Pan Pharmaceuticles

[Bushmiller]

Today Jim Selim, formerly boss of Pan Phamaceuticals, was awarded a second court settlement. In the first in 2008 he received $50 million. Today he was awarded an additional $67.5 million.

The interesting issue is, that despite this award, the government has not addmitted error, guilt, responsibility or any other liability over this matter.

The total award is still only approximately one third of the estimated wealth of Selim's original company dating from 2003, which was sold in a fire sale for $20 million.

My question (arguably rhetorical) is this: " Was there a conspiracy to bring down the alternative/natural industry by self-interested parties and was the TGA (Theraputic Goods Administration) complicit in Pan's downfall?"

If you would like to refresh yourselves on the sequence of events and the basis of the recall on Pan's products, you might find this link helpful:

http://members.iimetro.com.au/~hubbca/pan.htm (http://members.iimetro.com.au/~hubbca/pan.htm)

Regards
Paul

[Sebastiaan56]

I think that like most other government agencies that take advice or rely heavily on industries for technical support the TGA is vunerable to undue influence from industry bodies. The fact that Pan was so comprehensively destroyed and Selim is having his day in court is proof IMO.

But it happens everywhere. Another great example is the Australian Dietetics Association. They are sponsored by Nestle, Fontera and the Meat and Livestock Corporation. Their website is an ad for the dairy and meat industries. Another example is the research into the effectiveness of speed cameras.

[Bushmiller]

The dreaded lobbying (read self interest/greed):(!

Regards
Paul

[Bushmiller]

Lots of viewing but...

I thought I might up the ante a little with some exerts from the link. It highlights the anomaly of a class 1 recall, which in this instance extended to thousands of products, not just the travel sickness pills in question.

Not only that, class 1 recall is used when there is imminent chance of death!

Compare also to the TGA's treatment of VIOXX, which is looking as though it may have killed an extraodinary number of people. This is from Wikipedia:

"As of March 2006, there had been over 10,000 cases and 190 class actions (http://www.woodworkforums.com/wiki/Class_action) filed against Merck over adverse cardiovascular events associated with rofecoxib and the adequacy of Merck's warnings."

and this is from the previously posted link:

"Moreover, the vitamin and mineral supplements, which had caused no known ill effects, were classed by the TGA as necessitating a class 1 recall, meaning the regulator claimed the natural products would "cause death or permanent injury".

and

"TGA bias was particularly evident by the manner in which the regulator conducted future recalls. Interestingly, the regulator conducted a class 2 recall on VIOXX; a drug manufactured by drug giant Merck - a drug which did cause 55,000 confirmed deaths and over 180,000 confirmed injuries to Americans alone. A Class 2 recall meant the TGA believed the "defects could cause illness... but are not class one" That meant that the regulator claimed the drug could not kill or disable anyone, which was an obvious and self evident falsehood that put the community at risk. (6)"

I have to say that the figures may be a little exaggerated, but the point is that even a single death would be far more extreme than the Pan Pharmaceuticles case.

My take is that there is a place for both "natural" and "engineered" medecins and that no company, government or individual should be permitted to unreasonably restrict their development and availability:((.


Regards
Paul

[Master Splinter]

Or for the other side of the story...

http://www.ratbags.com/rsoles/comment/pan.htm

In brief - Travelcalm was a non-alternative medicine product. The active ingredient is hyoscine hydrobromide (scopolamine).

Hyoscine hydrobromide is one of those 'real close to needing a doctor's prescription' drugs, and is a pharmacy only product.

The recall commenced due to concerns over numerous reports of symptoms such as dizziness, anxiety and hallucinations from people taking the drug. Nineteen people were hospitalised, including one who was halucinating so badly he tried to jump off the plane he was travelling on.

The product, and Pan Pharma's process control was investigated.

Samples of Travelcalm showed hyoscine hydrobromide content between 0 and 700% of the stated dose.

