'Marketing based medicine': how bad is it?

It should be the scandal of the century. It potentially affects the health of almost everyone. Healthcare providers and consumers alike should be up in arms. But apart from coverage in a few credible news sources the problem of 'Marketing Based Medicine,' as psychiatrist Dr Peter Parry terms it, hasn't as yet generated the kind of universal outrage one might expect.

If you bought a new car and there was only a one in twelve chance that it would work properly, how would you feel? And what if there was a one in three chance that it was downright dangerous? Faced by these sorts of statistics, most consumers would be furious. And yet according to an articlein the 'Journal of Law, Medicine and Ethics', entitled 'Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs' this may well be the state of affairs with pharmaceutical products.. The "…..proportion of new products with clinical advantages seems to have moved from about 1 in 8 down to 1 in 12, while the proportion with serious harms has gone up from 1 in 5 towards 1 in 3 ......" 

Strangely a public outcry seems slow coming.

The problem largely emanates from a long term contamination of the medical evidence base by pharmaceutical marketing concerns, and incestuous relationships between drug companies, regulatory bodies, policy makers and media. The problem has become so pronounced that it has sparked a revolution in the British medical establishment, and the formation of the 'All Trials' initiative. Starting in January 2013 'All Trials' is attempting to get to the bottom of what products and procedures actually do what they claim, and which do not. A problem has been that pharmaceutical companies are not required to reveal all of their clinical data, so adverse findings are simply not making it into medical publications. Another factor is the large percentage of clinical guidelines being written by people with links to drug companies – The Lancet revealed in 2002 that it may be as much as 90% of all guidelines that are now compromised in this manner. By controlling the terms of reference drug companies have been able to skew the results.

But worse than this is the revelation that articles in medical journals are being 'ghost written' by people with financial links to drug companies, and that this has been largely hidden by non disclosure agreements. In short massive fraud is involved leading epidemiologist Dr Ben Gold acre, a driving force behind 'All Trials', to declare that everything we know about modern medicine may well have to be re written.

Whilst it is one thing for pharmaceutical marketing to have infiltrated the medical journals that professionals and policy makers rely upon to make informed decisions, the rot goes far deeper. .The Huffington Post alleges that the Centre for Disease Control in America massively inflated flu morbidity figures, by including figures for other similar illnesses, then "….. unabashedly decided to create a mass market for the flu vaccine by enlisting the media into panicking the public. An obedient and unquestioning media obliged by hyping the numbers, and 10 years later it is obliging still."

And the flu jab itself is certainly not without its critics, most notably Dr Tom Jefferson of the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics who undertake rigorous assessments of medical procedures and products. He states that the 'flu vaccine showed "no effect on specific outcomes: laboratory-proven influenza, pneumonia, or deaths from pneumonia". In other words, the 'flu policy, while eminently agreeable, is unsupported by evidence that has been systematically collected, critically evaluated, and properly synthesized". The " 'trust us, we're experts' pose, ……. is only fit for underlings, not intelligent, responsible healthcare workers…..".

This isn't America of course, but we are often influenced by their media and policy precedents. And we have to question to what extent our policy makers and media are being influenced by material that has been contaminated by pharmaceutical marketing concerns. The situation is bad enough to prompt psychiatrist Dr Peter Parry to proffer the term 'Marketing Based Medicine'. He suggests that we no longer have 'Evidence Based Medicine' at all, and the only way to repair the damage and restore credibility to pharmaceutical products is the adoption of the 'All Trials' initiative, or something like it, which will rigorously pursue independent testing.

Early in April this year the Cochrane Collaboration finally got the information they wanted from pharmaceutical giant Roche, concerning its product 'Tamiflu'. It had taken about five years and proven a frustrating experience. What it revealed was that the British government had spent about half a billion pounds on a product that did little if anything to remediate the effects of flu. "Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia". As Goldacre notes, it "….. is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story".

Worse still is the fact that the Cochrane Collaboration believes that Tamiflu may have a number of side effects. "Since percentages are hard to visualise, we can make those numbers more tangible by taking the figures from the Cochrane review, and applying them. For example, if a million people take Tamiflu in a pandemic, 45,000 will experience vomiting, 31,000 will experience headache and 11,000 will have psychiatric side-effects. Remember, though, that those figures all assume we are only giving Tamiflu to a million people: if things kick off, we have stockpiled enough for 80% of the population. That's quite a lot of vomit".

Goldacre contends that the whole episode illustrates the failures of regulation and transparency that permeate the pharmaceutical industry. "This is a pivotal moment in the history of medicine. Trials transparency is finally on the agenda, and this may be our only opportunity to fix it in a decade. We cannot make informed decisions about which treatment is best while information about clinical trials is routinely and legally withheld from doctors, researchers, and patients. Anyone who stands in the way of transparency is exposing patients to avoidable harm. We need regulators, legislators, and professional bodies to demand full transparency. We need clear audit on what information is missing, and who is withholding it."

But as an article in the Guardian reveals, "… the pharmaceutical industry has not been idle. It has"mobilised" an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials. Drug companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could re analyse their results and check companies' claims about the safety and efficacy of drugs." Clearly some pharmaceutical companies are opposed to such scrutiny, and one concern is that even if All Trials gains traction, they may find ways to circumvent 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'.