What began as either an act of carelessness or a deliberate attempt to flout regulations by a manufacturer has resulted in a furor that calls into question the future of the entire "complementary medicine" industry in Australia.

Australia has a two-tiered regulation system for health-related devices, medicines, and food supplements, administered by the Therapeutic Goods Administration (TGA--the Australian counterpart of the Food and Drug Administration). It requires all prescription, plus some non-prescription pharmacy medicines (paracetamol, aspirin, etc.) to be "registered" together with evidence of their safety, quality control in manufacture, and efficacy. Other items, those that are considered to present lower levels of risk, are "listed," requiring only evidence of safety and quality control. The overwhelming proportion of complementary medicines, vitamins, minerals, and food supplements sold in Australia are listed items. All products are required to display on their packaging either an AustR(egistered) or AustL(isted) number, indicating the level at which they are regulated.

In January 2003, TGA was notified of serious illnesses suffered by some eighty people (nineteen requiring hospitalization) who had taken a popular travel sickness preventative medicine, Travacalm, a Registered product. Concerned by this, TGA conducted an analysis of Travacalm purchased from a pharmacy, revealing that tablets in one package contained amounts of the active ingredient, hyoscine, varying between none at all and seven times the safe dosage.

These alarming results caused TGA to conduct an immediate audit of the manufacturer, Pan Pharmaceuticals Ltd., to test its compliance with regulations. Pan, a listed public company, makes and markets a wide variety of complementary healthcare products under its own brand names, as well as being a contract manufacturer for several other companies. The audit found serious quality control failures in the process, along with other faulty manufacturing practices that rang alarm bells. TGA then expanded its audit to all products manufactured by the company, including not only its relatively small range of Registered products, but also its far larger range of Listed items. At that stage, Pan was the manufacturer of a high proportion of listed supplements and medicines sold in Australia, as well as others for export to forty countries.

Charging Pan with unacceptable manufacturing procedures, inadequate quality control, falsification of records, and other misdemeanors, TGA revoked its license to manufacture in April 2003. It then instituted an immediate compulsory product recall of (at last count and ongoing) more than 1,500 products, by far the largest recall of health-related (or any other) products in the nation's history. Several companies marketing products made by Pan, but sold under their own brand names, were caught in the net, with fourteen who failed to comply with TGA reporting procedures also having their licenses revoked.

Consternation, verging on panic, reigned throughout the entire alternative health industry. Health food shops and pharmacies denuded their shelves of suspect vitamin, herbal, and mineral supplements; spokespeople for the alternative/ complementary healthcare industry took to the newspapers and the airwaves in serried ranks, aiming blame at the regulators, the government, the medical "establishment," multinational pharmaceutical companies, and anyone else who they thought appropriate; lawsuits were launched in all directions; bewildered consumers stopped taking their (often self-prescribed) pills and besieged their suppliers demanding refunds. To date, no cases have been reported of anyone suffering any ill effects from ceasing to take their pills.

Aided by an unfortunate relaxation of the advertising regulations for healthcare products, sales of complementary medicines have undergone massive increases in the past five years, with a 2001 study conducted by Adelaide University suggesting that they amounted to $2.4 billion (Australian) per year. Once the staple of health food stores, they have since become major sellers in pharmacies, some of which display a whole wall of assorted varieties of snake-oil remedies. With that much money at stake, it is hardly surprising that the level of complaint from the industry was high.

The spin they sought to put on the facts was higher still. Representatives of the industry lobby group the Complementary Healthcare Council (made up of manufacturers, resellers, and "alternative" practitioners) approached the Federal Government, seeking a grant of $11 million of taxpayers' money to fund "public education on the benefits of complementary health supplements." Amazed at the sheer effrontery of this claim, Australian Skeptics immediately countered with a petition to its local Member of Parliament, requesting that no such funds be allocated, suggesting rather that any available money would be better spent on educating the public that most supplements were unnecessary and many other complementary medicines were untested for efficacy. (As our local MP is both a medical practitioner and the Federal Minister for Education, we felt we were on firm ground.)

Then things went from bad to worse for the industry. While the media interest was at its height, the Premier of New South Wales, Hon. Bob Carr MP, appeared on TV saying, "... it appears that most of these products give no more benefit than colored water"; a national TV science program, Catalyst, aired a report on their investigation into various herbal remedies, which showed wide variations in the amount of active ingredient and lack of uniformity in many preparations; the chairman of the Australian Olympic Committee, John Coates (alert to the threat posed to athletes by inadvertent ingestion of proscribed substances), called for much sterner regulation of the labeling of supplements.

More important, it now seems that Australian Skeptics' long years of advocacy that providers of "alternative" medicine be held to no lower standards of accountability than apply to orthodox medicine might at last bear fruit. The government has introduced legislation requiring a much higher degree of compliance, evidence of efficacy, and accuracy in labeling for manufacturers of complementary medicines, with very large financial penalties for noncompliance. Further, it has announced an inquiry into the entire alternative medicine industry, to report to Parliament within three months. Sanity might just stand a chance.

One final lighter note. During the media frenzy a group of enterprising orchardists placed advertisements in metropolitan newspapers. Showing simply a picture of a shiny red apple, it bore the cogent caption, "The Alternative to Alternative Medicine." We couldn't have put it better ourselves.

Barry Williams is Executive Officer of Australian Skeptics Inc., Roseville, NSW, Australia. E-mail: skeptics@kasm.com.au; Web site: www.skeptics.com.au.

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