Editorial Note: For the past two months while there have been a series of authors on RxISK posts, David Healy has run a Persecution of Heretics series on davidhealy.org. The heresy is that drugs come with side effects – that they are poisons that can be put to close to magical use if both doctor and patient know they are dealing with a poison – See Persecution: Professional SUI Cide.
This heresy is of importance to everyone who consults a doctor. There is tremendous pressure on doctors to see the pills as magical rather than poisons – pressure they are not ordinarily aware of. The pressure that is there the whole time only comes into view should anyone challenge the system. It is this pressure that makes most doctors pretty hostile when faced with anyone stating their pills are causing a problem. The whole point behind RxISK is to try and even the power imbalance. We will have a few posts on this theme over the next few weeks.
This post accompanies a talk I gave at the Hay on Wye HowTheLightGetsIn Festival this May, called The Persecution of Heretics. The talk can be seen here. and an accompanying article, a variation on this post, is here.
When you click on the video it will invite you to register with The Institute of Art and Ideas. It’s free to do so and life is much easier if you do.
There are two articles that cover the content of the video – Medical Partizans and Academic Stalking available here.
Behind the apparent Biblical Authority of the Clinical Trial Literature in medicine lies an Inquisitional like apparatus run by company PR agencies and agencies whose job it is to manage the perception of science, linking in academics, aimed at silencing dissent and ensuring that prescribing doctors continue to prescribe. It focusses most clearly on anyone who suggests that a Brand name drug might have significant adverse events.
Such a person will be harassed in a range of ways, including being referred to the General Medical Council (GMC). There is a need for the full details of the many ways harassment can be carried out to see the light of day.
At the time the talk was being given, unknown to me, I was again being referred to the GMC.
The stake at which the heretic ends up is in the broad light of day but the persecutor hides in the shadows.
For millennia we have struggled with death and disease. In the 1950s, there was a huge increase in the number of truly effective medicines and this has played a part in improving life-spans and quality of life, in particular among children. These new drugs supported the creation of the National Health Service as treatments that work will make populations healthier and more effective at work and the provision of services offering treatments that work will pay for themselves and will make a country better able to compete with others.
Although almost all new treatments emerged without a clinical trial in sight, following the thalidomide crisis in 1962, clinical trials were put in place as a way to evaluate treatments. The established wisdom now is that clinical trials reveal the truth about medicines – they are the gold standard method of evaluation – and that once a trial confirms that a drug works, doctors should give them, and guidelines should enforce the giving, and health systems should make these treatments available at whatever cost as if effective they essentially pay for themselves.
Another safeguard put in place was that even though prescription only was a status for medicines invented to control addicts, all new drugs would be made available on prescription only. This puts doctors very clearly centre stage.
The view that medicine should be evidence based and that doctors should adhere to the evidence has become increasingly solidified in recent years. Linked to this an ever increasing proportion of the population is on an ever greater number of medicines for ever longer periods of time.
Meanwhile, treatment induced death has become one of the three leading causes of death and it now takes decades before doctors recognize a link between serious life threatening adverse events and treatment where such recognition used to be much quicker.
The medical literature has become ghost-written with close to the entire literature stemming from clinical trials of on-patent drugs ghost-written and the raw data from those trials is inaccessible. Nobody – not even the regulators – gets to see it.
In the face of this, the standard response from medicine has been that the problems lie within the pharmaceutical industry and that the only issue for doctors is one of conflicts of interest and this problem can be solved if doctors declare any conflicts they have.
Whatever about the pharmaceutical industry, doctors are good people who are trained to make sure you get the right treatment and the General Medical Council (GMC) takes care of those few doctors who might pose a risk to your health.
Latterly with the realization that clinical trial data has been concealed, there has been more of a push for access to Clinical Study Reports – the written in the company account of what its study shows. Doctors and medical researchers apparently don’t want to or can’t be trusted to have access to patient level data for reasons of confidentiality.
While there are some things we are not happy about happening within the pharmaceutical industry, medical journals and individual doctors have the belief that they are effectively drawing attention to problems and that individual doctors attempting to raise issues will find their colleagues supportive.
In fact adverse events now take 10-20 years from the time they are reported first to the point where it is accepted they can happen. Randomized controlled trials have become the Gold Standard way to Hide adverse events and the blind adoption of trials is a mistake of historic proportions. The National Health Service meanwhile is on its way to being transformed into a system to deliver clinical trial patients to pharmaceutical companies.
It is extraordinarily easy to intimidate doctors. One simple clinical misstep can provide an opportunity for a complaint against a doctor. And clinical practice inevitably gives rise to missteps. Once it does, the GMC can be used as a weapon to persecute heretics.
Wonderful though the GMC can be, its role is asymmetric. It will not take action against doctors working for pharmaceutical companies who put out grossly misleading information about the lethal hazards of the latest blockbuster drug. It won’t take an action based on its own Good Prescribing Practice against doctors who without seeing the data put their names to ghost written articles that are part of a marketing strategy to encourage doctors to prescribe drugs that are ineffective and dangerous.
Far from being trained in one of the major determinants of clinical practice, doctors have no training in how pharmaceutical companies market drugs, no knowledge of how to investigate adverse events and they are becoming ever less able to hear awkward messages coming from patients.
The pressure on doctors is vastly greater than they are aware and this can distort well-meaning people into not very nice people. Faced with a patient or a colleague questioning whether treatment is likely to have caused an adverse event or not, from cognitive failures on statins to suicidality on antidepressants, doctors feel threatened and are liable to turn nasty.
Try taking a RxISK report to a doctor and see. The response will tell you if you have a good doctor or not – if your doctor has The Right Stuff.
Interesting.I have yet to find a published report of adverse effects of biologics.Apparently no one is willing to publish the long term effects of these drugs.I have sen a number of patients with terrible side effects and sent a letter to the editor .No reply and no publication!
There have been several reports of psychosis on Enbrel. We published one a year ago.
There has also been a Cochrane review by Singh et al 2011: http://www.ncbi.nlm.nih.gov/pubmed/21328309
Dr Joanna LeNoury found this Cochrane Review of adverse effects reported in trials:
Singh JA et al (2011)
It makes some good points — but mainly about the failure of the controlled-trial literature to come clean about the nature and extent of the side effects.
As far as case reports, well, that’s interesting. I did a PubMed search of “lymphoma and adalimumab” just for kicks. Got several reports … all of them, it seemed, very recent, and all in what sounded to me like obscure specialty journals.
Has criticizing Humira just been downgraded from a felony to a misdemeanor?