At the risk of sounding like a conspiratory theorist I must say that the TGA are obviously going to say that only their oversight and regulation guarantees the authenticity of drugs but a report in New Scientist a while ago showed that there is a high percentage of drugs sold in pharmacies that are not what they are supposed to be.
The TGA have a vested interest in promoting their own indispensability. In Australia the TGA will only consider whether to approve a drug if the “sponsor” (the company making it) “…applies and supplies supporting documentation.” This is why so many symptomatic treatments like Sativex are available in countries such as the USA, Canada, the UK, Spain and New Zealand but not here. These drugs have been approved by regulators like the FDA in the US but are not only not available here but many are not even being considered because the makers are only looking to the big markets, Ocrevus (ocrelizumab) or because drug companies can’t patent them as with high dose Biotin.
This may well be one good thing in a free trade agreement because it might mean that we do get access.
My experience since diagnosis of Primary Progressive Multiple Sclerosis (PPMS), an auto immune disease in which the immune system destroys brain and central nervous system cells, 7 years ago has convinced me that our regulatory system for approval of medical treatments involving drugs is in serious need of reform. It was originally conceived as a protection for the public against snake oil salesmen but the industry was quick to realize that this could be a restriction on profits and they have been very successful in debasing it. It has become a system that can be used by industry and governments to corruptly increase profits and prevent access to drugs that are banned because of 1960’s attitudes to drugs that have been abused recreationally.
I have participated in a phase 3 trial of Fingolimod (Gilenya) for 3 years and it became obvious that this was a strategy to manipulate the system to extend Novartis’s patent for, at least, 7 years. You may be aware that this drug was approved for other types of MS in 2008. Had PPMS been included in the trials at that time it would have been available, or been shown to be ineffective then. Given that they conducted a phase 3 trial now, and that this trial was been extended twice for a year each time, I’m sure that an effect was demonstrated. By excluding 10% of their ‘market’ they have been able to sell it to 90% of their ‘market’ at $3000/28 days worth for 7 years and will now be able to claim a new application and so start the clock again on their patent for 100% of their market and taxpayers will pay for this.
This example highlights 3 issues which, although they are not criminal because they are not illegal, are unethical and immoral. These are :
the manipulation of the patent system to extend the profits to the company. This is a serious rort and costs taxpayers through subsidies such as the PBS.
the price is derived from knowledge of how much can be screwed out of the system. The company would not be able to sell the drug at all at this price otherwise so this is a serious swindle of government funded systems.
the 10% of the ‘market’, people with PPMS, have been denied access to the drug for 7 years. This drug has been shown to slow the progression of the disease and there are no other treatments approved for PPMS. You are probably aware that the average progression of PPMS from diagnosis to death is 17 years so this is extremely serious for anyone waiting for this drug.
There is currently a move to get medicinal use of cannabis approved for use in terminal illnesses in Australia. This has been shown to have beneficial effects on symptoms including spasticity and there are drugs such as Sativex that are cannabis derivatives in capsule form (so no concerns about the dangers of smoking) that have been approved for treatment of spasticity in MS in the USA, the UK, Canada, Spain and in some cases New Zealand but are not available here.
We have had numerous examples of ridiculous restriction on the availability of drugs to people who need them such as opiates for pain in terminal cancer because they are addictive and cannabis for pain and nausea in terminal lung cancer because smoking can cause lung cancer.
I understand that Victoria has legalised medicinal use of cannabis but this is still not available and will only be available through the same system and so will be criminally expensive.
I am supportive of research and trials, I have been involved in 3 to date, as I understand that this, and my illness, is a learning opportunity for all concerned and necessary for the development of treatments. I do understand though that there are aspects of the system that range from out dated and ridiculous to the sort of thing that would normally be associated with organized crime. I think that the MS Advisory Council should be considering strategies to achieve a comprehensive review and reform of the aspects of the drug regulatory system that are shown to be unethical.
The FDA (US) is fast tracking the approval process for Genenteck’s ocrelizumab, a drug treatment for PPMS that has been used to treat other forms of the disease for some time but, again, PPMS was kept out of previous trials to be used to extend the patent. The TGA is currently not considering it. The way the system works it will be something like 10 Years before it is available here.
People like me don’t have 10 years to wait and once the damage is done in the brain there is very little that can be done to restore it so you will see that many of the concerns about possible QAQC are not relevant. When you have a degenerative disease that is destroying your brain and central nervous system and will progressively remove your motility, cognition, continence and possibly eye sight and cause neurological pain resulting in you being curled up in a bed unable to feed yourself or wipe your backside your perspective changes. There is no cure and no treatments are available here. Treatments that are available elsewhere are denied here by our regulatory system so I am not swayed by arguments from the TGA who are self serving in that in almost every case their assessment of any drug for efficacy and safety is simply replicating that done in the USA or Europe and years before.