Every day last week, the newspapers carried full-page lists of medicines and dietary supplements recalled by the Therapeutic Goods Administration (TGA), after it suspended the manufacturing licence of Pan Pharmaceuticals for six months on April 28.
Pan produces 70% of Australia's herbal vitamins, cold and flu tablets, and nutritional supplements. It exports its products to more than 40 countries.
The TGA suspended Pan's licence following a four-month investigation of the company's products. The probe was triggered when 19 people were admitted to hospitals in January after suffering adverse reactions to the travel sickness pill Travacalm, made by Pan.
The TGA initially identified 219 Pan products for recall. However, by May 2 this had expanded to 1369 products. The investigation sparked serious concerns about the safety of Pan products. The company was found to have used substituted untested ingredients in its products, failed to clean machinery properly between production batches and systematically and deliberately manipulated quality control test data.
"These things should have been found out years ago when they were a smaller company because they were doing it back then and they are doing it now", Leonie Kruger, a former Pan employee, told Singapore's Channel News Asia.
The company initially blamed the problems on a "rogue laboratory analyst", who it accused of falsifying test results. However, it provided no explanation for the unreliability of its manufacturing processes.
On April 29, Richard Obedoza, a machine operator at the Pan plant in south-west Sydney, told the media that Pan managers pressured production workers to "rush, rush, rush, just keep going", even if raw materials for medicines had not been tested or had failed. Workers raised concerns and hesitated to sign off on products, but backed down after management pressure.
Obedoza said that workers were under intense pressure to make 5 million tablets a day, "but we can't make that if we clean the machine properly". He said that if the workers failed to produce 5 million a day they would be "screamed at" by Jim Selim, Pan manager and chief executive officer.
On May 1, Selim resigned as manager and CEO, though he remains on the company's board of directors and holds 53% of Pan shares.
Selim has had a history of regulatory run-ins since he founded Pan in 1974. In December 1976, his pharmacologist's licence was suspended for three months for making, three years earlier, paracetamol tablets that did not contain any paracetamol. In 1996, Pan Laboratories Pty Ltd was fined $280,000 for supplying and exporting unapproved therapeutic goods.
"We've been waiting for something like Pan to happen for years", said Dr Jan Howes of the University of NSW's department of clinical pharmacology. "This industry has been like an accident waiting to happen because natural therapies are not under any real scrutiny", Howes was quoted as saying by the May 3 Sydney Morning Herald.
Howes' opinion was supported by John Dwyer, chairperson of a NSW Health Department committee that is looking into consumer protection and complementary health care. Dwyer accused the TGA of "being part of the problem rather than the solution", according to the May 3 SMH. "The TGA is poorly resourced and a weak organisation in terms of setting standards and documenting if those standards are not met."
Dwyer continued: "It is like charging the guy with manslaughter after the baby is dead. Had the manufacturer been subject to continuous quality control it would not have happened. The emphasis should be placed back on the manufacturer to demonstrate quality control."
While the Pan scandal raises questions about the adequacy of government regulation of the pharmaceuticals industry, it also highlights the dangerous irrationality of the capitalist system — a system in which the health needs, lives and livelihoods of the vast majority of people are subordinated to the relentless drive to maximise corporate profits.
The livelihoods of Pan's employees and the socially useful productive facilities that their labour has maintained should not be allowed to be destroyed because of the greed of the firm's capitalist owners. The company should be taken into public ownership and operated to meet the public's health needs, with the safety of its manufacturing processes verified by a quality control board elected by its employees.
From Green Left Weekly, May 7, 2003.
Visit the Green Left Weekly home page.