Pan Pharmaceuticals - if it ducks like a quack

It's "Good News" week!
Someone's dropped a bomb somewhere,
Contaminating atmosphere,
And blackening the sky.

Do you remember Hedgehoppers Anonymous? Neither does anyone else, but everyone remembers their one big hit record. It really was a good news week when someone in the shape of the Therapeutic Goods Administration (TGA) dropped a bomb on Pan Pharmaceuticals, Australia's largest contract packager of "alternative medicines" (and one of the largest in the world), and suspended their manufacturing licence for six months. Everything manufactured by them for the previous several months was ordered to be recalled from stores because the quality control at Pan was found to be, well, non-existent. In their defence, I suppose you don't need to check the quality of the manufacturing process when you can put any old ingredients into bottles and pills and do your product and material testing by just typing numbers into a computer

Predictably, the response of the alternative medicine community has been to attack the messenger. The TGA, which oversees the quality of medical devices and pharmaceuticals in Australia, has been criticised for acting both too hastily and too slowly and even for existing at all. The final spark which blew the Pan fuse at the TGA was a product called Travacalm, used for motion sickness. It has been pointed out to me that this was not any alternative product, but was a pharmacy-only product with the highest level of registration at the TGA. Yes it was, but when you look at something with the highest classification and you can find tablets in the one package which contain between zero and 700% of the stated active ingredient (overdosing of which chemical can cause temporary psychosis and hallucinations), you have to wonder what was going into the many hundreds of placebos and snake-oil pills that Pan was making for their clients and which had a lesser classification that did not require any proof of efficacy.

One of the diversionary tactics used by the alternative supporters was to concentrate on Travacalm as if this was the only problem found at Pan, and then to try to either prove that it wasn't anything alternative or that there was no real problem anyway and the whole affair was just a smokescreen to allow the destruction of the supplement industry. Truth was not a necessary component of much that was said, and neither, as it happens, was knowledge about herbs and "natural" medicines needed. I found it ironic that I should be placed in the position of telling alternative believers which plants were used to produce which natural drugs. As an example of this, one person who claimed to be knowledgeable in such matters commented that there was no mention of the active ingredient, hyoscine hydrobromide, in her herbal reference books. Perhaps she wasn't looking under "henbane" for the name of the plant it comes from, or under "scopolamine" for the name that it sometimes goes by.

One particularly egregious piece of lying was by someone who sent a message to a US-based web site saying that Travacalm was only available on prescription (it has the words "Pharmacy Medicine" printed on the box), that Pan made 50% of all prescription drugs in Australia, and that only the alternative medicines made by Pan had been recalled. I imagine that the writer believed that nobody outside Australia could check on the facts, which are that "Pharmacy Medicine" does not imply prescription only (it means that sales are restricted to pharmacies only, not supermarkets and other outlets), Pan made very few prescription drugs, and almost everything that they made was recalled. Suggestions were made in several places that there had been no complaints about any of the supplements made by Pan so they must have been perfect, but the facts were that the rot of poor manufacturing practice was endemic at Pan. There were also claims made that Pan were totally unaware of any concerns that the TGA had until the recall was ordered, and it came as a surprise. The truth is that the TGA had been at Pan since January and had had to seize computer equipment to stop records being destroyed.

A strange aspect of much of the opposition to real medicine is that people make statements which are either ridiculous or can be disproved in minutes, much like the example above about the Travacalm labelling. I am not sure whether this is just contempt for the audience or pathological lying, where the truth simply does not matter. An example came from a regular spokesperson for the alternative industry, who claims to be a journalist and a professional writer on health matters. In a press release, this person said that the recall was announced on the 29th of April (it was the 28th, and the wrong date was used twice so it wasn't a typo), that Pan's "stocks plummeted" in the second week after the recall and other companies' shares rose (Pan shares were suspended from trade on the day the recall was announced so they went neither up nor down in the following week. The writer forgot to mention that the company whose shares benefited most was Blackmore's), and that on the same day as the Pan recall, the TGA had ordered a recall of some packaged ham.

Ham? The TGA ordered some ham recalled? I immediately checked the ham I had bought for my lunchtime sandwich to see if had an AUST L or AUST R number (I refrained from making jokes about "curing"), but there was nothing there. This "journalist" was so stupid (or so careless) that she couldn't tell the difference between the TGA and the federal Health Department. Still, what are facts when there's quackery to be defended? For the record, the last three recalls ordered by the TGA at the time of writing were Difflam - C Alcohol Free Solution (February 4), Pan (April 28) and Kotex U tampons (May 30). No ham.

The press release went on to talk about how the Pan recall was part of the great UN/Illuminati worldwide Codex conspiracy to destroy alternative medicine. Evidence of the conspiracy was that the Geneva office of the World Health Organization had been notified of the Pan recall. (Did I mention that some of the alternative supporters are nuts? It doesn't seem to worry many of them.)

Another claim was that the TGA had to be lying about the problems at Pan because it was not possible to have a single packet of medication with the range of ingredient proportions that had been claimed (0-700% in the one package). I was told that there was no way this could happen because the tablets would fall apart and have holes in them if the mixing was that bad. I asked someone at a company which sells packaging machinery for food and pharmaceuticals and his reply was that Pan was "like the Keystone Kops", and that it was very easy to have this sort of range if you didn't care about quality, only the time and cost of manufacture. There are two stages where time and money can be saved in this sort of manufacturing process - machine downtime and ingredient blending. We already know that Pan was ignoring correct cleaning procedures when switching machines between products, so it is not too hard to imagine that saving a bit of time in the mixing stage might cause some variability in a product where one kilogram of active ingredient is spread across five million tablets.

One good thing that might come out of this debacle is that the public might start to realise that TGA approval to sell something does not imply that the product or device does anything useful, or even anything at all. There are two levels of approval - "registration", which requires evidence of safety, quality, and efficacy, and "listing", which only requires quality and safety. Both are required to have truthful labelling. I was taken to task because I stated in a radio interview that there was no requirement for "complementary" medicines to have any effectiveness at all, and I was sarcastically asked if I had bothered to read the TGA web site before I went on air. Just for reference, I will quote what the TGA says. You will see that most complementary medicines can be sold without any proof that they work.

"Products assessed as having a higher level of risk (prescription medicines, some non-prescription medicines and medical devices) are evaluated for quality, safety and efficacy. Once approved for marketing in Australia these products are included in the ARTG as 'registered' products and are identified by an AUST R number.

"Products assessed as being lower risk (many non-prescription medicines including most complementary medicines and low risk medical devices) are assessed for quality and safety. Once approved for marketing in Australia, these products are included in the ARTG as 'listed' products and are identified by an AUST L number".

Australia is about to embark on a great experiment where many people are not going to be able to get their snake-oil supplies for some months. I can confidently predict that we will not see the return of the days when people went through the streets calling "Bring out your dead", like they did in the heyday of "natural" medicine.

This article by Peter Bowditch appeared in the June 2003 edition of the Skeptic, the journal of the Australian Skeptics