'Marketing based medicine': how bad is it?

Australian psychiatrist Dr Peter Parry, and Glen Spielmans, an American psychologist, researched over 400 internal pharmaceutical company documents that were released as a result of litigation against the pharmaceutical industry by States and Federal attorneys generals in the USA. These court cases resulted in some of the biggest criminal fines in legal history. The documents revealed a systematic effort to bury or downplay negative data and maximise the positive spin on positive data for the manufacturers' drugs by the time data entered the medical journals, conferences and other medical education events. Spielmans and Parry published their research in the 'Journal of Bioethical Inquiry'.

Parry agrees that without reliable data it remains very difficult to assess the efficacy and safety of pharmaceutical products.

"As long as the raw research data can be concealed or spun – then the biggest problem remains. Hence the need for the "AllTrials" campaign to be successful. The British medical establishment is firmly behind the campaign. I'm hopeful our Australian and New Zealand psychiatry college, the RANZCP, will sign soon. The last communication I've seen on this is that our college is investigating the impact on our college journals. Journals can be vulnerable financially if AllTrials is implemented and less drug company sponsored studies are published because drug companies pay journals well for "reprints" of articles they use as handouts to doctors. I know several colleagues on our college journals' editorial boards and I am confident they would put ethics first. But it does mean a new business model for some medical journals in the world, especially those that publish lots of drug company sponsored research."

"MBM has in my view been widespread and endemic and dreadfully corrupting", states Parry. " It has led in my field of psychiatry to an over-focus on medication and diminution of non-drug therapies. It has led to spending on vastly more expensive on-patent medications which have minimal to no benefits over older off-patent medications. Even where benefit of a new drug is significant, it is debatable about whether benefit equates with the cost – as the money could've gone to other non-drug interventions that may with older medication have worked better overall. Academic careers have been built on close liaison with pharmaceutical companies, and other academic psychiatrists whose interest was on other aspects of psychiatry – have often been comparatively side-lined – this skews the whole ethos and discourse within the profession."

Dr Lucija Tomijanovic is a senior post doctoral researcher in vaccine safety at the University of British Columbia. She has co-authored papers with Professor Chris Shaw arguing that aluminium adjuvants can cause neurological harm in pediatric populations and states that "…..a more rigorous evaluation of potential vaccine-related adverse health impacts in pediatric populations than what has been provided to date is urgently needed". She contends that "in spite of the widespread agreement that vaccinesare largely safe and serious adverse complications are extremely rare, a close scrutiny of the scientific literature does not support this view." Her work is taken seriously by the French government who heard a submission from her and other scientists in May. As a result the French are seeking the removal of aluminum adjuvants where possible; supporting research into the accumulation of aluminum in the brain, and will not promote any mass vaccination programs using vaccines with aluminum in them. But what continues to underpin her work is the pursuit of compromises to good regulatory practice. In an investigation of some thirty years of documents pertaining to the British Department of Health and the Joint Committee on Vaccination and Immunisations, she concluded that the regulatory authorities and medical establishment often routinely under represented safety concerns. She states that the documents appear to show that "…… the JCVI made continuous efforts to withhold critical data on severe adverse reactions and contraindications to vaccinations to both parents and health practitioners……The transcripts of the JCVI meetings also show that some of the Committee members had extensive ties to pharmaceutical companies and that the JCVI frequently co-operated with vaccine manufacturers on strategies aimed at boosting vaccine uptake. Some of the meetings at which such controversial items were discussed were not intended to be publicly available, as the transcripts were only released later, through the Freedom of Information Act (FOI). These particular meetings are denoted in the transcripts as "commercial in confidence", and reveal a clear and disturbing lack of transparency……"

She believes that there is an institutionalized bias towards over stating efficacy and minimizing harm, and this in turn is often uncritically reported by the media.

Dr Peter Doshi is an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, and associate editor of the BMJ. He has become something of a poster boy for the clinical transparency cause. His back ground is in anthropology which gives him a skillset that is extremely useful in this context. Anthropologists are trained to dispassionately observe, record and interpret. For many medical professionals the idea that the edifice they base their expertise upon may be massively compromised is extremely confronting. For Doshi it presents an investigative challenge. Since 2009 he has worked with Dr Tom Jefferson on a Cochrane Collaboration

systematic review of neuraminidase inhibitors for influenza. This review has developed innovative methods for evaluating regulatory information including clinical study reports.

"I think it is now time to start considering the data sharing movement empirically", he states. ".Many companies have set out policies and are currently offering access to data. It is time for independent investigators, guideline committees, and public health bodies not accustomed to using previously confidential clinical trial data to do so - and in doing so, report on their experiences so that we can learn what is working and what is not."

Which leaves us with an industry that has committed what the Cochrane Collaboration describes as a 'laundry list of crimes', not least being fraud, hiding drug safety information, and collusion with regulators, policy makers and media. Since 1991 there have been some 239 legal settlements, totaling $30.2 billion.

So what can consumers and concerned healthcare providers do?

Firstly it's not all bad news. Dr Parry states: "The Australian College of Emergency Medicine recently signed the 'AllTrials' petition. That is the first specialty college in Australia that I'm aware of to do so ….. the Australian Medical Students Association signed in 2013." This is good news, particularly in regard to how the next generation of healthcare professionals will approach this issue.

But we need firm and decisive action from our policy makers, and we need it now. Policy makers, regulators, media and healthcare providers need to be protected and insulated from pharmaceutical marketing. The current situation where we are unable to definitively say which products work and which either don't work or may be harmful, is a giant game of Russian Roulette, with the odds firmly stacked against patients. Pharmaceutical companies that make good, effective products might see an opportunity to have their products independently validated, thus earning greater consumer trust. As Goldacre states, an opportunity now exists to get this right, and we all need to lobby hard to ensure it happens. The Cochrane Collaboration advises that we need to 'immunise' ourselves by 'asking questions and questioning answers'.