Therapeutic Goods Administration identified serious problems with Pan's manufacturing process, including issues with the base materials and how they were tested (in some cases not at all), the cleanliness of the machinery, and inadequate change over procedures between manufacturing runs. There were also suggestions that routine test results had been manipulated.

While recalling all of Pan's line was possibly over-the-top (the vast majority of homoeopathic/alternative treatments have no therapeutically active ingredients as such and can only be overdosed on only in a 'food' sense), there was the alternative of people dying due to Pan's poor process control and lack of documentation. Think of the 'no nuts' production run occasionally getting nuts as the machines weren't cleaned or a couple of bags of nuts got in the mix because a worker forgot that this was the no-nuts run.

But drug companies lie and hide results too, which makes me think that more CEO's should be up for prison time if things go astray while they are in charge. (the only way I can think of justifying a salary of over a few million for a CEO is if they are sh_t-scared of ending up in jail during the entire time they are CEO).


But to answer your question, no, I don't think there was a conspiracy to shut down alternative medicine by big pharma - it was probably more like this:
TGA dude: "...the place was a mess, spilled product would regularly be scooped off the floor and put back into production, sometimes it was stuff from the previous shift, stuff...

Politician: "So there were dirty manufacturing processes?"

TGA: "Yea, and stuff shipped in was sometimes the wrong stuff, you know, wrong strength, but they'd have the same quantity so they'd use it anyway - they didn't test and adjust their mixing, so product was too strong or too weak or whatever."

Pollie: "No process control?"

TGA: "Nup, and stuff swept up from last shift could be sugar or cyanide, they didn't ask, just swept up and chucked it in the current mix."

Pollie: "So is anyone going to die?"

TGA: "Errrr, dunno, probs not, cuz most of that stuff is really no worse than salt or pepper."

Pollie: "Can we be sure of that?"

TGA: "No effing way I'd put my name to a statement saying that, dude, there's no documentation or delivery dockets and people have said they'd even make sh_t up when doing the occasional audit trail, so anything is just a guess."

Pollie: I&%ER%$IY&^. Can't have dead voters, the Daily Tele would have me labelled 'the poison pollie' before the middle of the week."

TGA: "Sucks 2 be U, dude, hard call."

Pollie: (silently to self) "No, sucks to be you, it's the TGA that's going to keep my name out of the papers."

[Bushmiller]

MS

Interesting take; at least partially on the other side of the story. I was wondering about the source of your information. Inside info either factual or anecdotal, attended court hearing etc.

Not being confrontational here, just interested.

My primary, but not solely, reference was the link I attached. My gut feeling, which is totally inadmissible in a courtroom, is that the drug companies saw their empires being eroded and they react badly to a perceived threat.

Many drug company products have very unfortunate side effects: Some are declared and some are not. The VIOXX issue is just an example. My point here is that they are hardly sqeeky clean themselves. Possibly Pan needed a shake up. Did a drug company get a shake up?

Those that think drug companies are ethical and beyond reproach should have a read of the thread below posted by RSSER.

http://www.woodworkforums.com/f136/why-you-should-wary-about-medications-130921/ (http://www.woodworkforums.com/f136/why-you-should-wary-about-medications-130921/)

Back to the judgement. My understanding is that:

The travel sickness product in question had already been recalled ( and I would accept that was possibly the right thing to do.)
Over 1800 products were recalled as a follow on.
Pharmasceutical products were also made by Pan for drug companies, but they were not recalled.
VIOXX, which had allegedly killed people, was only classified as class 2.
Travelcalm was classified as class 1.

Was the TGAs action over the top? Were they manipulated by big business? Was there an agenda to bring the alternative medicine industry into disrepute?

If the answer to those questions is "No," why have the courts awarded damages in favour of Pan? It would appear to me that there are a number of inconsistencies in the behaviour of the TGA and if that is indeed the case I am not really surprised that damages have been awarded.

I am sorry that Jim Selim has had to wait 8 years to receive justice (probably still only partial), that his business was destroyed, that those in the public who relied on his products were denied access, that the stigma flowed on to other companies and individuals and finally that he still has probably not received full compensation.

