Heroes Not Zombies

There are a couple of common views about new drugs amongst doctors. Both are based on the same phenomenon.

The first is “use new drugs quickly……..before their benefits wear off”

The second is “don’t use new drugs quickly……wait till you find out what there real effects are”

The phenomenon these views are based on is that when a drug first becomes available as a new “proven” or “evidence based” drug, it often seems spectacularly wonderful. Remember barbiturates? Benzodiazepines? Steroids? Betablockers? SSRIs? and so on and so on. When they first come to market they are described as breakthroughs (I don’t mean all the me-too drugs which just copycat the new ones). The early studies show wonderful outcomes and precious few side effects. However, it seems that frequently not only do the side effects become more predominant and problematic but the early promises turn out to be not quite so spectacular as originally believed.

It’s interesting to see this phenomenon now being more formally described.

But now all sorts of well-established, multiply confirmed findings have started to look increasingly uncertain. It’s as if our facts were losing their truth: claims that have been enshrined in textbooks are suddenly unprovable. This phenomenon doesn’t yet have an official name, but it’s occurring across a wide range of fields, from psychology to ecology. In the field of medicine, the phenomenon seems extremely widespread, affecting not only antipsychotics but also therapies ranging from cardiac stents to Vitamin E and antidepressants: Davis has a forthcoming analysis demonstrating that the efficacy of antidepressants has gone down as much as threefold in recent decades. For many scientists, the effect is especially troubling because of what it exposes about the scientific process. If replication is what separates the rigor of science from the squishiness of pseudoscience, where do we put all these rigorously validated findings that can no longer be proved? Which results should we believe?

I’ve said it before……this binary thought process of dividing treatments into “those which work” and “those which don’t” is nonsense. The world is not so simple. And “facts” are a lot more slippery and context bound (in time as well as circumstances) than a lot of “scientists”, and certainly drug companies,  would like us to believe.

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Doctors are taught to use two basic concepts – health and disease. Disease figures very predominantly on the medical curriculum. In fact, Davidson’s Textbook of Medicine is all about disease. There isn’t even an entry in the index for “health”. We create our “health services” around disease, with specialists who specialise in understanding and managing diseases of certain parts of the body. That’s why we have oncology departments, gynaecology departments, dermatology, cardiology, otolaryngology (ENT) departments and so on. Out in the world of Primary Care in the UK there’s an attempt to do it differently. Most Primary Care doctors work in “health centres”. However, especially since the introduction of the “Quality Outcomes Framework”, there’s been a further push towards concentrating on diseases rather than health.

This enormous emphasis on disease has led many doctors to act as if disease isn’t a concept at all. They treat it as if each disease is an independent entity. This is a misunderstanding. It’s also led to the development of so-called “evidence based” protocols for managing disease.

Where’s the attention paid to health (without reference to disease at all)? Where are the health experts as opposed to the disease experts? Have you ever wondered what a true “health” service would be like? One which addressed “health” either in addition to “disease” or as a first point of engagement with patients instead of the first point of engagement being once pathology has emerged? (and I do mean health as a whole organism state of being, not drugged psuedo-health!)

As I see it, it all depends on the timescale you consider. In acute illness, disease-focus strikes me as highly appropriate. It’s where we show the greatest effectiveness of pharmaceutical and surgical interventions. But in chronic illness, the disease-focus gets less and less useful. Here the emphasis needs to shift to a health-focus – and as health is a lived experience, that requires understanding and engaging with the human at an individual and whole-person level.

Disease is a biological dysfunction.

Health is a life state.

Disease impacts on health, and health impacts on disease. Don’t we need to address the issue of illness from both angles, emphasising what’s most important according to the time scale we’re considering?

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One thing that’s always surprised me about the way in which placebo effects are described is that they are portrayed as either the same as doing nothing, or as some kind of trick effect.

Clearly, giving a drug which randomised controlled trials show to be no more effective than placebo is not the same as doing nothing. Kirsch makes that very clear in the introduction to his book, “The Emperors New Drugs” where he shows the difference in depression between placebo groups and no treatment groups. But more than that, the placebo effect seems to be an integral part of the effect of any therapeutic intervention, whether that’s a drug or not. And, further, it’s not true that giving a chemically inert substance has no effect – it can produce what we call the placebo effect.

I recently read this article by Fabrizio Benedetti about the placebo effect and it’s one of the clearest articles on the subject I’ve ever read. He clearly maps out the chemical and neurological changes which occur in the body when a person is given a placebo. Here’s a small part of that description –

Placebo administration, along with verbal suggestions of analgesia (psychosocial context), might reduce pain through opioid and/or nonopioid mechanisms by expectation and/or conditioning mechanisms. The respiratory centers might also be inhibited by endogenous opioids. The β-adrenergic sympathetic system of the heart is also inhibited during placebo analgesia, although the underlying mechanism is not known (either reduction of the pain itself or direct action of endogenous opioids). Cholecystokinin (CCK) counteracts the effects of the endogenous opioids, thereby antagonizing placebo analgesia. Placebos can also act on serotonin-dependent hormone secretion, in both the pituitary and adrenal glands, thereby mimicking the effect of the analgesic drug sumatriptan.

Later in the article he points out that the chemical changes in the body don’t only occur in relation to pain pathways.

Although pain is the best known model to study placebo and nocebo effects, other conditions are now providing further insight into the biological mechanisms of placebos and nocebos. For example, patients who suffer from Parkinson’s disease have been shown to release dopamine after placebo administration [7] and also demonstrated changes in neuronal activity in the basal ganglia (fig. 5) [6]. Similar to the procedure in pain studies, patients were given an inert substance (placebo) and told they were receiving an anti-Parkinsonian drug that would produce an improvement in their motor performance. According to one hypothesis, the placebo-induced release of dopamine in Parkinson’s disease is related to reward mechanisms. In this case, the reward would be the clinical benefit.

