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.