I do not like to think that an individual or in this case a small company is taken advantage of by a bully entity. It make me seethe.

See my footnote:rolleyes:.

Regards
Paul

[ian]

Couple of points

1) this last case was a class action by Pan's customers, not Pan itself.

2) there was no court judgement as such, the parties (Govt & plaintiffs) settled without an admission of culpability by the Govt

3) settling before or during a trial is fairly common practice for civil cases, in many instances the settlement represents a judgement by teh parties that to go through the trial process will cost a hell of a lot more and possibly achieve a worse result

4) Jim Selim's "day in court" happened a couple of year's ago. I'm not sure if it went to a trial judgement or also resulted in a settlement

5) Friends with experience in pharmacy and food processing confirmed at the time Master Splinter's suppositions (above) about Pan's mixing processes leading to highly variable product.

6) most likely we, as a community, should be more concerned about the technical competance of bodies like the TGA. My experience of other Commonwealth agencies is that, at the senior decision making level, they are predominately staffed by lawyers and economists who are on the premotion roundabout -- stay 9 months to a year and then move on to a job in another department -- and accordingly know little about the organisation they are currently in and care even less about the technicalities associated with the decisions they need to make. From their perspective the most important thing is to keep your nose clean, look like you're doing a good job and get out before the proverbial from your decisions hits the fan

[watson]

From their perspective the most important thing is to keep your nose clean, look like you're doing a good job and get out before the proverbial from your decisions hits the fan

Sounds like the Army :doh:

[Bushmiller]

From their perspective the most important thing is to keep your nose clean, look like you're doing a good job and get out before the proverbial from your decisions hits the fan

Ian

I hate buzz phrases, but "lack of accountability" does come to mind.:(

If this last case was a class action it means that poor old Jim is more out of pocket than I thought.

Regards
Paul

[Bushmiller]

Sounds like the Army :doh:

Just slightly aside from the main issue, I always trot out a certain story when the army is mentioned.

I was at school (some time last century) and having a careers talk from a bloke who had been in the army.

He told us of the time he had the temerity to ask his sargent major why he had to do something.

The SM replied,

"You 're in the army son. You're not here to ask why. You're here to B***dy well do!"

Since that day statements from the army have held little credence with me.:)

Regards
Paul

[Master Splinter]

I too have little real trust in drug companies; they've blotted their copybook many times and I probably won't start trusting them more until their research budgets are larger than their marketing and lobbying budgets.

However, despite how depressingly low a bar pharmaceutical company business methods set, they are still considerably more ethical than the homeopathic/naturopathic businesses which essentially sell anything that anyone has even remotely claimed has fixed some real or imagined illness.

For example, in that site link you provided, there are all sorts of unusual beliefs, such as:


colon cleansing,
vaccines are bad, (m'kay),
homoeopathy (clear winner in the woo brigade),
cell salts (including stating that you can get sodium phosphate and sodium sulphate from sodium bicarbonate?????),
Pasteur recants germ theory on his deathbed (http://www.ratbags.com/rsoles/comment/pasteur.htm)
the neurophone - a device which allows the profoundly deaf to hear 'by transferring sounds directly into the minds of the deaf person, thus bypassing the ears' (it's being suppressed because it might clue people up about government mind control programs)

not to mention UFO's, antigravity, free energy machines, fuel savers and a whole list of other topics that best fall under the banner of 'research done by people for whom research is equivalent to 'makin' sh_t up'.

(I was upset, though, that ear candling didn't make it onto that site!)



And my source of information for my original comment - the internet (as per my link), supplemented by memory of the case from when it was news.

Also supplemented by having worked in government departments that have to jump for their minister and knowing the stupid things that have to be done to keep the minister happy.

For example, back when FACSIA was called Social Security, there was a tabloid investigation that found out that some tiny, tiny percentage of OAP's with particular, once-off circumstances were getting paid some trivial amount (under $10) a week more than their peers.

