Part 1

TGA Skeletons, WHO Privatised the Regulator?
A three Part Feature Article on who was behind the world’s largest recall. 

Filed May 12, 2003 By Eve Hillary

 [Part 2] [Part 3]

April 29th, 2003 was a cool autumn day in Australia. To the average Aussie it seemed a day like any other. Most tuned into the 6 o’clock news, aware that history was being made in other countries with SARS and the U.S. invasion of Iraq. But few were aware that something of historical importance was unfolding in the “Lucky Country”. To seasoned observers who saw it coming it was nothing short of breathtaking when the near mortal blow to health freedom was finally struck, and for a while, dissenting voices were stunned into silence. Many pundits expected other countries to be the more likely targets but like any interesting social experiment, there was an elegant logic behind the choice. Australians were historically spared the great upheavals of the twentieth century. They seemed more trusting, less suspicious of political and corporate agendas than their counterparts in the northern hemisphere or in Europe where entire populations still recall the spin-doctoring of totalitarian governments under the guise of this or that benefit for the public good. 

The largest, quickest and most comprehensive recall of health care products in world history occurred in Australia following an announcement on Monday April 29th by the TGA that they had served Pan Pharmaceuticals with an order to suspend its operations for a six month period. The company supplied 75% of Australia’s complementary healthcare products such as nutritional supplements in the form of vitamins, minerals, omega oils, and herbal products. Pan also supplied a range of over-the-counter and other drugs, which were sold under various brand names by other companies. Jim Selim, the founder and CEO of Pan is an Egyptian born pharmacist who by all accounts has a passionate belief in natural products and expert knowledge of herbs and supplements. Selim had single handedly built up his company and within 20 years was the largest supplier of complementary health products in Australia. His astonishing success catapulted him onto the world stage as the fourth largest manufacturer of natural health products. Along with this distinction came some unwanted attention from the multi-national pharmaceutical industry, which had been lobbying against natural health supplements and products because of the significant erosion they made into drug company profits. 

Studies show that 60% of consumers have spent some of their health dollars on supplements and natural remedies. Many use natural products to maintain good health or facilitate recovery from various conditions after orthodox medicine has failed, as it often does in the case of chronic illness. Doctors trained in nutritional medicine as well as qualified naturopaths, use supplements therapeutically as an adjunct to orthodox treatments or as wholistic treatments. The science behind natural medicine has been widely denied by orthodox medicine and is largely kept out of medical student’s curricula. However nutrients have been used and studied for thousands of years and there is a large body of valid scientific evidence that shows therapeutic nutrients are highly effective in treating a wide range of conditions. Most health consumers take supplements because they perceive a health benefit and are not even aware that there is solid science behind nutritional therapies. This research is little mentioned in the media, which nearly always portrays nutritional therapies as being solely practiced by unqualified quacks. Media disinformation is issued directly from pharmaceutical company public relations departments on a daily basis through journalists and industry-sponsored doctors embedded in the media and other key positions. (8) This has been occurring for over 40 years and is well documented in the chemical industry archives, documents released through litigation. (7)

Much of the public confusion on the issue results from drug industry misinformation, which frequently refers to nutrient supplements as medicines or even drugs. Nutrients are not drugs. Humans require dozens of essential nutrients such as vitamins and minerals and antioxidants to stay alive and healthy. The body knows how to use these and eliminates the excess as it has done for millions of years. The need for supplements has increased recently, after it has been shown that plant-based foods are now grown on barren and demineralised soils, which do not supply plants with optimum nutrients. Humans then eat nutritionally deficient plants. Orthodox doctors claim the standard western diet contains all we need and additional supplements are ‘flushed down the toilet’. This view appears to be myopic or at least poorly informed, given that 75% of all Australian deaths are a result of lifestyle factors. This includes poor diet and the resulting nutritional deficiencies. 

On the other hand, drugs are mostly synthetic chemicals. There are many drugs that are life saving and beneficial when prescribed responsibly. But the massive proliferation of drugs has given rise to a statistic, which the multi-national pharmaceutical industry attempts to hide. Dangerous or inappropriate pharmaceutical drug treatments and medical interventions have now become the third leading cause of death. 

