Evidence-based medicine or marketing-based medicine?
The tactics used by the pharma industry to entrench its influence – whether with politicians, health groups or prescribers – have been hitting the headlines lately.
A story on the cover of the SMHS’s Weekend Business section (beats me why it wasn’t on the paper’s main cover) examined how the industry buys influence in Canberra, and last week Sun Dunlevy splashed in The Daily Telegraph on pharma funding of patient and other health groups. (For more about this particular story, see the bottom of the post)
Meanwhile, Dr Peter Parry, a psychiatrist and senior lecturer at Flinders University, has been investigating internal pharma documents and has come to the conclusion that we live in a world of “marketing-based medicine”. He writes:
“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data…” AstraZeneca publications manager in internal email 6 Dec 1999.
In recent years doctors and other health professionals have been exhorted to practice “Evidence-based Medicine” or “EBM”. We should prescribe to our patients the right medication based on the best available medical science. Similarly surgeons should select the right implantable prosthesis according to EBM.
However there has been a growing tide of voices claiming EBM is not what it seems, that given the multi-billions of dollars involved, the medical science system has been distorted. The big pharmaceutical companies spend around 11% to 15% on research and development, but they spend around 36% of their budgets on marketing. This influence means much of what passes as EBM, may in fact be “MBM” – “Marketing-based Medicine”.
Despite (or because of) being wined and dined in style, the voices of dissent are coming from the medical profession. Specialist colleges, medical associations, committees of medical journal editors are facing the fact that what seemed too good to be true – was in fact not true and a crisis of trust in the medical literature is emerging.
Take 3 voices – all have been chief-editors of prestigious medical journals. Richard Horton of the Lancet said “Journals have devolved into information laundering operations for the pharmaceutical industry” in an article “The Dawn of McScience” . Marcia Angell of The New England Journal of Medicine wrote “Drug companies & doctors: A story of corruption”. Richard Smith was for 25 years an editor at the British Medical Journal (BMJ), the last 13 of those he was editor-in-chief. He wrote a paper entitled “Medical journals are an extension of the marketing arm of pharmaceutical companies”.
The medical scientific literature is built upon the gold-standard of the randomized controlled trial (RCT) and peer-reviewed journals. Much of what is published may be a true reflection of the raw data found in the RCT, but much may not. At present there is little way of telling – except that according to a large meta-analysis in the BMJ – a pharmaceutical company sponsored RCT has a 4-fold chance of finding the sponsors’ patented drug beats placebo or a competitor drug, than if the RCT was done independently.
Smith reflects it took him “almost a quarter of a century to wake up to what was happening” because “…editors may thus be peer reviewing one piece of a gigantic and clever marketing jigsaw—and the piece they have is likely to be of high technical quality”.
The large “marketing jigsaw” consists of pharmaceutical companies “owning” the raw data, RCTs being biased in favour of the sponsors’ patented drug, “ghost-writing” of papers with “honorary” high profile medical authors, [medical writing companies specializing in getting papers published in high-impact journals, continuing medical education (CME) including conferences funded to the hilt by the pharmaceutical industry and paid stables of “key opinion leader” (KOL) and “thought leader” doctors to educate their colleagues.
Doctors certainly may not consider themselves part of a company’s stable of KOLs and thought leaders, and speak according to the literature as they assess it, but internal company documents consistently talk of “their” doctors in this way.
Finally there’s the humble pharmaceutical sales rep who acts partially as a distraction so we think the marketing only lies with her/him.
I am a psychiatrist and it seems my specialty has been particularly exposed to MBM. A cross-roads moment for me was during the British & Irish child psychiatry conference in Edinburgh 5 years ago at a (heated) symposium about whether that conference should accept pharmaceutical company funding. At the end the colleague sitting next to me, who was extremely senior and well respected in the Royal College of Psychiatrists, said to me: “it has got to the stage I no longer know whether one can trust any RCT in any journal”.