Outcry/outrage etc, ministers office wants it fixed. Minister's office are advised:

Option one - do nothing, the overpaid group are essentially in palliative care for degenerative diseases and not expected to be alive in 18 months time, so any overpayments could be recovered from the estate, but the cost of recovery in staff time is expected to be greater than the dollar value of the overpayment.
Option two. Hard code the reference numbers of the recipients into the processing system to flag them for an extra calculation step (ie remove $overpayment) before their cheques are printed. This is a 'cheap' option in programming time but expensive in follow up when DSS/the ministers office gets phone calls asking why their pension cheque is smaller this week, as well as when recovery action starts to recoup the overpayments already made.
Option three. Re-write that part of the benefits processing system to eliminate the root cause of the overpayment. Estimate 3-6 months to identify cause, re-write, prepare test pack, test, test against other cases so you are not breaking someone else's pension by accident, and schedule for inclusion into the production system. Most expensive option, estimated cost exceeded the money saved by at least 100%.

Of course, the minister's office wanted option three, as then the minister could say that he had taken steps to make sure this didn't happen again.


Oh. It's probably worth noticing that Jim Selim died last year of leukaemia, so it's a pity he never heard that all cancers could be cured by sodium bicarbonate treatment (http://members.iimetro.com.au/%7Ehubbca/bicarb.htm).

[Bushmiller]

MS

Thanks for all that. I have to agree that sometimes the alternative health groups are their own worst enemy. It doesn't help that they attract a good share of charlatans and nutters. I have been fortunate in knowing very good practioners, but not all are the in the same category. I suppose the same is true of doctors and drug companies.

I didn't know Jim Selim had died. I heard about the recent judgement on ABC radio and it rekindled the disgust that I had back in 2003. Everybody should be accountable, but there should be an even-handed justice.

Thanks again for constructive criticism.

Time for a herbal cuppa :rolleyes:

Regards
Paul

[AlexS]

May I congratulate all the participants in this discussion on presenting their no doubt strongly held views in a polite and rational manner.:2tsup:

[watson]

:whs:

[hughie]

Well for me, I had at that time a close contact within at a senior level.

This what came across; The basis of the complaint initially was around completed paperwork in procedures and the whole claim was to do with one box of travelcalm tablets.
However the entire range was confiscated[ some 1500 products ] and no testing was allowed on any of these products.

make of this what you will...........

[artme]

Remember Midford School Clothes? Same approach by a different Government organization. Find 'em guilty without a trial and bugger the consequenses.

[underfoot]

Remember Midford School Clothes?
umm,,,no...were they recalled for making schoolkids sick?:oo::D

[artme]

Customs and Taxman , between them, drove him to the wall. Lots of chicanery on their part from what I remember.

[damian]

As has been said great to see a polite rational discussion. I agree with most of what's been said on all sides, but I would like to comment on this:

vaccines are bad, (m'kay),

While I happily acknowledge they have prevented a lot of disease there are also a lot of people who have been disabled and even killed by them. Vaccines are not all good. If you go looking you'll find a few parents with dead kids (yes in aus) who are not as impressed with vaccines as they might be. I am not suggesting they are universally evil nor that the ill effects are particularly common. I resent both the panic mongering of the hippie/conspiricy brigade and the attempts by others to sweep the ill effects under the carpet. I am in favour of informing people so they can make up their own minds.

At the risk of hijacking this thread I have recently been amused at the indignation of the press at the anti carbon tax rally the other day. How quickly they have forgotten the dredful slurrs leveled at Pauline Hanson a few years ago, and the smirks they wore throughout.

Regarding Pan, while it is amusing to speculate on conspiricy I rather suspect the alternative theory of government incompetence has more legs. They certainly stuffed up the process and anyone who has anything to do with the inner workings of the modern australian government wherever it seats itself will know what a complete shambles it has become, particularly in the last 15 years.

2c.

