The recent Pan Pharmaceuticals incident,where many herbal products were recalled,has far reaching consequences forthe industry,writes HOOI YOU CHING.
THE crackdown on Australia’s largest contract manufacturer of herbal and nutritional supplements, Pan Pharmaceuticals, in April this year has certainly affected the country’s complementary medicines industry.
Unfortunately, the extent of damage to an industry worth a whopping RM2.5bil (A$1bil) with exports amounting to RM500mil (A$200mil) went beyond just one company but involved retailers, other manufacturers and their employees, says Blackmores chairman Marcus Blackmore.
“Small retailers struggled against financial ruin and customers lost confidence. Large manufacturers (who weren’t affected by the recall) placed advertisements to counter the damaging publicity as consumers were getting confused over products manufactured by Pan under different brands,” he adds.
The action by the Therapeutic Goods Administration (TGA), Australia’s medicines watchdog, came after the travel sickness pill Travacalm made by Pan Pharmaceuticals caused several individuals to suffer serious side effects and hallucinations, including trying to jump off planes and boats.
Thereafter, Pan Pharmaceuticals had its licence suspended temporarily for six months after audits revealed a series of quality and safety breaches.
A consumer survey by Blackmores showed that awareness and concern about health supplements was high in the first week of the recall (99% respondents were aware of the product recalls), but consumer confidence was restored to some extent following marketing campaigns and media highlights. For example, 82% were “concerned about using health supplements at the moment” during the recall but dropped to 66% three weeks after the recall. Interestingly, the survey also revealed that eight out of 10 would continue to buy vitamins even after the Pan incident.
However, the survey also found that before the crisis, 65% of the consumers were making their own decisions concerning their health. After the crisis, it dropped to 45%, suggesting that individuals preferred to consult pharmacists and health professionals to reinforce their prescribing behaviour.
The Blackmores brand was first introduced in Malaysia in 1988 and is a major Australian company producing health and nutritional supplements.
Naturally, several herbal manufacturers were unhappy over the blanket recall of Pan’s products and began to question the action taken by TGA. This was because TGA issued a Class 1 recall, which classifies a product as being “a serious risk to health” or “potentially life-threatening”.
“No doubt in the aftermath of the Pan debacle, questions will be raised about the nature and timing of the recalls,” he continues.
Blackmore, who was recently in Malaysia to present a paper entitled ‘The Role Of Government And Natural Health Products – The Pan Pharmaceuticals Crisis and Implications for Industry and Consumers’, reiterates that existing regulatory systems are adequate since Australia already has the strictest regulatory regime in the world, where complementary medicines are regulated as drugs, unlike most countries where they are regulated as foods.
“Regulations require all complementary medicines to be registered under the ARTG (Australian Register of Therapeutic Goods). Complementary medicines are intrinsically safer than pharmaceutical drugs, and as such they are generally placed on the ‘listed’ category of the ARTG because they are considered ‘low risk’ by the government, whereas pharmaceutical drugs are placed on the higher risk ‘registered’ category.”
According to Blackmore – whose father Maurice Blackmore founded the company in the 1930s – it is incredible that what started as serious adverse reactions to a pharmaceutical drug (Travacalm HO) turned into a tirade of condemnation of complementary and alternative medicine.
“Our detractors, both academic and political, came out of the woodwork. The attack on the industry only serves to highlight the need for the authorities to have an accurate and reliable source of information totally independent from the regulator (TGA) with its inherent disposition to a pharmaceutical drug model of thinking,” he emphasises.
Nonetheless, he agrees that any manufacturer who does not abide by the Code of Good Manufacturing Practice (GMP) deserves to be penalised.
“But to use the Pan debacle to infer complementary medicines are not safe or efficacious is a gross and irresponsible distortion of the facts. The Pan complementary medicines were recalled because of the TGA’s genuine concern about manufacturing practices, not adverse reactions reported by the general public. To the best of my knowledge, Pan manufactured something like 11 billion tablets and capsules in the past year and there hadn’t been reported adverse reactions from the general consumer,” he argues a point.
Describing April 28 “as the blackest day our industry has ever had,” Blackmore feels that the Australian government is not looking objectively enough at the alternatives, in this case the herbal and complementary medicine, which has the potential of significantly reducing public healthcare costs in the country.
“Under the existing system, an escalating RM10bil (A$4bil) of taxpayers’ money is used to subsidise prescription drugs whereas complementary medicines are paid through consumers’ after tax dollars and a whopping RM325mil (A$130mil) goes to government coffers in the way of the discriminatory Goods and Services Tax (GST).
“In 1997, a US study by Bendich noted that nearly RM50mil (A$20bil) in hospital charges were potentially avoidable with daily use of folic acid and zinc containing multivitamins by all women of child-bearing age and daily Vitamin E supplementation for those over 50.
“We’ve had a significant dependency on drugs and now we realise it’s not all it’s made out to be. There’s a growing body of evidence that health supplements can reduce the incidence of chronic disease. In fact, researchers from Harvard Medical School, after having reviewed 152 published studies over 40 years, recommended in July 2002 that it would be prudent to take a multivitamin pill daily,” he continues.
In light of the Pan issue, Blackmore feels that it would be meaningful for the Australian government to increase research funding in complementary medicines and alternative health practices.
“In 2001, we spent a meagre RM162,500 (A$65,000) in research on complementary medicines versus RM500mil (A$200mil) in the pharmaceutical area. When 60% of Australian adults use complementary medicines regularly and some 80% of Australian GP’s refer patients for complementary treatments, it may be opportune, if not a responsibility, for the government to address this anomaly.
“Adequate research would dispel anxieties and mistaken beliefs about the efficacy of complementary medicines and boost public confidence in a vital industry that receives virtually no government support,” he says, adding that at least 10% - 20% should be directed towards R&D in complementary medicine.
In the Australian context, the quality of manufacturing standard is ensured through GMP, safety issues are governed by a national register like the ARTG, whereas efficacy claims are controlled by an evidence-based model provided by the Complementary Medicines Evaluation Committee (CMEC).
“The government should establish a Complementary Medicines Advisory Group to independently advise on policy and regulatory issues in relation to natural health products. The problem lies not with the law itself, but with the application of the law.
“Remember, the sign might say 50km/h but some will still break the law,” he quips.
And the next question: Would subjecting complementary medicines to pharmaceutical standards of practice solve manufacturing discrepancies in the former?
“The claim that drugs and complementary medicines should be subjected to the same regulatory procedures is misguided, at best. On the one hand, vitamins and herbs have been consumed for decades, if not hundreds of years, whereas most pharmaceutical drug products are produced from previously unknown chemical entities that have not existed on the planet before.
“The evolution of a pharmaceutical industry resulted from a desire to standardise the dosage forms for patients. One of the problems with herbal medicine is that herbs vary in terms of composition and quality depending on climate, soil and time of harvest. Nature doesn’t create an entity where you can chemically extract one active ingredient,” he explains.