The “problem” for the pharmaceutical industry is twofold. Healthy people avoid consuming pharmaceuticals. Illness generates profits to drug companies, mainly through their exclusive sale of patented drugs. Wellness and preventative medicine has been less profitable for the multinational drug industry because smaller companies like Pan and many other vitamin companies formulate and sell most of the world’s nutritional and vitamin products. Nutrients and herbs are naturally occurring substances and therefore cannot be patented unless their structure is changed through genetic engineering or chemical processes. Pharmaceutical industry PR departments and industry-funded scientists have been behind unnecessary herb and vitamin scares, citing lack of uniformity or actual danger to persons who take supplements. Subsequently some natural products have been withdrawn from sale while massive drug and biotech multi-nationals work behind the scenes to chemically alter and patent natural substances as pharmaceuticals. In Australia alone the increasing popularity of natural products has deprived the global pharmaceutical market of 2 billion dollars annually. This has brought in its wake an accelerating clampdown on complementary medicine (using natural products). The drug industry is worth trillions of dollars worldwide and it has some powerful friends. 

In January 2003, the TGA moved to recall Travacalm, Pan’s over-the-counter travel sickness tablet when it was tested and found to be defective. After the January recall, Pan discovered a problem with one of its analysts whom the company claimed was responsible for the lapse in quality control over the defective product. The company dismissed the analyst, and set out to correct the problem with its recalled product, while continuing to manufacture its other unaffected product lines. So far the protocol followed normal procedure for a recall, a commonplace occurrence even in the multi-national pharmaceutical industry. 

However, neither Jim Selim nor Pan’s board members anticipated the special attention they were about to receive from the TGA. The company had become used to the regular TGA inspections in the previous few years and neither Pan nor the TGA found any serious cause for concern. In fact, Pan’s vitamin and herb factory had been inspected more often and more rigorously than the Australian-based operations of multi-national pharmaceutical drug companies. However, after January the TGA conducted a number of audit raids on Pan which foreshadowed trouble. In April, the TGA shut down Pan’s entire operation and slapped a class 1 recall over 1369 Pan products which were unrelated to Travacalm. This involved mostly vitamins, minerals and herbal products, which the company supplied to over 75% of the complementary health care market. The regulator cited serious concerns as to the quality, safety or effectiveness of these natural remedies. Class 1 recalls are only issued when it has been shown that the product is likely to cause serious, irreversible health damage or death. By its extreme action of issuing a class 1 recall, the TGA indicated to the general public that the calcium tablet or vitamin C or Echinacea or chamomile or any other of the 1369 natural products they had been taking without any problems, are now expected to cause death or irreversible health damage. Many consumers questioned this logic when they had experienced no adverse health effects from the supplements they had already taken. Those whose suspicions were aroused were even more surprised that the TGA had not given specific information about the nature of the problem with the products. Then Mayne Health, a large health care company whom Pan supplied with health care products, stated that their company had regularly conducted their own rigorous testing of Pan’s product and had not found a cause for concern. The TGA offered no explanation as to why an independent distributor of Pan’s products could find no problem on testing when the regulator claimed there was a life-threatening problem. 

During the week of the shock announcement, the TGA left its responsibilities as a provider of accurate and useful public information, to the daily tabloids who rushed to fill the information vacuum with headlines such as; Honeymoon Ruined, Babies in Danger, It’s a Sick Business, Bad Medicine. By the end of the week the TGA had still not explained the specific problem and which of the vitamin company’s products were affected and in what way. Instead they stood by as the press had a field day whipping up the story while the more vulnerable consumers of health care products, elderly people and young mothers, panicked and imagined all types of horrific scenarios. The interim week saw a run on 5000 health food stores which reported an influx of panicked customers demanding refunds for all manner of products, even those they’d fully consumed, and those that were out of date. Some demanded money for taxi fares. The TGA remained tight lipped about the offending substance that had allegedly rendered these supplements life threatening overnight. Instead, the regulator issued numerous public announcements stating that; “drugs and pharmaceuticals are perfectly safe and persons should keep on taking them”. The NSW State Premier chimed in with his own message to that effect. 

By the end of the week the dailies continued running weekend feature stories about the grave dangers of taking vitamins. The conundrum sent freelance and independent researchers scurrying to their computers to research product recalls. A short search of the FDA drug recall list and medico-legal websites, list thousands of recalls, adverse events and warnings pertaining to drug and chemical products manufactured by multi-national drug and chemical companies. Many of the listed products are known to be either dangerous or toxic to humans and even carcinogenic. Multi-national drug company recalls are rarely given much press, and have never been given as much negative media attention as Pan had received. Even more incredibly, no large multi-national company has ever been shut down by a government regulator after one of its products has been recalled, even if deaths have occurred as a result of using the drug or chemical. This discovery was guaranteed to make any independent journalist even more curious about the TGA and the vitamin company. 