[rrobor]

Well well well now we come down to the nub. Vaccines lets look at them. I have uncle Alex Died as a child of ditptheria. I have cousin Eileen died at 6 of hooping caugh. My aunt, her mother
lost a child she was carryring and she developed a heart condition I suspest due to stress. May I use the words of Oliver Cromwell and say this. From the bowels of Christ, please I beseech you to consider what you do. You who have not lived through polio outbreaks and the like dont know the horrors they cause. Please Please Please dont let idiots sway you. There will always be a price to pay if you vaccinate, but that price is miniscule to what was in the past.
Cattle in UK had a ratio of 30% with active TB within 20 years that was down to below 1% as was the population, Please dont go backwards into the dark ages and the horrors that brings.

[Bushmiller]

Like I said in a previous post, there is a place for natural remedies and a place for modern engineered drugs. We shouldn't be particularly accepting of either, but in practice that is exactly what we are. We accept the physician's recommendation and he in turn has accepted the drug companies recommendation.

Equally we accept the naturopath's recommendations. Now with the internet, choice and investigation are more readily available (but still not infallible) and we should question the remedies offered to us. It keeps everybody honest. Well maybe.:rolleyes:

Vaccinations, immunisation innoculations, whatever you wish to call it, is possibly one of the triumphs of modern medecine. I am trying to think of the terrible illnesses that have been all but eradicated by this technique, in the western world at least. I am sure I will miss many. Please feel free to add them:

Smallpox
TB
Rubella (German Measles)
Polio
Hooping cough
Diptheria

These have had a huge positive impact on health. However again greed takes over and in recent years there have been moves to vaccinate for the common cold and flue. Not really successful to my mind and the following year you have to have another one because the virus has mutated. Better to build up antibodies of your own. The body when it is in good nick does a pretty good job of fighting off disease. The exception to this I would make is where a person already has a reduced immune system and is consquently already at risk.

Do we really need a flue vaccine or do the drug companies really need a flue vaccine and are the good old government brainwashed into believing their people must have this?

I know this has moved off the Pan subject slightly, but it illustrates the effect of successful lobbying and as MS stated the covering of one's own a**e by officialdom.

Regards
Paul

[TP1]

Make no mistake folks, there was no conspiracy here. I have had experience with the TGA on behalf of clients as well as other government agencies. I have seen instances where over officious public servants have a complete disregard for the impact they have on commercial enterprise. Why don't we hear about it more often? Well, because that sort of thing is not newsworthy until people lose jobs on a big scale - like Pan Pharmaceuticals. No one otherwise gives a rats if a reasonable sized company loses big money because of the actions of over zealous government agencies. If I remember correctly, The TGA even made public statements about closing Pan down.

Artme's reference To Midfords ( clothing manufacturers) was spot on. In that case, an over zealous Customs department raided the company removing all their records and seizing all their stock. The company, which was later found to be law abiding, was put out of business.

There was a senate enquiry into the operations of the Customs Dept a couple of years ago which resulted in big changes to the way they operate. I know from first hand experience that the Federal Government ( both Liberal and Labor) has intervened more than once since the Pan case, to bring the TGA into line where they have overstepped the mark.

BTW, The Australian Taxation Office has also had its fair share of criticism in the past but it has actually been quite proactive in being more equitable in the way it does business ( may be not enough for some! :) )

[acmegridley]

70 million$ in compo. is not bad though is it by anyones measure:((

[Bushmiller]

70 million$ in compo. is not bad though is it by anyones measure:((

If that sum refers to the class action recently awarded, I guess it would depend on how many businesses share the award. I have no idea on that count. It is a bit like winning lotto. It becomes very important as to how many people share the prize. It would not surprise me to hear that many businesses went to wall as a result of the original recall.

They had no product for their shelves and the credibility of their business took a king hit.

If the same thing happened to the drug companies, would the doctors just pack up their bags and go home or would they call out their legal colleagues in droves and sue for all they were worth because their business had been effectively denigrated?

If the $70mil refered to Jim's payout (I think it was $50mil) I suppose it would have been alright if he got to take it with him! I know he was in the wintery years, but I doubt that level of stress would have contributed to his wellbeing.

