Heroes Not Zombies

Robert Ader is the forefather of the whole area of study known as psychoneuroimmunology (PNI). It amazes me that so few current graduates of medical schools have even heard of the term. Although it’s quite a mouthful, it is, simply, the study of the inter-relationships between the mind, the nervous system and the immune system. Together with psychoneuroendocrinology (the study of the mind, nervous system and endocrine system links), these areas of scientific study begin to help us to understand how the human being functions as a whole organism and how it’s pointless to consider the body and the mind as two distinct, separate entities.

He’s just published an interesting study on the clinical use of placebo. Starting from the understanding of the placebo effect as being, at least in part, akin to psychological, behavioural conditioning, and that such conditioning can exert physical changes in the body, he and his colleagues studied a group of patients with psoriasis.

They split the patients into three groups. One group applied a specified amount of steroid cream daily to their lesions, a second applied 25 to 50% of the strength of the steroid cream daily, and a third group applied cream which 25 to 50% of the time contained the full strength steroid and the rest of the time was a placebo (no steroid present).

The results are interesting, showing in particular that the group which received the placebo some of the time did as well as those receiving the full strength cream all the time, and better than the group receiving the lesser strength cream daily.

So what? Well, Ader and his colleagues point out that using placebo in this way could significantly reduce the amount of a drug required to have a desired outcome. Less drug means less side effects and less cost.

This is a novel study. Can the same phenomenon be found when applied to patients with other conditions? And for those who are concerned about the ethics, this was a fully informed, fully consented trial. There’s no reason why patients clinically couldn’t be given the choice to have treatments in this way……especially if further research confirms that the clinical outcomes are as good as using higher doses of drug more frequently.

Last week’s BMJ and Channel 4 News highlighted the highly dubious evidence base for Tamiflu.

In the process of updating their review, Jefferson et al found several important inconsistencies. Prompted by a reader of their previous update, they attempted to reconstruct the evidence from a much cited analysis on which they had based their previous conclusions. The analysis, by Kaiser et al, looked specifically at the effects of oseltamivir on the risk of hospital admission and complications (pneumonia and other lower respiratory tract infections) in people with influenza. Jefferson et al noted that the Kaiser analysis was funded by the drug’s manufacturer Roche and was based entirely on 10 trials funded by Roche, only two of which had been published as articles in peer reviewed journals. All 10 included trials were authored by Roche employees and paid academic consultants. The Cochrane reviewers could find no independently funded trials of oseltamivir in healthy adults.

Independant researchers have

concluded that they have no confidence in claims that oseltamivir reduces the risk of complications and hospital admission in people with influenza.1 In doing so they have reached a similar conclusion to the Food and Drug Administration in the United States and the recent health technology assessment performed for the UK’s National Institute for Health and Clinical Excellence (NICE), which both conclude that there is insufficient evidence on complications

So, why has the UK government given £500 Million (yes, £500 MILLION) pounds to Roche to buy massive supplies of this drug? (In the US, they’ve spend about one and half billion dollars on it)

The issue of what does Tamiflu do if it doesn’t significantly reduce the chances of complications of hospital admissions has been summarised as reducing the duration of flu by about half a day.

The £500 million drug cost isn’t the whole problem. By setting up a flow-chart based telephone prescribing system Tamiflu has been given to hundreds of thousands of people without a proper diagnosis of influenza or swine flu. If you can’t start with the right diagnosis, how do you ever get the patient the right treatment?

So, what’s the explanation for the government’s strategy for managing  the “swine flu pandemic”?

Is this a good example of “evidence based medicine”? Is it a good example of rational practice or cost-effective practice in the NHS? I don’t think so