There is something seriously wrong when a major pharmaceutical company can veto patient safety and seemingly undermine the nation’s drug regulator to safeguard profits.
The Therapeutic Goods Administration (TGA) recently ordered two pain-management medicines off the shelves following concerns regarding their safety and efficacy. The drugs, Di-Gesic and Doloxene, were found by the TGA to be of questionable effectiveness in relieving pain and also have significant safety issues, with evidence that the drugs interfered with the electrical activity of the heart. This increases the risk of arrhythmia, when irregular beating of the heart can cause a wide range of serious consequences.
Using its regulatory powers, the TGA announced its intention to remove the products from the market, effectively banning sales in Australia. Two other drugs containing the same active ingredient, dextropropoxyphene, were also removed. Several other jurisdictions such as the US, UK, European countries and New Zealand have already removed these products from their markets in response to the same concerns.
Up until this point, the system to protect patient safety seems to have worked; the TGA stepped in to remove a dangerous product from the market once sufficient evidence of danger to everyday consumers, outweighing any potential benefits, had been identified.
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The story soured, however, when the products’ manufacturers, Aspen Pharmaceuticals, decided to challenge the ruling in the Administrative Appeals Tribunal (AAT) on an administrative technicality. The AAT then issued a stay order, effectively overriding the TGA’s concerns about consumer safety, and allowed the products to continue to be sold. Aspen was ordered to circulate strong warnings to doctors and pharmacists and place statements on the product itself.
The outcome is that the medication is still available on the market, and consumers are still at risk of very serious side effects.
There are two elements to this story that should concern all of us: the company involved appears to have put its corporate interests ahead of concerns about health and safety; and the TGA, Australia’s medicines regulator, has been sidelined by the decision of a quasi-judicial administrative panel.
In this day and age of triple bottom-line reporting and corporate responsibility, I find it amazing that Aspen Pharmaceuticals thought it in any way ethical or appropriate to immediately appeal on technical grounds and ignore the substantial medical evidence.
Aspen is entitled to recourse to appropriate legal remedies, and it should be afforded review and appeal. However, if Aspen is confident that these products were safe and effective it could have worked with the TGA to ensure regulatory compliance and demonstrate the appropriate management of potential risk to patient safety so the ban could be reversed.
Should Aspen should be putting the lives of its patients ahead of its own corporate interests? If it was serious about being a company dedicated to health and well-being, it would remove these products from the market until safety concerns could be properly addressed.
The second, and perhaps equally worrying issue, is the effective erosion of the TGA’s ability to use its expert knowledge to safeguard patient safety by the AAT.
The TGA does not often ban products. It thought it appropriate to fully remove Di-Gesic, Doloxene and other medications from the market and this should be enough to ensure these products are not available to the public unless they are proven to be safe and effective.
It does not bode well for future regulation that the very thorough and painstaking review of medications undertaken by the TGA can be easily overturned by a tribunal on a very narrow technical ground in the face of substantial evidence.
Aspen, a South African-listed company, has a $5.9 billion market capitalisation and boasts sales of more than $700 million in Australia and New Zealand. This level of resourcing enables it to pursue legal action and other strategies that can stall any efforts to remove products over which genuine concerns have been raised.
I think all Australians should be very concerned by this episode, and the apparent ease with which a major pharmaceuticals company can stall the actions of the nation’s drug regulator. At the end of the day, consumers trust the products they are being sold are safe and effective, have been appropriately tested and will not potentially harm their health.
When it comes to the behaviour of some big pharmaceutical companies, profits certainly take priority. Safety concerns may or may not.