In recent years internal pharmaceutical company documents have been released to the public domain from litigation with large fines and settlements against pharmaceutical companies, including reportedly the two largest criminal fines in history against Eli-Lilly and Pfizer.
Glen Spielmans, a psychology professor from Metrostate University in Minnesota, and myself read through around 400 such documents to do with several psychiatric medications. They provide evidence to support the claims of the esteemed chief-editors quoted above. Our paper “From evidence-based medicine to marketing-based medicine: evidence from internal industry documents” is published in the journal Bioethical Inquiry. It includes the insightful quote from the AstraZeneca publications manager from the start of this short essay, and much more.
Of particular interest to me were documents discussing weight gain with one of the newer antipsychotic drugs. How the company had data pointing to significant weight gain, but pushed a “weight neutral” message in published RCTs and other marketing. I prescribed that antipsychotic to several young patients on the basis of it being “weight neutral”, consequently at least 3 (as I recall) of those young people developed or worsened their obesity.
Industry counters that the litigation documents are “cherry-picked” (a term used in some documents to describe massaging of data) to show the worst side of the industry. That may be true, the documents do come following subpoena to courts. However there is now an extensive library of such documents online, readers can judge for themselves.
For our paper most of the documents we accessed are available at:
Sickness is part of the human condition. Doctors and pharmaceutical companies are necessary. Medications are necessary. And medications generally work, but MBM spins them to work better than they do, to seem to work for other conditions that they don’t really work for, and to appear more side-effect free than they really are, and to almost always seem better than the old off-patent drugs.
It is not that everything one reads in medical journals is corrupted, it is that you just don’t know what is. An analogy would be the subprime mortgages distributed through financial derivatives that sparked the global financial crisis. Today a similar crisis of trust pervades medical science.
The pharmaceutical industry is a competitive capitalist industry. Its bottom line is making money. It can be argued the ethical problem lies with the medical profession for allowing itself to be so marketed to. Also pharmaceutical companies have many good people wanting their industry to focus on health above all.
It is the medical profession’s responsibility to disentangle the co-dependent relationship. That would lead back to EBM and free up companies to transfer funds from marketing to R&D. Humanity would benefit from more innovation of better drugs. Interesting comments from industry insiders to our paper can be read on the Pharmalot blog.
There are moves towards reform. Journals are tightening the screws on conflicts of interest. Mandated registries of RCTs allow awareness of what (possibly negative for the patented drug) trials don’t get published and how close published trials reflect their original aims. Specialty colleges are reducing reliance on industry sponsored CME.
The Indian Medical Council appears to be currently leading the way, with strict rules upon doctors in India, including no acceptance of gifts or grants from pharmaceutical companies and only to do RCTs if the doctor gets a clause inserted in the contract that he/she effectively has full rights to the raw data and full control over publishing.
That sounds like a big stride back towards EBM.”
PostScript from Croakey re Daily Telegraph article:
1. The Cancer Council has been in touch to alert us to a glitch in the article. The organisation does not take funding from pharma, and this will come as no surprise to anyone who has read the MJA article by its ceo Ian Olver on related issues. Olver says of the DT article “although it mentions Cancer Council as receiving funds from Glaxo this is not Cancer Council Australia. On Glaxo’s website the detail is CCVic and CCNT but the “support” applies to small donations to charity events like Australia’s biggest Morning Tea.”
2. The DT article said: “Professor Phillip Mitchell, who heads the NSW University School of Psychiatry, last year revealed he received $6500 in fees from drug companies for lectures and service on advisory boards. He vowed to shun future handouts.”
This brief mention doesn’t really seem to do justice to Mitchell’s strong cry in the MJA for Australian doctors and medical institutions to “drastically improve the transparency of their interactions with industry, both in terms of the remuneration received and disclosure of potential conflicts of interest”. His article is well worth reading, if you haven’t already.