In the second week, Pan stocks plummeted and other companies scrambled to fill the manufacturing gap while their share prices surfed a rising wave. The mainstream media had settled into the role of investigators and de-facto TGA spokespersons, breathlessly informing the public of the “facts” behind the “vitamin scandal”. “Snake Oil Jim Quits..” screamed the tabloids, while the “prestigious” Sydney Morning Herald ran the story; “Tangled Tale of Lucky Jim”, a vicious little expose` of Selim’s daughter and her 1997 battle with drugs. Any parent would consider it a tragedy to watch their child suffer from the disease of addiction, let alone have it published in the newspaper. The journalists Mercer and Stevenson used a psychologist’s report to speculate on Jim Selim’s shortcomings as a parent. Hardly a need-to-know issue for the Australian public who had still not been informed as to the results of the regulator’s testing of the 1369 urgently recalled products. Not surprisingly, Jim Selim voluntarily resigned as CEO from his own company, amidst one of the most vicious tabloid vilification campaigns in the history of the Australian press. 

While grannies thought they had been poisoned, Australia’s investigative journalists wrote about interviews with disgruntled employees who thought they should have had longer breaks and the production should have been slower at the vitamin factory. The dailies stated opinion as gospel while offering no real facts from the TGA. While the thinking public waited for the facts, young mothers still thought they had poisoned their babies. The tabloids made fun of Jim Selim and columnists wrote ditties about vitamins and herbs being “eye of newt”. Embedded industry-sponsored TV journalists worked feverishly behind the scenes to spin horror exposés about herbs and vitamins that were screened within a week of the breaking news. And still no one had suffered any adverse effects from having taken vitamins. Embedded “experts” emerged from the closet with their editorials, published under the guise of objective articles. Still the TGA remained silent about the exact reason why the natural products were classed as being capable of causing death. Pundits assumed TGA was checking all recalled products just as they had checked Travacalm and made public the exact nature of the problem. 

By the end of the week Jim Selim, once a man with a zest for life, had been forced to leave his home after journalists crawled all over his garden by day and night. They interviewed his neighbours, one of whom complained that the Selim family had visitors who banged the gate when they left. The other complaint was about the noise when the family swam in their pool. The facts gleaned by the reader from this in-depth investigative journalism were that the Selims had friends and they indulged in occasional exercise. By week’s end the Selim family retreated to parts unknown, amidst Jim’s friend’s concerns that “he is in a very bad way.” 

While the media was beating itself to death with the vitamin factory story, a little known posting appeared in an obscure place on the TGA website. The regulator is also in charge of being a public watchdog with respect to food, chemicals and consumer items. On the same day as the TGA recalled Pan products, they also issued another recall. A smallgoods company packaged a large quantity of ham, which was found to be contaminated with bacteria known to cause serious food poisoning, which sometimes results in death. The media never mentioned this, and there were no public press releases issued by the TGA. 

At the end of the second week following the world’s largest recall, the TGA had still released no results of their product testing to Australian consumers or the thousands of businesses that relied on accurate information. But many of the 5000 or so Australian health food store proprietors were about to start the cascade into insolvency. To hasten the process, they were forced by the consumer watchdog ACCC to issue consumer refunds when they had no guarantee of reimbursement by the now ailing manufacturer. Health food shops were left saddled with the difference between the wholesale and retail price, which they had to find out of their own pockets. With their backs to the wall they still had precious little by way of an explanation. However, TGA did issue clear instructions to clear shelves of recalled product. Now, virtually overnight natural products disappeared leaving many shops bare. 

The largest mountain of vitamins, minerals, oils and herbs in the world was hurriedly designated for destruction by the Australian Government in a special location and using a special process usually reserved for toxic waste. The evidence is destined for destruction. The TGA has still not informed the public as to why their natural products were classified as being deadly, when no one had previously suffered adverse effects. The regulator has released no test results. It is not known if tests were ever conducted. When the mountain of vitamins finally rests in its mass grave, incinerated and entombed as the remains of what the Australian government regards as toxic waste, we will never know. And the epitaph on the headstone could well read; “Here Lies Health Freedom”. 

Among the mystery and intrigue surrounding this historical event, one thing appears to be certain. Had any test shown a lethal toxicity supporting a class 1 recall, the TGA would have told us by now. 

Unlike some issues that rest in peace, the ghost of this recall will haunt the government for years to come. The story of the recall started years ago in a bustling European city. But first, a little more about the regulator.