NOT only is the recall of therapeutic supplementary medicines and herbal products the biggest in Australia’s history, but it is also the tip of an iceberg.
It is causing chaos across the nation and, perhaps, serious concerns overseas where many of the drugs have been exported as consumers hastily check whether their tablets are among those banned by the Therapeutic Goods Administration (TGA).
Already 1,369 products are on the immediate-recall list as a result of alleged substitution of ingredients by a rogue analyst, who has been sacked by Pan Pharmaceuticals in Sydney.
The products include common tablets for cold and flu, slimming pills, children’s chewable vitamins, weight-loss pills, libido enhancers, antioxidants, evening primrose oil and cod liver oil.
Originally, 219 products manufactured by Pan were blacklisted. But the number kept rising as more companies informed TGA that their products in their own brand names had been contracted to Pan for manufacturing.
Pan, the biggest contract manufacturer of complementary medicines in the country, has 40% of the Australian market. It also produces drugs for Bio-Organics, Golden Glow, Nature’s Own, Natural Health and Bullivants.
These products are exported to about 40 countries. Among its over-the-counter medicines are paracetamol, codeine, anti-histamines, pseudo-ephedrine and the cholesterol control drug Cholest-off.
Unfortunately, in most cases, it is difficult to identify who manufactured the products of different brand names, as there is no law in Australia to compel manufacturers to carry their names on the label. There is only the international code with the batch numbers.
This lack of statutory requirements will be remedied in an amendment to the manufacturing of drug laws to be introduced in the next session of Federal Parliament.
Pan’s manufacturing licence was suspended for six months last Monday after the TGA investigations revealed several breaches of regulations. They include the substitution of ingredients, deliberate manipulation of test results and substandard manufacturing processes.
The suspension shook the A$1.2bil industry, threatened 5,000 jobs and the possible closure of up to 500 small businesses throughout Australia.
It also raises the possibility of A$20mil refund to consumers as millions of tablets are being dumped. Legal actions against the company by those who have been severely affected and by Pan’s three biggest customers – Mayne Group, Sigma and Australian Pharmaceutical Industries – are also being considered.
The harshest critics of the drug scandal are New South Wales Premier Bob Carr, who compares natural therapeutics to “medicine-man hucksters,” and Australian Consumers Association health policy officer Martyn Goddard.
“We have more quackery and more snake-oil salesmen now than we did in the 19th century, and consumers are being conned into paying through the nose for this stuff,” Goddard says. “People should be asking themselves whether they need complementary medicines at all.”
The row led Prime Minister John Howard to urge the public not to panic and to assure them that prescription medicines are not affected by the scandal.
In the midst of the crisis, however, two previous incidents resurfaced to add to the negative reactions of the discredited Pan.
One reminded the public of its chief executive officer John Selim being suspended for three months by the State Pharmacy Board 27 years ago when he sold some paracetamol tablets that were found to be placebos.
The other incident involved Pan being fined A$280,000 in 1995 for selling and exporting evening primrose oil that had not yet been approved as a therapeutic product at the time. The company successfully appealed against the decision and a trial is still pending in a Sydney High Court.
Selim, who was named last year as one of Australia’s 200 richest people with a personal fortune of A$200mil, resigned from his management position on Thursday after Parliamentary Health Secretary Trish Worth said she would be surprised if Pan got back its manufacturing licence while he was still in charge of the company.
The latest scandal emerges after 19 people had been admitted to hospitals and 68 others had severe reactions as a result of taking some travel sickness tablets called Travacalm since January.
One of the two worst affected victims is a 10-year-old bubbly student who became desperately ill during a school holiday camp.
Her teacher, Jenny Maffley, says the girl was disorientated. She had “no balance and was seeing things and asking crazy questions.” An ambulance was called to take her to hospital.
The other victim, Sydney stockbroker Mark Tooher, complained of “non-stop nightmarish, ghoulish images of spiders and other things” while awake.
“I was almost clawing my head to get them out,” he adds. “I did not have any control over what was bombarding my mind. I was acting like a crazy man.”
Tooher, 37, claims that the drug ruined his overseas holiday and cost him about A$30,000 to try and find a cure. He still hallucinates months after he stopped taking Travacalm.
TGA principal medical adviser Dr John McEwen accuses Pan of endangering lives because some of the products were found to contain active ingredients at many times the normal level. Pan has also been accused of obstructing an audit in January and that an employee of the company deleted records from a computer.
In fairness to the company, the classic ingredient called hyocine hydroromide – a relative of atropine – in Travacalm that apparently causes adverse reactions has been used for many years without problems.
Surprisingly, TGA investigations seem to suggest that it is “some sort of hyocine poisoning.” What seems to be curious, though, is that a person taking a tablet from the same packet one day had no problem at all but taking it on another day had hallucinations or marked physical disturbances.
“This does not fit the normal picture,” Dr McEwen admits.
He believes the only explanation could be the amount of active ingredients varied very much between one tablet and another in the same packet.
Judging from his comments, it is likely that Pan would have got away with a stern warning or a fine, without its licence being suspended, had it admitted at the outset to an error on the active ingredients due to the action of an analyst who has since been sacked. It could also have blamed human error and a breakdown in quality control.
Instead, Pan misled TGA by allegedly manipulating the assay results to show that the individual tablets had the right amount of ingredients at the right level.
But a diplomatic Dr McEwen would not describe Pan’s action as a cover-up. He puts it down to a reflection of multiple problems of quality control and production failures.
In fact, it is a lack of respect for the rigour that is needed in the making of medicines. And it is, certainly, an unacceptable commercial practice.
Pan hints that the crisis could have been caused by industrial sabotage.
Its chairman Ross Brown explains that he could not reveal, for legal reasons, the identity of the person under investigation or comment on whether the investigation centres on falsification of documents. The company stands behind its products that do not pose any health risks, he declares.
Whatever the arguments, one thing is certain. The suspension will give Pan’s board of directors and management a chance to change the company’s culture and put a proper system in place.
Pan could possibly regain its manufacturing licence, too, but this, of course, will depend on what influence Selim, who remains a non-executive director with majority shares, has on the company.
Jeffrey Francis is editorial consultant, Australasia-Pacific Media (e-mail: email@example.com )
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