This got me thinking. This is a good article for clarifying the REAL material changes which occur in human beings in response to the administration of inert substances. These changes are beneficial. Why don’t we study them more to understand them better, but, maybe even more importantly why don’t we stop thinking of these phenomena as something associated with trickery and deceit, but instead as important biological pathways in healing? The trouble is these pathways seem to be studied currently within the context of “dummy” and “pretend” interventions. Maybe we need to study them in relation to what are called “non-specific effects” – or in other words to the power of human care and interaction.

It’s time to change our priorities from a focus on technologies (drugs) to a focus on human beings (patients and practitioners)

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It always amazes me how people can speak with confidence about the placebo effect. Just what kind of phenomenon is it? Is it actually a manisfestion of self-organisation, of the biological ability to self-heal? If so, isn’t it something we should try to understand in order to maximise it?

Instead, placebo is frequently presented as “nothing”. The assumption is that a “placebo response” is not a “real” or “effective” response, and when used in randomised controlled trials, it is equated with doing nothing. In other words, if a treatment cannot demonstrate a statistically greater effect than a “placebo” it is considered to be “ineffective”. But is that true? Irving Kirsch has shown very clearly that “placebo” and “doing nothing” are far from the same, so it is illogical to argue that a treatment which produces a strong “placebo” response is “ineffective”.

Now here’s another interesting angle on the debate. A paper published in the Annals of Medicine about use of placebos in clinical trials points out that less than 10% of trials give any information about the make-up or content of the “placebo” used in the trial. Is this important? Well, they argue, yes, because sometimes the ingredients in the “placebo” produce a negative effect, and sometimes a positive one, but if we don’t know what was actually used, how can we make sense of the results?

This conclusion is fascinating –

“there isn’t anything actually known to be physiologically inert. On top of that, there are no regulations about what goes into placebos, and what is in them is often determined by the makers of the drug being studied, who have a vested interest in the outcome. And there has been no expectation that placebos’ composition be disclosed. At least then readers of the study might make up their own mind about whether the ingredients in the placebo might affect the interpretation of the study.”

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James Johnson, Chair of the BMA until 2007, is up in front of the GMC this month. He is….

alleged to have conducted operations that were not justified, shouted at a patient during a procedure and behaved like “a caricature of surgical arrogance”. A General Medical Council (GMC) fitness to practise panel was told that Johnson, who was chairman of the British Medical Association until 2007, also criticised the “incompetence” of colleagues in the operating theatre, did not warn patients about the risks of certain procedures and failed to provide proper care. Johnson is facing a series of serious disciplinary charges, relating to his conduct in regard to 14 patients on whom he operated between June 2006 and January 2008.

In this same week, Dr Geoffrey Hackett, a consultant urologist, says….

More than half the Viagra prescribed to men is not working….

So, that’s an “evidence based”, “proven” medicine, not doing what it says on the tin for more than half the people who take it (same as is the case for most of the drugs doctors prescribe)

Meanwhile, we hear that ghostwriters are writing “research” papers to promote drug companies’ products.

• Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal hormone therapy (HT), and to cast raloxifene and other competing therapies in a negative light.
• Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.

Also, Pfizer has been fined $2.3 billion

to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.

…this, the fourth settlement they’ve reached in such cases since 2002. Does it bother them? Obviously not, after all

the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales

Pfizer isn’t alone in this kind of behaviour, as the NY Times points out….

Almost every major drug maker has been accused in recent years of giving kickbacks to doctors or shortchanging federal programs. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would more vigorously prosecute doctors as well.

So, what do you think? Who’s got the big problems to sort out here?

We’re being conned by the dominant biotechnical model of medical practice which vigorously tries to denigrate and suppress any health care, traditional, alternative or complementary, which falls outwith the bounds of their own domain.

We need a better model of health care, one which focuses on the individual, which prioritises actually caring about patients, and which doesn’t promote a pill for every ill philosophy.

The American Board of Integrative Holistic Medicine principles would be a good starting point.

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I believe diagnosis is one of, if not, the most important parts of a doctor’s job. It’s actually the main goal of the entire medical undergraduate curriculum. However, we’ve limited what we mean by diagnosis. A diagnosis is not just the identification of pathology, it’s an understanding of a patient’s illness, a point which is all the more important when you consider patients with “co-morbidities” (more than one thing wrong).
In an interesting personal article in the BMJ Gordon Caldwell, a consultant physician working in acute medicine, says

The time taken to reach the correct diagnosis may be crucial for the patient’s chance of survival. Over my career I have seen many errors in the working diagnosis causing harm to patients and even death.

He also considers the importance of creating the right working environment for doctors to make good diagnoses

I believe that we have not thought about the best places, the physical and psychological environments, in which doctors should do this complex clinical thinking. Often it occurs in small hot rooms subject to constant interruption or even in ward corridors without easy access to laboratory results.

He concludes –

We must design our working spaces and information systems to maximise doctors’ ability to see, understand, and deliberate on the information needed for more precise diagnosis. We must allow clinicians enough time to be careful in diagnosis, treatment planning, and treatment review. We must urgently consider how to provide rooms, time, and information for doctors to do the most difficult part of their job and the part most prone to error: the clinical thinking in making the working diagnosis and treatment plan.

This is absolutely right. The scandal of the NHS is that we expect good health care to be provided without giving doctors adequate time with their patients to really understand them. We also frequently fail to provide good working environments and to share all the relevant information amongst the various members of the team.

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