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  Tainted pills May 4, 2003 Reporter : Helen Dalley Producer : Paul Steindl and Nick Rushworth  For the qualified analytical chemist, the scene at the Pan pharmaceutical factory in Sydney's south west was hard to believe. Newly employed to work on the production of tablets in 1990, he says powder dropped on the floor during the production process would be swept up and dumped back into the machines. This was not, he says, a sterile, controlled environment. Workers would walk through the powder in their street shoes, on the way to and from the toilet. "This was a regular practice every day, and this was the culture of the company," he told Sunday.In further serious breaches of good manufacturing practice, he claims, the company would run two different product lines in the same room, risking cross contamination of the drugs. Machines were not cleaned properly. Alarmed and disgusted by what he saw, the chemist reported his concerns in writing to the Health Department, and was assured that the Therapeutic Goods Administration would investigate. Exactly what happened to the promised TGA investigation is unclear. This week Pan founder Jim Selim claimed: "We have been audited 25 times in 29 years and never had any problems." Not surprising, if the practice observed by Sunday's whistleblower is any guide. He claims the TGA would inform the company in advance they were going to pay a visit. There were no surprise inspections, so by the time the TGA arrived, "everything had been cleaned up neat and tidy." In an extraordinary interview with Sunday's Helen Dalley, the TGA's principal medical adviser, John McEwen admits that until the Travacalm disaster, the TGA did give Pan advance notice of impending audits. "We operate generally on an element of trust", he said, "because one needs the cooperation of the staff. If you’re going to go through a pharmaceutical plant and ask to observe a production run of tablets, if you want to have access to their computers to get old batch records, you need their cooperation." That policy of giving Pan the benefit of the doubt is all the more remarkable in view of the company's dubious history. In 1992, the Pan group imported 9 million capsules of evening primrose oil from an unaccredited company in Thailand, instead of the approved Canadian supplier. The batch was contaminated with a non-toxic charcoal. The TGA only discovered the switch when it examined samples at the Pan offices. In 1996, the company was found guilty in the NSW District Court on 13 counts of illegally supplying and exporting therapeutic goods. Judge John Nield fined the company a record $280,000. That judgement was later overturned and a new trial ordered. But the new trial never took place. In 1999 Pan Laboratories went into voluntary liquidation, leaving no legal entity for the TGA to prosecute. The TGA nows says it had no option but to approve Pan Pharmaceuticals' request for a manufacturing licence. It wasn't Jim Selim's first run-in with health authorities. The NSW Pharmacy Board found him guilty of professional misconduct in 1976. The Egyptian-born pharmacist was banned from practising for three months after he was found to have substituted lactose for paracetamol in cold tablets. He was also reprimanded for manufacturing throat lozenges containing a lesser quantity of certain drugs than laid down in the formula. Selim was reported to have explained in his defence that only a small quantity of paracetamol was available at the time and the cold tablets were needed urgently because of a flu epidemic. In 1985, in the Sydney Local Court, Selim was convicted on four counts of the Poisons Act for improper supply and storage of drugs when he was a pharmacist. These early hiccups had little impact on the rise and rise of Jim Selim. He had launched his company in 1974 with just four employees. That would grow to 230 staff as he built a product line of more than 4000 tablets, capsules and soft-gels. Selim's personal fortune grew to more than $200 million. Then, on January 16 this year, reports of severe reactions to a popular travel sickness pill began to arrive at the TGA's headquarters in Canberra. An elderly woman had begun hallucinating after taking Travacalm. Other victims were complaining of dizziness, blurred vision and being unable to stand properly. By the end of January, 19 people had been hospitalised. In one case, according to Parliamentary Secretary for Health, Trish Worth, an airline passenger had tried to jump out of a plane after taking the pills. TGA tests on Travacalm showed a wide disparity between tablets. In fact, some tablets contained none of the active ingredient, while others contained up to 700 percent. Earlier this week, the TGA recalled 219 Pan products after an audit revealed the company had falsified test results, substituted raw ingredients and failed to clean equipment between batches of products. The TGA suspended Pan's licence for six months and, in an unprecedented move, warned all Australians to stop taking non-essential alternative medicines until all brands sourced to Pan had been identified. Eager to provide a scalp to a hungry media, Pan announced that a "rogue analyst" had been sacked and that a more senior employee had also been stood aside pending an investigation into his conduct. But even then, Pan director Ken Baxter ruled out an apology to consumers. "At this stage," he said, "I don't think an apology is required." For the hundreds of Australians who have become ill after taking Pan products - and for the many thousands who have lost money from the debacle - the company's arrogance is hard to stomach. Despite claims that ill-effects from the contaminated Travacalm tablets are short-lived, evidence is mounting of serious, debilitating and long-term injury among some victims. As Sunday's investigation reveals, at least one victim appears to have been left partially paralysed. Neville Paterson says he took one tablet before a fishing trip just last month and soon found himself feeling giddy and unable to speak. Six days later he was admitted to hospital after collapsing in the street. Since then his face has been paralysed, leaving him unable to close one eye. Pan Pharmaceuticals is now facing potentially crippling civil action, as several of the companies for which it manufactured product seek to recoup costs from the recall, and victims of Travacalm queue to join class actions for damages. And the company's legal problems don't end there. Sunday has confirmed that the TGA is currently conducting a criminal investigation involving possible drug counterfeiting charges against the company and certain employees. Not a single company executive or board member would agree to be interviewed by Sunday. This week, as his empire crumbled around him, Jim Selim was forced to quit as chief executive. More than 1300 product lines have now been recalled. The list is still growing - and so are the questions. LINKS Products affected Details of the recalled products are on the Therapeutic Goods Administration website, the Product Recalls Australia website. Consumers can also call the TGA's toll-free helpline: 1 800 220 007 (8am-8pm, 7days) or a hotline set up by Pan Pharmaceuticals on 1 800 190 007. Refunds The ACCC says consumers with proof of purchase are entitled to a refund from point of sale. Those without proof of purchase should call the company whose name is on the product or the TGA hotline. Workers entitlements Details of workers entitlements at Pan Pharmaceuticals Other links The Complementary Healthcare Council (CHC) is the peak body representing the overall complementary healthcare industry in Australia. Herbal Medicines Research and Education Centre Click here for transcript |
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