Regards
Paul

[Bushmiller]

I have just done some research. The class action was apparantly for 170 people.

Regards
Paul

[ian]

As has been said great to see a polite rational discussion. I agree with most of what's been said on all sides, but I would like to comment on this:

vaccines are bad, (m'kay),

While I happily acknowledge they have prevented a lot of disease there are also a lot of people who have been disabled and even killed by them. Vaccines are not all good. If you go looking you'll find a few parents with dead kids (yes in aus) who are not as impressed with vaccines as they might be. I am not suggesting they are universally evil nor that the ill effects are particularly common. I resent both the panic mongering of the hippie/conspiricy brigade and the attempts by others to sweep the ill effects under the carpet. I am in favour of informing people so they can make up their own minds.I remember the effect that polio, hooping cough, diptheria and rubelia (german measels) had on kids and parents in my street and parent's social network when I was a kid.
I well remember my mother's take on child mortality -- there's plenty more where that one came from. A little callus? maybe, but both my parents were born immediately after the 1919 flu epidemic, grew up during the depression and managed to survive the fatal illnesses that have been mostly elliminated since the 1950s by vacines and anti-biotics.

There's been a lot of informed discussion about this issue in the past few years, and like it or not, once vacination rates fall below about 90% for some diseases, everyone of us is at increased risk.
Whilst my neighbour and I might reach different conclusions on the efficacy of vacinating our kids against hooping cough, if I decide not to while they do, my failure to vacinate puts their child at increased risk. Is this a reasonable, responsible action?
While I'll agree with you that the death of a child is hugely tragic, to a large extent one death in 100,000 is the price that must be paid to protect the herd.

[mic-d]

There's been a lot of informed discussion about this issue in the past few years, and like it or not, once vacination rates fall below about 90% for some diseases, everyone of us is at increased risk.
Whilst my neighbour and I might reach different conclusions on the efficacy of vacinating our kids against hooping cough, if I decide not to while they do, my failure to vacinate puts their child at increased risk. Is this a reasonable, responsible action?
While I'll agree with you that the death of a child is hugely tragic, to a large extent one death in 100,000 is the price that must be paid to protect the herd.

I agree, 100%

[rrobor]

Bushmiller to my mind is incorrect as to flu, a simple lookup found this
Influenza causes 2500 deaths, 80,000 GP visits and 15,000 hospitalisations among these groups of high-risk people in Australia each year. The best protection from influenza is vaccination, so anyone who wishes to protect themselves should get the injection.
Now that does not take into account lost production when ill and the like. A simple jab at about $40 stops that by building up your immunity without the risks, I for one get the jab.

[Master Splinter]

As an aside on the flu jab - I heard an interview on ABC News Radio the other day, where they were talking about Priceline Pharmacies offering flu jabs for $30 - the AMA spokesman was dead against the idea, and came up with the notion that since a flu shot costs $10-15 to buy, it was simply a cash cow for Priceline.

He seemed to gloss over the fact that doctors would also be paying the same amount for the shot, but charging $60-odd to medicare for the 10 minute consultation; so it's a cash cow for who????

[damian]

2 things:

1. I never said you shouldn't vaccinate. I said I endorse informed decisions and that they are not 100% flawless. Further if you adhere to the logic that we should be prevented from doing anything which might result in anothers death we need to all hand in our drivers licences right now. We also need to start arresting anyone who goes out in public with a cough or cold, and while we're at it lets book the people who use the chemicals my partner is allergic to. She and I both were worried we were going to lose her on a trip to NZ last year. Ridiculous ? Where exactly do you draw the line ?

2. The big payout figures sound great but after the payment is made (assuming it is) the lawyers take a cut then it's taxed as income. My partner looked into sueing AXA some years back for reniging on her income protection insurance when she got ill. Turns out unless she got the best possible result she would have gone bankrupt and even in teh best case might have ended up clearing $30k.

TP1: Agree totally. Unfortunately I too have first hand experience of modern Australian government. Not merely sad, absolutely tragic..