“I may sound like a conspiracy theorist nut when I say this but the pharmaceutical companies are master manipulators…” begins Dr Martin Whitely, Senior Advocate for the WA based Health Consumers Council. “…
They rip off Australian taxpayers via the Pharmaceutical Benefits Scheme and pull the wool over the eyes of drug safety regulators everywhere.”
He is alluding to the overwhelming influence of the pharmaceutical industry on the medical evidence base, regulation and policy.
“When licensing drugs for marketing Australia’s Therapeutic Goods Administration (TGA) relies on research funded and controlled by pharmaceutical companies. Too often pharmaceutical companies ‘cherry pick’ favorable evidence and hide or ‘spin’ unfavorable evidence to support their commercial interests. Sometimes, as was the case for Vioxx and Pradaxa patients pay with their lives”, he stated in a submission to the Australian government on much needed reforms.
Whitely is not alone, increasingly medical professionals are coming to the realisation that much that they thought they knew about pharmaceutical products is a product of astute and pervasive marketing.
In 2002 the Lancet asserted that around 90% of clinical guidelines are being written by people who have financial links to pharmaceutical companies. Worse still, data from research is routinely withheld if it doesn’t support marketing goals. And even more unbelievably the peer reviewed literature in medical journals is often being ghost written by pharmaceutical employees, and this is being hidden via non-disclosure agreements. In short the highly vaunted medical evidence base, which is meant to be research based, is often little more than corporate marketing.
Recently Professor Peter Gotzsche, head of the Nordic division of the Cochrane Collaboration did a short speaking tour of Australia. His organisation is considered by many to be one of the foremost independent medical research bodies, and what he had to say about Big Pharma was damning. He makes a direct comparison with organised crime, pointing out that there is a well established track record of the sort of crime we would more usually associate with the Mob. Bribing officials, a breath takingly wide range of fraud and even withholding data on products known to be killers is sadly all too commonGotzsche claims.
And they are remorseless in exploiting any weaknesses in regulatory systems, which according to Dr Whitely is very much the case in Australia.“They game the system brilliantly”.
He served twelve years in the West Australian State parliament. This gave him an insight into the political processes, and his assessment of how it all works is not encouraging. He points out that politicians have to be generalists and rely upon expert advice. But in the case of expert advice on pharmaceutical products, the problem is that we have very few independent research organisations. Most pharmaceutical researchers rely on industry funding, even in a university context, and hence the experts the politicians hear from tend to be “the ones who can make a buck out of it”, and have the support of industry marketing. The work of the independent researchers, which may well be opposing the work of the industry funded groups, rarely comes to the attention of busy policy makers.
They simply do not have theconnections or the resources.
And this also applies to the media, who work around tight deadlines and “tend to have a fairly superficial understanding of the issues”. Whitely points out that “these are complex issues and journalists don’t have the time to do investigative journalism”. The fact that someone like James Murdoch has a senior position with a pharmaceutical company also speaks of the very many conflict of interest situations that pervade the industry. “Influence, charisma and relationships drives policy rather than science….”
To make the situation even worse for consumers, the adverse event reporting system is only giving us a “tip of the iceberg” and is “far from transparent and effective”. Whitely cites research that indicates that perhaps as little as 2% of adverse events are being reported by GP’s via the TGA’s voluntary system. Whatever the exact figure it is generally agreed that we have no real idea what the real figures for adverse events are. In short we simply can’t say which products are working as their maker claims, which are not, and which are causing harm. Consumers are also not being told about possible adverse events, and the whole notion of “informed consent” seems to be bypassed when it comes to pharmaceutical products. Big Pharma is also expert in creating mass hysteria about diseases which have low mortality, or even creating whole new diagnoses, thus creating new and ever expanding markets for their products.
And yet this government, and ones before it, continue to facilitate the Australian public into an ever greater uptake of pharmaceutical products of all descriptions. From psychiatric drugs to vaccines, from blood pressure medication to pain relief, pharmaceutical products cover a vast range of applications, and come in many different forms. Right now the general public is playing a vast game of Russian Roulette where we simply do not know the cost/benefit in terms of lives lost and saved, general health, and the nation’s finances. Gotzsche claims that pharmaceutical products are now the third biggest killer in Western nations, behind heart disease and cancer. It is an appalling statistic and yet the official narrative continues to be that they are “safe and effective” because Big Pharma pretty much controls the game.
Whitely has authored a submission to Australian parliament that outlines the magnitude of the problem and makes an urgent call for seven major reforms.
- Freedom of Information law reform as the current law provides the same protection to pharmaceutical company submissions to regulators and patients medical records. These submissions are used to justify the licencing and taxpayer subsidisation of pharmaceuticals and need to be subject to open scrutiny.
- Full public disclosure of all safety and efficacy data, with due regard to intellectual property. As things stand Big Pharma can withhold whatever data it wants, including that which may indicate a product is unsafe.
- Pre-registration of pharmaceutical research to help limit ‘cherry picking’ of favourable data. There are a lot of issues with this and Whitely doesn’t expect companies to give away a commercial advantage, but he supports a move towards an international ‘All Trials’ register.
- Adequate disclosure of risks to consumers on packaging. He wants to strengthen Consumer Medical Information (CMI) requirements so that the risks known to prescribers are also known to consumers. A CMI leaflet should be in all packaging and if there are serious risks these should be in a warning on the outside of the packaging.
- Mandatory reporting of serious adverse events. The problem with the current system is that it is voluntary and there is massive under reporting. A mandatory system would help identify problems early on and better protect consumers.
- Disclosure of potential conflicts of interest. It is vital that those providing advice to policy makers are insulated from pharmaceutical marketing and influence. Up until recently there has been very little attempts to enforce disclosure.
- Investigation into ‘off label’ prescribing, and moves to bring it ‘on label’. As things stand pharmaceutical products are being prescribed outside of the guidelines they were approved for. The extent of this problem is hard to gauge but seems to be substantial.
This is a very brief summary, Whitely goes into this in far more detail in his submission to parliament which can be found here: http://www.hconc.org.au/couch/uploads/file/hcc-senate-submission-on-pbs-tga-tranparency-reform-september-2014.pdf
He paints a picture of an industry that pretty much self regulates, and is only really guided by profits. How it got this way he summarises in a word – “money” – but he also suggests that it can only be expected that companies will take advantage of a regulatory environment that cuts them so much slack. It is difficult to think of any other similarly influential industry that exists in such a regulatory vacuum.
But of course there are people who seem to take the position that any mention of this makes one ‘anti pharma/medicine/science’. Whitely is quick to point out that this is very definitely not the case as far as he is concerned, and certainly not the intention of this submission. He uses pharmaceutical products, just like the vast majority of Australians, and recognises the many benefits that good products bring.
There is a strong argument that if the present situation persists and Big Pharma stumbles from one controversy to the next, overall confidence in pharmaceutical products and the medical establishment will be reduced. Reform will help create an environment of greater trust and good products will receive validation. The bad ones will deservedly go. He says that too many medical professionals and policy makers have an ‘intellectual blindspot’ when it comes to pharmaceutical products. But he has provided a blueprint for much needed reform in the sector, and articulated a vision for an industry that clearly needs it.
Footnote: Dr Whitely has been a prominent and effective critic of the prescription of amphetamines to children for ADHD and the ‘off label’ use of mental health medications including antidepressants and antipsychotics by children. His website www.speedupsitstill.com details many of these concerns.